PRODUCT PACK SIZE PAGE NO.

Lypho CHEK
ACID PHOSPHATASE 5 x  2 mL 1
ALKALINE PHOSPHATASE 10 x  3 mL   2
CHOLESTEROL 4 x  50 mL /4  x  100 mL  3
CHOLINESTERASE 5 x  3  mL 4
CK‐MB 5 x  2.5mL 5
CK‐NAC 5 x  2.5mL 6
GLUCOSE  4 x  100 mL /4 x  250 mL/ 4 x  500 mL 7
SGOT  5 x  20 mL/4 x  50 mL  8
SGPT  5 x  20 mL/4 x  50 mL  9
TRIGLYCERIDES 5  x  20mL / 4 x  50 mL  10
UREA‐B 200 mL  11
UREA  U.V  4 x  50 mL / 4 x  100 mL  12
URIC ACID 5 x  20 mL/ 4 x  50 mL 13
Liqui CHEK
ALKALINE PHOSPHATASE (S.L) 2 x  10 mL /2 x  30 mL/2 x  50 mL 14
ALPHA AMYLASE (S.L) 4 x  5  mL /4 x  10 mL 15
CHOLESTEROL(S.L) 5 x  25 mL / 5 x  100 mL/ 4 x  250 mL 16
CHOLINESTERASE  ( S.L) 2 x  10 mL 17
CK‐MB (S.L) 2 x  12.5 mL/2 x  20 mL 18
CK‐NAC (S.L) 2 x  10 mL /2 x  30 mL 19
ENZYMATIC  CREATININE (S.L) 2 x  40 mL /2 x  60 mL/4 x  60 mL 20
GAMMA GT (S.L) 2 x  10 mL / 2 x  30 mL 21
GLUCOSE (S.L) 5 x  100 mL /1 x  1000 mL 22
HDL ‐ C  DIRECT 2 x  40 mL /2 x  60 mL / 4 x  60 mL  23
LDH ‐ P (S.L) 2 x  10 mL /2  x  30 mL 24
LDL ‐ C  DIRECT 2 x  40 mL /2 x  60 mL  25
LIPASE (S.L) 1 x  25 mL 26
SGOT (S.L) 3 x  20 mL /3 x  50 mL / 4 x  125 mL  27
SGPT (S.L)  3 x  20 mL / 3 x  50 mL/ 4 x  125 mL 28
TRIGLYCERIDES (S.L) 4 x  10 mL /5 x  25 mL / 6 x  50 mL/ 5 x  100 mL 29
UREA U.V (S.L) 2 x  30 mL / 2 x  50 mL / 2 x  125 mL 30
URIC ACID (S.L) 2 x  30 mL / 2 x  50 mL / 2 x  100 mL 31
ChemCHEK
ALBUMIN 4 x  50 mL 32
BILIRUBIN DIRECT 4 x  50 mL 33
BILIRUBIN TOTAL  ‐TAB 4 x  50 mL 34
BILIRUBIN TOTAL 4 x  50 mL 35
BILIRUBIN TOTAL& DIRECT 4 x  50 mL 36
CALCIUM 4 x  25 mL / 4 x  50 mL 37
CALCIUM (ARSENAZO) 4 x  25 mL 38
CHLORIDE 4 x  50 mL 39
COPPER 2  x  25mL 40
CREATININE 4 x  50 mL 41
HAEMOGLOBIN 1000 mL 42
HDL‐CHOLESTEROL 4 x  25 mL 43
INORGANIC PHOSPHOROUS 4 x  25 mL / 4 x  50 mL 44
IRON 2 x  50 mL 45
MAGNESIUM 4 x  25 mL 46
MICROPROTEIN 1  x  50 mL 47
TIBC 50T 48
TOTAL PROTEIN 4  x  50 mL 49
ZINC 2  x  10mL 50
SensIT
ALPHA1ACID GLYCOPROTEIN  WITH CALIBRATOR 1 x  20 mL/1 x 10ml/1ml 51
APOA1 WITH CALIBRATOR  1 x 30ml/1 x 5ml/1ml  52
APOB WITH CALIBRATOR  1 x 30ml/1 x 5ml/1ml  53
PRODUCT PACK SIZE PAGE NO.
ASO   LATEX  WITH  CALIBRATOR 1 x 45ml/1 x 5 ml/1ml 54
ASO   LEIT  WITH  CALIBRATOR  1 x 24ml/1 x 8 ml/1ml, 2 x 24ml/2 x 8 ml/2ml  55
C3 WITH CALIBRATOR  1 x 30ml/1 x 5ml/1ml  56
C4 WITH CALIBRATOR  1 x 30ml/1 x 5ml/1ml  57
CERULOPLASMIN WITH CALIBRATOR  1 x 30ml/1 x 5ml/1ml  58
CRP   LATEX  WITH  CALIBRATOR 1 x 45ml/1 x 5 ml/2ml 59
CRP   LEIT  WITH  CALIBRATOR  1 x 24ml/1 x 8 ml/2ml, 2 x 24ml/2 x 8 ml/2ml  60
CRP ULTRA  WITH CALIBRATOR  1 x 18ml/1 x 9ml/2ml  61
CYSTATIN C WITH  CALIBRATOR  1 x 25ml/1 x 5ml/2ml  62
FERRITIN+CALIBRATOR  1 x 30ml/1 x 10ml/1ml  63
HBA1C DIRECT  WITH  CALIBRATOR 4 x 7.5/1 x 9.5/1 x .5/4 x .5 mL 64
IgM WITH CALIBRATOR  1 x 30ml/1 x 10ml/1ml  65
IgG WITH CALIBRATOR  1 x 15ml/1 x 15ml/1ml  66
IgA WITH CALIBRATOR  1 x 30ml/1 x 10ml/1ml  67
IgE WITH CALIBRATOR  1 x 32ml/1 x 8ml/1ml  68
LIPOPROTEIN (A) WITH  CALIBRATOR  1  x  20mL/1 x 4mL/1mL  69
MICRO ALBUMIN LATEX WITH  CALIBRATOR 1 x  45 mL/1 x 5mL/1mL 70
MICRO ALBUMIN  IT WITH CALIBRATOR  2  x  25mL/2 x 5mL/1mL  71
PREALBUMIN WITH CALIBRATOR 1 x  25 mL/1 x 5mL/1mL 72
RF LATEX  WITH  CALIBRATOR 1 x 45ml/1 x 5 ml/2ml 73
R.F LEIT WITH CALIBRATOR  1 x 24ml/1 x 8 ml/1ml, 2 x 24ml/2 x 8 ml/2ml  74
TRANSFFERIN WITH CALIBRATOR 1  x  30 mL/1 x 10mL/1mL 75
Sero CHEK
ASO   50 T / 100 T 76
CRP 50 T / 100 T 77
RF  50 T / 100 T 78
RPR 50 T /125 T / 500 T 79
BLOOD GROUPING
ANTI‐A 1  x  10 mL 80
ANTI‐A,B&D(IgG+IgM) 3  x  10mL 81
ANTI‐A,B&D(IgM) 3  x  10mL 82
ANTI‐B 1  x  10 mL 83
ANTI‐D (IgG+IgM) 1  x  10 mL 84
ANTI‐D (IgM) 1 x 10 ml 85
CoagTHREE
PT (SL) 2 x  4 mL 86
APTT  2 x  4 mL 87
HaemoCHEK
DILUENT  10 Litre /20 Litre 88
E‐Z CLEANER   4 x  50 mL 89
LYSE  500 mL /2 x  500 mL 90
PROBE CLEANER   4 x  50 mL 91
RINSE  10 Litre /20 Litre 92
CONTROLS & CALIBRATORS
ASO CALIBRATOR 1 x 1 mL 93
MICROALBUMIN CALIBRATOR 1 x 1 mL 94
CRP CALIBRATOR 1 x 2 mL 95
Lp(a) CALIBRATOR 1 x 1 mL 96
PROTEIN CALIBRATOR  1 x 1 97
MULTICALIBRATOR 5 x 3 mL 98
FERRITIN CALIBRATOR   1 x 1 mL 99
HbA1c DIRECT MULTI CALIBRATOR 4 x 0.5 mL 100
RF CALIBRATOR 1 x 1 mL 101
HbA1c CONTROL  LEVEL 1 &2 2 x 0.5ml 102
PROTEIN CONTROL(IMMUNOLOGY) 1 x 1 mL 103
QUALICHECK NORM & PATH 2 x 5 mL 104
PRODUCT PACK SIZE PAGE NO.
Mispa Nano
ALPHA 1‐ACID GLYCOPROTEIN 1 x 25mL /1 x4 mL 105
C3 1 x 35mL /1 x6mL 107
C4 1 x35 mL/1x6mL 109
APO A1 1 x 35/1x6mL 111
APO B 1 x 35mL/1 x 6 mL 113
CERULOPLASMIN 1 x 35 mL/1 x6 mL 115
PREALBUMIN 1 x25mL /1 x 4 mL 117
TRANSFERRIN 1 x 25mL /1 x 4mL 119
IgM 1 x 30/1 x 10 mL 121
IgG 1 x 15mL/1 x 15 mL 123
IgA 1 x 30mL/1 x 10mL 125
IgE 1 x 22mL/1 x 6.5mL 127
FERRITIN 1 x 20mL/1 x 11mL 129
CYSTATIN‐C 1 x 23mL/1 x 5.5 mL 131
HbA1c DIRECT 1 x 30/1 x 9.5/1 x 0.5/2x63mL 133
ASO 1 x 20/1 x 11 mL 135
CRP 1 x 20/1 x8 mL 137
RF 1x 20/1 x 8 mL 139
Lp (a) 1 x 23/1 x 5.5 mL 141
MICROALBUMIN 1 x 23/1 x 5.5 mL 143
CRP Ultra 1x20 / 1x11 mL 145
ALBUMIN 4 x 30 mL 148
ALKALINE PHOSPHATASE 2 x 30 / 2 x 8 mL 150
AMYLASE 2 x 30 mL 152
BILIRUBIN DIRECT 4 x 30 / 2 x 8 mL 154
BILIRUBIN TOTAL (TAB) 4 x 35 / 2 x 10 mL 156
CALCIUM (ARSENAZO) 2 x 35 mL 158
CHLORIDE 2 x 30 mL 160
CHOLESTEROL 4 x 35 mL 162
CREATININE 4 x 35 / 2 x 18 mL 164
CREATINE KINASE 1 x 30 / 1 x 8 mL 166
ENZYMATIC CREATININE 2 x 35 / 2 x 12 mL 168
GAMMA GT 1 x 30 / 1 x 8 mL 170
GLUCOSE 4 x 35 mL 172
HDL – C DIRECT 2 x 30 / 2 x 10 mL 174
LDH 1 x 30 / 1 x 8 mL 176
LDL – C DIRECT 1 x 30 / 1 x 10 mL 178
MAGNESIUM 1 x 30 mL 180
PHOSPHOROUS 1 x 30 mL 182
SGOT 4 x 35 / 2 x 18 mL 184
SGPT 4 x 35 / 2 x 18 mL 186
TOTAL PROTEIN 4 x 30 mL 188
TRIGLYCERIDES 4 x 35 mL 190
UREA U V 4 x 30 / 2 x 16 mL 192
URIC ACID 2 x 35 mL 194
 5 x 2 mL
ACID PHOSPHATASE 11201001
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of Acid phosphatase Mode of Reaction Kinetic
in serum.
Slope of reaction Increasing
- Alpha - naphthylphosphate method
- Linear upto 150 U/L Wavelength 405 nm
- Tartrate included for determination of non-prostatic acid phosphatase Temperature 370C
CLINICAL SIGNIFICANCE Factor 750
Acid phosphatase is present in lysosomes, which are organells present in all cells with Linearity 150 U/L
the possible exception of erythrocytes. The greatest concentrations of ACP activity Blank DI Water
occurs in liver, spleen, erythrocytes, platelets, bone marrow & the prostate gland which
is the richest source and it contributes a small portion of the enzyme present in sera Delay 300 sec.
from healthy males. No of reading 3
Determination of ACP activity in serum is almost directed toward the prostatic enzyme Interval 60 sec
with the intent of detecting or monitoring carcinoma of the prostate. Elevation of the
enzymatic activity of prostatic ACP & thus of total ACP activity are found in the sera Sample volume 100 µL
of about 60% of men with prostatic cancer & metastase. Reagent volume 1000 µL
Slight or moderate elevations in total ACP activity often occur in Pagets disease in Cuvette 1 cm light path
hyperparathyroidism with skeletal involvement & in the presence of malignant invasion LABORATORY PROCEDURE
of the bones by cancers, such as breast cancer in women, unlike prostatic ACP, in these
cases the serum ACP activity is not inhibited by tartrate. Total non inhibitor by tartrate fraction
Working reagent 1000 µL 1000 µL
PRINCIPLE Tartrate Solution R3 - 10 µL
Acid Phosphatase activity present in the sample is determined according to the Sample 100 µL 100 µL
following reactions.
Mix, and incubate for 5 minutes at 370C. Measure the change in absorbance per
Acid Phosphatase minute ( OD/min) during 3 minutes.
alpha - naphthyl-phosphate+H2O -----------------------> alpha –naphthol + phosphate
a-naphthol+ Fast Red TR -------------> Azo dye CALCULATION
Tartrate is used as specific inhibitor of the prostatic fraction. Total acid phosphatase (U/L) = 750 x ( OD/min.) of total
Non prostatic ACP activity (U/L) = 750 x ( OD/min.) of non inhibitor fraction.
REAGENT COMPOSITION Fraction of prostatic acid phosphatase(U/L) = Total ACP activity - Non-
ACID PHOSPHATASE R1 5 x 2 mL prostatic ACP activity.
Citrate Buffer (pH 5.2) 50 mmol/L BIBLIOGRAPHY
ACID PHOSPHATASE R2 (Tablets) 1 x 5 x 2 mL 1 Hillman G. Z., Clin.Chem. Biochem 9.273 (1971).
alpha–naphtylphosphate 10 mmol / L
Fast red TR 6 mmol / L
ACID PHOSPHATASE R3 1 x 1 mL
Sodium tartrate 2 mmol/L
STORAGE AND STABILITY
The sealed reagents are stable upto the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear upto 150 U/L
If the concentration is greater than linearity (150 U/L), dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
REFERENCE RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Total acid phosphatase:
Men : < 5.4 U/L
Women : < 4.2 U/L
Prostatic acid Phosphatase : < 1.7 U/L
PREPARATION AND STABILITY OF WORKING REAGENT
Dissolve one tablet (R2) with 2 mL of Reagent 1 (R1)
The working reagent is stable for 2 days at 2-80C.
Wait for 10 minutes for complete dissolution.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of working reagent to light.
Acid phosphatase is extremely temperature labile. The sample should therefore be
centrifugated immediately after coagulation. The serum should be cooled and proceed
as quickly as possible. Do not use hemolytic serum. If the serum is to be examined
after some time, its pH value should be adjusted to about 5 (0.02 mL acetate buffer
5 M per 1 mL of serum).
SAMPLE
Fresh serum only. Do not use plasma.

ADL/V.02/February 2013

1
 10 x 3 mL
ALKALINE PHOSPHATASE 11202001
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of Alkaline Phosphatase Mode of Reaction Kinetic
in serum or plasma.
Slope of reaction Increasing
- DGKC – SCE recommended procedure with DEA buffer
- Linear upto 900 U/L Wavelength 405 nm
- Working reagent stable upto 7 days at 2-80C Temperature 370C
CLINICAL SIGNIFICANCE Factor 2750
Alkaline phosphatase is widely distributed throughout the body, but clinically Blank DI water
important one for diagnostic reasons are in bone, liver, placenta & intestine. Growing Linearity 900 U/L
bone is associated with the release of ALP and so in childhood the level of ALP is
around 3 times of that of adult. During pregnancy in 2nd&3rd trimester the enzyme rises Delay time 60 sec
considerably due to placenta releasing ALP. It can be used to examine placental No of readings 3
function. Interval 60 sec
Elevated levels are seen in bone diseases, e.g. pagets disease, rickets, osteoblastic
metastatic & in obstructive disease of biliary tract. Sample volume 20 µL
Decreased levels are rarely seen. e.g. in Vitamin A resistant rickets. Reagent volume 1000 µL
PRINCIPLE Cuvette 1 cm light path
Kinetic determination of ALP according to the following reaction
ALP LABORATORY PROCEDURE
p-nitrophenyl phosphate + H2O-------- >p-nitrophenol+Inorgnic phosphate
ALP = Alkaline Phosphatase Working reagent 1000 µL
REAGENT COMPOSITION Sample 2µL
0
ALKALINE PHOSPHATASE R1 1 x 33 mL Mix and incubate at 37 C for one minute. Measure the change in absorbance per
Diethanolamine Buffer 1 mmol/L minute ( OD/min) during 3 minutes.
Magnesium Chloride 0.5 mmol/L CALCULATION
ALKALINE PHOSPHATASE R2 10 x 3 mL ALP Activity (U/L) = ( OD/ min.) x 2750
P-Nitrophenyl phosphate 10 mmol/L
BIBLIOGRAPHY
STORAGE AND STABILITY 1. Scand J. Clin. Lab. Invest. 32:29 (1974)
The sealed reagents are stable upto the expiry date stated on the label, when stored 2. Tietz, N.W..; Clin. Chem. 29:751 (1983)
at 2-80C. 3. Z Klin. Chem. U. Clin. Biochem. 8 (1970) 658; 10 (1972), 182.
LINEARITY
The reagent is linear, up to 900 U/L.
If the concentration is greater than linearity (900 U/L), dilute the sample with normal
saline & repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values. The
following value may be used as guide line.
Adults : 100 – 290 U/L
Children : 180- 1200 U/L
PREPARATION AND STABILITY OF WORKING REAGENT
Reconstitute the Reagent 2(R2) with the volume Reagent 1(R1) mentioned on the vial
label. The reconstituted reagent is stable for 7 days at 2-80C.
NOTE
Discard the working reagent if the blank absorbance exceeds 1.0 at 405 nm.
PRECAUTION
To avoid contamination, use clean laboratory wares. Avoid direct exposure of working
reagent to light.
SAMPLE
Serum / plasma (free of haemolysis)

ADL/V.02/February 2013

2
 4 x 50 mL, 4 x 100 mL
CHOLESTEROL 11204002, 11204003
INTENDED USE SAMPLE
This reagent is intended for in vitro quantitative determination of Cholesterol in serum Serum / Plasma (free of haemolysis).
or plasma.
GENERAL SYSTEM PARAMETER
- Cholesterol Oxidase Peroxidase methodology
- Linear up to 500 mg/dL Mode of Reaction End point
- Reconstituted reagent stable up to 90 days at 2- 80C Slope of reaction Increasing
- Lipemic clearing system, minimizes reruns Wavelength I 505 (492 -540) nm
CLINICAL SIGNIFICANCE Wavelength II 630 nm
It is the main lipid found in the blood, bile & brain tissues. It is also one of the most Temperature 370C
important steroids of the body & is a precursor of many steroid hormones. Two Standard Concentration 200 mg/dL
thirds of cholesterol present in the blood is esterified. The liver metabolizes the
cholesterol & it is transported in the blood stream by lipoproteins. Blank Reagent
Increased levels are found in hypercholesterolemia, hyperlipidemia, hypothyroidism, Linearity 500 mg/dL
uncontrolled diabetes, nephritic syndrome & cirrhosis. Incubation time 5 min
Decreased levels are found in malabsorption, malnutrition, hyperthyroidism,
anaemia & liver diseases. Sample volume 10 µL
Reagent volume 1000 µL
PRINCIPLE
Enzymatic colorimetric determination of total cholesterol according to the following Cuvette 1 cm light path
reactions. LABORATORY PROCEDURE
Cholesterol esterase Blank Standard Sample
Cholesterol ester +H2O ---------------------------> Cholesterol + fatty acids
Cholesterol esterase Working Reagent 1000 µL 1000 µL 1000µL
Cholesterol + O2 ---------------------------> 4-Cholesten-3- one + H2O2 Standard - 10 µL -
Peroxidase Sample - - 10 µL
2H2O2 +Phenol+4-Aminoantipyrine --------------> - Red quinone + 4H2O
Mix, and incubate for 5 min, at 370C. Measure the absorbance of sample and standard
REAGENT COMPOSITION against reagent blank.
CHOLESTEROL R1 4 x 50 mL / 4 x 100 mL
Pipes buffer (pH 6.90) 50 mmol/L CALCULATION
Phenol 24 mmol/L Cholesterol Conc. (mg/dL) =
Sodium Cholate 0.5 mml/L Absorbance of sample
CHOLESTEROL R2 4 x 50 mL / 4 x 100 mL ----------------------------- x 200
Cholesterol esterase > 200 U/L Absorbance of standard
Cholesterol oxidase > 250 U/L BIBLIOGRAPHY
Peroxidase > 1000 U/L 1. Arntz, H. R.; Diagnostik der Hyperlipoproteinamein, Lab, Med. 3/177, (1979)
4 – aminoantipyrine 0.5 mmol/L 2. Flegg, H.M.; Ann. Clin. Biochem, 10 (1973), 1350-1356
CHOLESTEROL STANDARD 1 x 4mL 3. Siedel, J., Schlumberger, H., et al. ; J. Clin.Chem.Clin. Biochem.19 (1981), 838.
4. Allain, C.C. et al.; Clin.Chem 20 (1974), 470
Cholesterol standard concentration 200 mg/dL
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2-80C.
LINEARITY
This reagent is linear up to 500 mg/dL.
If the concentration is greater than linearity (500 mg/dL), dilute the sample with
normal saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum / Plasma : 150 – 220 mg/dL
PREPARATION AND STABILITY OF WORKING REAGENT
Dissolve contents of Reagent 2 (R2) with the amount of Reagent 1 (R1) indicated
on the vial label.
The working reagent is stable for 90 days at 2-8 0C.
NOTE:Discard the working reagent if the blank absorbance exceeds 0.08.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of working reagent to light.

ADL/V.02/February 2013

3
 5 x 3 mL
CHOLINESTERASE 11205001
INTENDED USE: GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of Cholinesterase in
serum or plasma. ( OD/60 sec) ( OD/30 sec)
- Kinetic, Butyrylthiocholine method Mode of Reaction Kinetic Kinetic
- Linear up to 9084 U/L Slope of reaction Increasing Increasing
- Stability of working reagent is 2 hours at 2-80C Wavelength 405 nm 405 nm
CLINICAL SIGNIFICANCE Temperature 37 0C 37 0C
Cholinesterase levels in serum are useful as a test of liver function, as an indicator of Factor 22710 45420
possible insecticide poisoning or for detection of patients with atypical forms of Linearity 9084 U/L 9084 U/L
enzyme. Blank DI Water DI Water
Measurements of serum Cholinesterase activity can serve as sensitive measures of the Delay 2 sec 2 sec
synthetic capacity of the liver if the patient’s normal level is known. No of reading 2 4
Elevated levels (marginal increase) are observed in patients with nephritic syndrome, Interval 60 sec 30 sec
thyrotoxicosis & haemochromatosis in obese, diabetic people & in patients with
anxiety & other psychiatric states. Sample volume 20 µL 20 µL
Decreased levels are found in patients with acute infections, pulmonary embolism & Reagent volume 3000 µL 3000 µL
muscular dystrophy as well as after surgical procedures. After a myocardial infarction, Cuvette 1 cm light path 1 cm light path
the enzyme levels decreases until the 5th day & then begins a slow rise to normal.
Decreased levels are also found in chronic renal disease & in pregnancy. LABORATORY PROCEDURE
PRINCIPLE Working reagent 3000 µL
Cholinesterase Sample (dilute 1+1 with saline solution.) 20 µL
Butyrylthiocholine + H2o --------------->Thiocholine + Butyrate Mix and measure the change in absorbance per minute ( OD/60 sec)
during 2 minutes. Or measure the change in absorbance per 30 sec ( OD/30 sec)
during 2 minutes.
Thiocholine + Dithio-bis-nitrobenzoate--------------> nitro -2- mercapto-5-
benzoato CALCULATION
Cholinesterase activity (U/L) =
REAGENT COMPOSITION
( OD/60 sec) x 22710
CHOLINESTERASE R1 5 x 3 mL
or
Buffer Solution
( OD/30 sec) x 45420
Phosphate buffer, (pH 7.7) 50 mmol/L
CHOLINESTERASE R2 1 x 5 x 3 mL BIBLIOGRAPHY
Tablets Kendel, M., Yotros.; Kin. Wschr. 45, 325 (1967)
5,5 DTNB 0.25 mmol/L
Butyrylthiocholine 7 mmol/L
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2- 80C.
LINEARITY
This reagent is linear up to 9084 U/L.
If the concentration is greater than linearity (9084 U/L), dilute the sample with normal
saline and repeat the assay.Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum : 4659-14443 U/L
PREPARATION AND STABILITY OF WORKING REAGENT
Dissolve one tablet R2 in one vial of Reagent 1 (R1). The stability of working reagent
is 2 hours at 2-80c.
NOTE : Wait for 10 minutes for complete dissolution.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of working reagent to light.
SAMPLE
Fresh plasma (free of haemolysis), serum.

ADL/V.02/February 2013

4
 5 x 2.5 mL
CK MB with Calibrator 11207004
INTENDED USE PREPARATION AND STABILITY OF WORKING REAGENT
This reagent is intended for in vitro quantitative determination of CK-MB in human Reconstitute one tablet of R2 in one vial of R1.
serum. The reconstituted reagent is stable for 8 days at 2-80C.
- Immuno – inhibition methodology Calibrator: Reconstitute the calibrator with 2 mL distilled water and reconstituted
- Linear up to 1000 U/L calibrator is stable for:
- Working Reagent Stable up to 8 days at 2- 80C 24 hrs at 15 to 25oC
- Excellent pack sizes, Convenient for all laboratories 3 Days 2 to 8oC
CLINICAL SIGNIFICANCE 1 Month at -15 to -25oC
CK-MB is an enzyme formed by the association of two subunits from muscle(M) and PRECAUTION
nerve cells (B). CK-MB is usually present in serum at low concentration; it increases To avoid contamination, use clean laboratory materials.
after an acute infarct of myocardium and later descends at normal levels. Also is Avoid direct exposure of working reagent to light.
increased, rarely, in skeletal muscle damage.
Clinical diagnosis should not be made on a single test result; it should integrate clinical SAMPLE
and other laboratory data. Serum (Free of haemolysis)
PRINCIPLE GENERAL SYSTEM PARAMETER
An antibody to the anti CK-M inhibits completely CK-MM and subunit (M) of the CK-
MB. The activity of the non – inhibited CK-B subunit is then assayed by the following OD/300 Sec OD/60 Sec
series of reactions: Mode of Reaction Fix Time Kinetic
CK Slope of reaction Increasing Increasing
Phosphocreatine + ADP ----> Creatine + ATP Wavelength 340 nm 340 nm
HK Temperature 37 0C 37 0C
ATP + Glucose ----- > ADP + Glucose - 6- Phosphate Factor 1651 8254
G6P- DH Linearity 1000 U/L 1000 U/L
G6P+ NADP+ ------------> 6 – Phosphogluconate + NADPH + H+ Blank DI Water DI Water
The rate of NADPH formation, measured photometrically, is proportional to the Delay time 600 sec 180 sec
catalytic concentration of CK –B present in the sample.
No of reading - 3
REAGENT COMPOSITION Delta time 300 sec 60 sec
CK-MB R1 5 x 2.5 mL Reagent volume 1000 µL 1000 µL
Buffer Sample volume 40 µL 40 µL
Imidazol (pH 6.7) 100 mmol/L Cuvette 1 cm light path 1 cm light path
Glucose 20 mmol/L
LABORATORY PROCEDURE
Magnesium acetate 10 mmol/L
Working reagent 1000 µL
EDTA 2mmol/L
Sample 40 µL
CK-MB R2 5 x 2.5 mL
Mix and incubate at 370C for 10 minutes measure the initial absorbance(A1) and again
*Anti CK –M 200 U/L take the readings for 5 minutes(A2). Calculate the difference between absorbance
ADP 2 mmol/L A = (A2-A1), or mix and incubate at 370C for 3 minutes. Read the charge in absorbance
AMP 5mmol/L per minute ( OD/minutes) during 3 minutes.
di-Adenosine-5-pentaphosphate 10 mmol/L CALCULATION
NADP+ 2 mmol/L CK-MB Activity (U/L) = A x 1651
Hexokinase 2500 U/L or
Glucose-6-phosphate dehydrogenase 1500 U/L CK-MB Activity (U/L) = A/Min x 8254
N-acetyl cysteine 20 mmol/L
Creatine Phosphate 30 mmol/L BIBLIOGRAPHY
*Anti CK-M sufficient to inhibit up to 2000 U/L of CK-MM 1. Abbot, B. et al.; Creatinine kinase. Kalpan, A. et al. Clin. Chem. The C.V.Mosby
Co. St.Louis. Toronto Princeton 1984:1112 – 116
CK-MB Calibrator 1 x 2 mL 2. Gerhardt, W., et al.; Creatine K inase B-Subnit activity in serum after
Calibrator concentration is mentioned on vial label immunoinhibition of M-subunit activity.; Clin chem.1979; (25/7): 1274- 1280.
STORAGE AND STABILITY 3. Young, D. S.; Effects of drugs on clinical Lab. Tests, 4th Ed AACC 2001.
4. Burits, A. et al.; Tietz Textbook of Clinical Chemistry, 3rd Ed AACC 1999.
The sealed reagents are stable up to the expiry date stated on the label, when stored 5. Tietz, N. W. et al. Clinical Guide to Laboratory Tests, 3rd Ed AACC 1995.
at 2 - 80C.
LINEARITY
This reagent is linear up to 1000 U/L.
If the concentration is greater than linearity (1000 U/L), dilute the sample with normal
saline and repeat the assay. Multiply result with dilution factor.
NORMAL VALUES
It is recommended that each laboratory should establish its own reference values.
The following value may be used as guide line.
250C 300 C 370C
CK-MB : > 10 U/L > 15 U/L >24 U/L

5
 5 x 2.5 mL
CK-NAC 11206004
INTENDED USE SAMPLE
This reagent is intended for in vitro quantitative determination of Creatine Kinase in Serum (Free of haemolysis)
human serum.
GENERAL SYSTEM PARAMETER
- Optimized IFCC Method
- Linear up to 1000 U/L Mode of Reaction Kinetic
- Working Reagent is stable up to 5 days at 2-80C. Slope of reaction Increasing
- Excellent pack Sizes, Convenient for all laboratories. Wavelength 340 nm
CLINICAL SIGNIFICANCE Temperature 370C
It is mainly found in all muscle (Cardiac & Skeletal) & brain tissues. It plays an Factor 8095
important role in energy storing mechanism of the tissues. It’s iso-enzymes: CK-MB Linearity 1000 U/L
mainly exists in cardiac muscle tissues, CK-MM in skeletal muscle tissues & CK-BB
in brain. Blank Distilled Water
Increased levels are found in myocardial infarction, muscular dystrophy, Delay time 120 sec.
cerebrovascular-disease, pulmonary infarction, electrical shocks & hypothyroidisim. No of reading 3
Decreased levels are, some times seen in early pregnancy, alcohol, liver diseses, RA.
Interval 60 sec
PRINCIPLE Reagent volume 1000 µL
Creatine kinase(CK) catalyses the reversible transfer of a phosphate group from
phosphocreatinine to ADP. This reaction is coupled to those catalyzed by hexokinase Sample volume 20 µL
(HK) and glucose – 6- phosphate dehygrogenase (G6P-DH) Cuvette 1 cm light path
CK LABORATORY PROCEDURE
Phosphocreatine + ADP ----- > Creatine +ATP Working reagent 1000 µL
HK Sample 20 µL
ATP + Glucose ----- > ADP + Glucose – 6- phosphate Mix and incubate at 370C for 2 minutes, measure the change in absorbance per
G6P – DH minute ( OD/min) during 3 minutes.
G6P + NADP+ ------------- > 6- Phosphogluconate + NADPH + H+ CALCULATION
The rate of NADPH formation, measured photometrically, is proportional to the Creatine Kinase Activity (U/L) = ( OD /min.) x 8095
catalytic concentration of CK present in the sample.
BIBLIOGRAPHY
REAGENT COMPOSITION 1. Abbot, B. et al. Creatinine kinase. Kalpan, A. et al.; Clin. Chem. The C.V.Mosby
CREATINE KINASE R1 5 x 2.5 mL Co. St Louis. Toronto Princeton 1984:1112 – 116
Buffer 2. Gerhardt, W. et al. Creatine K inase B-Subnit activity in serum after
Imidazol pH 7.0 100 mmol/L immunoinhibition of M-subunit activity; Clin. chem.1979; (25/7): 1274- 1280.
Glucose 20 mmol/L 3. Young, D. S.; Effects of drugs on clinical Lab. Tests, 4th ed AACC 2001.
4. Burits, A. et al. ; Tietz Textbook of Clinical Chemistry, 3rd ed AACC 1999.
Magnesium acetate 10 mmol/L 6. Tietz, N. W. et al. Clinical Guide to Laboratory Tests, 3rd Ed AACC 1995.
EDTA 2mmol/L
CREATINE KINASE R2 5 x 2.5 mL
Substrate
ADP 2 mmol/L
AMP 5 mmol/L
Di-Adenosine – 5-pentaphosphate 10mmol/L
NADP + 2 mmol/L
Hexokinase 2500 U/L
Glucose -6-phosphate dehydrogenase 1500 U/L
N-acetyl cysteine 20 mmol/L
Creatine Phosphate 30mmol/L
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 1000 U/L
If the concentration is greater than linearity (1000 U/L), dilute the sample with
normal saline and repeat the assay. Multiply the final result with dilution factor.
NORMAL VALUES
It is recommended that each laboratory establish its own reference value.
The following value may be used as guide line.
250C 300C 370C
Men up to : 80 U/L 130 U/L 195 U/L
Women up to : 70 U/L 110 U/L 170 U/L
PREPARATION AND STABILITY OF WORKING REAGENT
Reconstitute one tablet R2 with one vial of R1 .
The reconstituted reagent is stable for 5 days at 2-8 0C.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of working reagent to light.

ADL/V.02/February 2013

6
 4 x 100 mL,4 x 250 mL, 4 x 500 mL
GLUCOSE 11208001, 11208002, 11208003
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of Glucose in serum, Mode of Reaction Fixed time Kinetic
plasma & CSF.
Slope of reaction Increasing
- GOD –PAP methodology
- Linear upto 500 mg/dL Wavelength 505 (500-540 nm)
- Reconstituted stability 90 days at 2-80C Temperature 370C
- No interferences from Bilirubin and Creatinine Standard Concentration 100 mg/dL
CLINICAL SIGNIFICANCE Blank Reagent Blank
Glucose is a major carbohydrate present in the blood & serves as a primary source of Linearity 500 mg/dL
energy. It is usually obtained from ingested starch & sugar. The glucose concentration Delay 30 sec.
is normally maintained at constant level. Excessive glucose is stored as inactive
glycogen mainly in the liver & little in the muscles. Interval 60 sec
Elevated blood glucose levels are found in diabetes mellitus, hyperthyroidism, Sample volume 10 µL
hyperadrenalism & certain liver diseases. Reagent volume 1000 µL
Decreased levels are found in Insulinoma, hypothyroidism, hypopituitarism.
Cuvette 1 cm light path
PRINCIPLE
CALCULATION FOR FIXED TIME
Enzymatic colorimetric determination of glucose according to the following reaction.
Absorbance of Sample
Glucose Oxidase
Glucose conc (mg/dL)= ----------------------------------- x 100
Glucose+ O2 ------------------> Gluconic acid + H2O2
Absorbance of standard
Peroxidase
2H2O2+phenol + 4-Aminoantipyrine --------------- > red Quinonimine + 4H2O GENERAL SYSTEM PARAMETER FOR ENDPOINT
REAGENT COMPOSITION Mode of Reaction End point
GLUCOSE R1 4x100mL / 4x250mL / 4x500mL Slope of reaction Increasing
Phosphate buffer, (pH 7.40) 100 mmol/L Wavelength 505 nm
Phenol 10 mmol/L Temperature 370C
GLUCOSE R2 4x100mL / 4x250mL / 4x500mL Standard Concentration 100 mg/dL
Glucose Oxidase > 10000 U/L
Blank Reagent Blank
Peroxidase > 600U/L
4-Aminoantipyrine 270mmol/L Linearity 500 mg/dL
GLUCOSE STANDARD 1x4mL / 2x4mL Incubation time 10 min
Glucose standard concentration 100 mg/dL Sample volume 10 µL
Note : For 4x500 mL and 4x250mL packs, Buffer will be provided separately Reagent volume 1000 µL
STORAGE AND STABILITY Cuvette 1 cm light path
The sealed reagents are stable upto the expiry date stated on the label, when stored LABORATORY PROCEDURE
at 2 - 80C. Blank Standard Sample
LINEARITY Working reagent 1000 µL 1000 µL 1000 µL
This reagent is linear upto 500mg/dL Standard - 10 µL -
If the concentration is greater than linearity (500 mg/dL), dilute the sample with normal Sample - - 10 µL
saline and repeat the assay. Multiply the result with dilution factor. Mix and incubate for 10 minutes at 37 0C. Measure the change in absorbance of
standard and sample against reagent blank.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line. CALCULATION FOR END POINT
Serum / Plasma : 70-105 mg/dL Absorbance of Sample
CSF : 50 -70 mg/dL Glucose Conc. (mg/dL) = ------------------------------ x 100
PREPARATION AND STABILITY OF WORKING REAGENT Absorbance of standard
Dissolve Reagent 2(R2 )with the volume of Reagent 1 (R1) indicated on the label. BIBLIOGRAPHY
The reconstituted reagent is stable for 90 days at 2-80c. Trinder, P.; Ann. Clin., Biochem. 6, (1969) 24
NOTE: Discard the working reagent if the blank absorbance exceeds 0.08.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of working reagent to light.
SAMPLE
Serum / plasma (free of haemolysis) / CSF.

ADL/V.02/February 2013

7
 5x 20 mL,4x 50 mL,
SGOT 11213005, 11213003
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of SGOT in serum or Mode of Reaction Kinetic
plasma.
Slope of reaction Decreasing
- Proven IFCC methodology
- Linear up to 350 U/L Wavelength 340 nm
- Reconstituted reagent stable up to 30 days at 2-80C Temperature 370C
CLINICAL SIGNIFICANCE Factor 1768
It is present in most of the tissues. Especially in cardiac muscle, liver cells, skeletal Linearity 350 U/L
muscle & kidneys. Injury to these tissues results in the release of the enzyme in blood Blank DI Water
stream.
Delay 60 sec.
Increased levels are found in myocardial infarction. The duration & extent of increase
is related to the infract. GOT determination is of considerable value to differentiate No of reading 3
myocardial infraction from other cardiac disorders. Interval 60 sec
Increased levels are also found in various types of liver disease, skeletal muscle trauma Sample volume 100 µL
& in renal diseases.
Decreased levels may be found in pregnancy, Beri-Beri & Diabetic ketoacidosis. Reagent volume 1000 µL
Cuvette 1 cm light path
PRINCIPLE
LABORATORY PROCEDURE
Kinetic determination of Aspartate Aminotrasferase (AST) based upon the following
reaction. Working reagent 1000 µL
AST/SGOT Sample 100 µL
L- Aspartate + alpha - ketoglutarate ------ > Oxaloacetate + L-Glutamate. Mix and incubate at 370C for 1 minute. Measure the change in absorbance per minute
( OD/min) during 3 minutes.
MDH
Oxaloacetate + NADH + H+ ------ > L- Malate + NAD+ CALCULATION
AST : Aspartate aminotransferase. SGOT activity (U/L) = ( OD/min) x 1768
MDH : Malate dehydrogenase. BIBLIOGRAPHY
REAGENT COMPOSITION Expert panel on enzyme of the IFCC; Clin. Chim. Acta, 70(1976) F 19.
SGOT R1 2 x 53 mL / 4 x 50 mL
Tris Buffer (pH 7.8) 88 mmol/L
L-Aspartate 260 mmol/L
SGOT R2 5x 20 mL / 4x 50 mL
MDH > 600 U/L
LDH > 900 U/L
NADH 0.20 mmol/L
a -ketoglutarate 12 mmol/L
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 350 U/L.
If the concentration is greater than linearity (350 U/L), dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
REFERENCE RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Females upto 31U/L at 37o CS
Males upto 35U/L at 37o C
PREPARATION AND STABILITY OF WORKING REAGENT
Reconstitute the reagent 2 (R2 ) with the volume of reagent 1 (R1) mentioned on the
vial label. The reconstituted reagent is stable for 30 days at 2-80C.
NOTE: Discard the working reagent if the blank absorbance is less than 1.00 at 340
nm.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of working reagent to light.
SAMPLE
Serum / plasma (free of haemolysis)

ADL/V.02/February 2013

8
 5 x 20 mL, 4 x 50 mL
SGPT 11214005,11214003
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of SGPT in serum or Mode of Reaction Kinetic
plasma.
Slope of reaction Decreasing
- IFCC recommended methodology
- Linear up to 350 U/L Wavelength 340 nm
- Reconstituted reagent stable up to 50 days at 2 - 80C Temperature 370C
CLINICAL SIGNIFICANCE Factor 1768
It is present in most of the tissues, but mainly found in the liver. Increased levels are Blank DI Water
found in hepatitis, cirrhosis, obstructive jaundice & other hepatic disease. SGPT activity Linearity 350 U/L
is markedly elevated even before clinical signs of jaundice become apparent in disease
associated with hepatic necrosis. Slight elevations are also found in myocardial Delay 60 sec.
infraction. No of reading 3
PRINCIPLE Interval 60 sec
Kinetic determination of Alanine Aminotransferase (ALAT) according to the following Sample volume 100 µL
reaction. Reagent volume 1000 µL
ALT
Cuvette 1 cm light path
L-Alanine + alpha-ketoglutarate ----- > Pyruvate +L-Glutamate
LDH LABORATORY PROCEDURE
+
Pyruvate +NADH+ H ----- > L-Lactate +NAD+
Working reagent 1000 µL
ALT – Alanine aminotranferase Sample 100 µL
LDH - Lactate dehydrogenase
Mix and incubate at 370C for 1 minute. Measure the change in absorbance per minute
REAGENT COMPOSITION ( OD/min) during 3 minutes.
SGPT R1 2 x 53 mL/ 4 x 50 mL
CALCULATION
Tris buffer (pH 7.5) 110 mmol/L
SGPT activity (U/L) = ( OD/min) x 1768
L-Alanine 550 mmol/L
BIBLIOGRAPHY
SGPT R2 5 x 20 mL/ 4 x 50 mL
Expert panel on enzyme of the IFCC; Clin. Chim. Acta, 70 (1976) F19.
LDH > 200 U/L
NADH 0.20 mmol/L
a-ketoglutarate 16 mmol/L
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 350 U/L .
If the concentration is greater than linearity (350 U/L), dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum up to : 49 U/L
PREPARATION AND STABILITY OF WORKING REAGENT
Reconstitute the Reagent 2 (R2) with the volume of Reagent1 (R1) mentioned on the
vial label. The reconstituted reagent is stable for 50 days at 2-80C.
NOTE: Discard the working reagent if the blank absorbance is less than 1.00 at 340
nm.
PRECAUTION
To avoid contamination use clean laboratory wares.
Avoid direct exposure of working reagent to light.
SAMPLE
Serum / plasma (free of haemolysis)

ADL/V.02/February 2013

9
 5 x 20 mL, 4 x 50 mL
TRIGLYCERIDES 11215002, 11215003
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of triglycerides in serum Mode of Reaction End Point
or plasma.
Slope of reaction Increasing
- Proven GPO-POD methodology
- Linear up to 1000 mg/dL Wavelength I 505 nm (492-550 nm)
- Extended stability, reconstituted reagent is stable up to 42 days at 2-80 C Wavelength II 630 nm
CLINICAL SIGNIFICANCE Temperature 370C
Triglycerides are simple lipids, formed in the liver by glycerol & fatty acids. They are Standard Concentration 200 mg/dL
transported by VLDL, LDL & constitute about 95% of fat, stored as source of energy Linearity 1000 mg/dL
in the tissue & plasma. Increased levels are found in hyperlipidemias, diabetes,
nephrotic syndrome & hypothyroidism. Increased levels are risk factor for Blank Reagent
arteriosclerotic coronary disease, peripheral vascular disease, acute pancreatitis & Incubation time 5 min
hyperlipoproteinaemia. Decreased levels are found in malnutrition & hyperthyroidism. Sample volume 10 µL
PRINCIPLE Reagent volume 1000 µL
Enzymatic determination of triglyceride is based on the following reactions: Cuvette 1 cm light path
LPL
TGL+H2O ---- >Glycerol + Fatty acid LABORATORY PROCEDURE
GK Blank Standard Sample
Glycerol + ATP ---- > Glycerol-3-phosphate + ADP Working Reagent 1000 µL 1000 µL 1000 µL
Mg++
Standard - 10 µL -
GPO Sample - - 10 µL
Glycerol-3-phosphate+O2------ > Dihydroxyacetone phosphate +H2O2 Mix and incubate for 5 minutes at 370C. Measure the change in absorbance of
POD standard and sample against reagent blank.
2H2O2+4-Aminoantipyrine+p-Chlorophenol ------ > Red Quinone+4H2O
GPO = Glycereol-3-phosphate Oxidase CALCULATION
LPL = Lipoprotein Lipase Absorbance of sample
GK = Glycerol Kinase Triglycerides Con. (mg/dL) = ------------------------------ x 200 mg/dL
Absorbance of standard
REAGENT COMPOSITION
BIBLIOGRAPHY
TRIGLYCERIDES R1 2 x 53 mL / 4 x 50 mL
1. Buccolo, G., David, M.; Clin.Chem., 19(1973) 476
Pipes –buffer (pH 7.00) 50 mmol/L 2. Wener, M., Gabrielson, D. G., Eastman, G.; Clin Chem 21 (1981) 268
p-Chlorophenol 5.3 mmol/L 3. Annoni, G., Bottasso, B. M., Ciaci, D., Donato, M. F., Tripoli, A., Lamb, J.; J. Res.
Magnesium salt 15 mmol/L Lab, Med., 9 (1982) 115
TRIGLYCERIDES R2 5 x 20 mL / 4 x 50 mL
Lipoprotein lipase >1100 U/L
Glycerol Kinase > 800 U/L
Glycerol -3-phosphate oxidase > 5000 U/L
Peroxidase 350U/L
4-Amino antipyrine 0.7 mmol/L / 0.3 mmol/L
TRIGLYCERIDES STANDARD 1 x 4 mL
Triglycerides standard concentration 200mg/dL
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 1000 mg/dL.
If the concentration is greater than linearity (1000 mg/dL), dilute the sample with
normal saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Normal Value 65-165 mg/dL
PREPARATION AND STABILITY OF WORKING REAGENT
Reconstitute the Reagent 2 (R2) with the volume of Reagent 1 (R1) indicated on the
label.
Working reagent is stable for 42 days at 2-80C.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of working reagent to light.
SAMPLE
Serum / plasma (free of haemolysis)

ADL/V.02/February 2013

10
 200 mL
UREA - B 11216001
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of urea in serum, plasma Mode of Reaction End point
& urine.
Slope of reaction Increasing
- Modified Berthelot methodology
- Linear up to 200 mg/dL Wavelength 600 nm (580-650 nm)
- Reconstituted reagent stability for 21 days at 2-80C. Temperature 370C
CLINICAL SIGNIFICANCE Standard Concentration 40 mg/dL
Proteins cannot be stored in human body, so excess should be broken down. Amino Linearity 200 mg/dL
acids which from the components of proteins, break down to give ammonia. This is Blank Reagent
toxic & so through a series of chemical reactions (urea cycle) non toxic urea is
produced & this is released into the blood which is filtered in the kidney & excreted Sample volume 10 µL
in the urine. Reagent volume 1000 µL + 1000 µL
Elevated levels are seen during increased protein in breakdown, dehydration, vomiting, Incubation time 5+5 min
diarrhea. Also seen in any kind of renal disorder like Glomerular nephritis, chronic
nephritis & Nephritic syndrome. Cuvette 1 cm light path
Decreased levels are found in liver failure & pregnancy LABORATORY PROCEDURE
PRINCIPLE Blank Standard Sample
Enzymatic determination of Urea according to the following reaction. Working reagent 1000 µL 1000 µL 1000 µL
Urease
Standard - 10 µL -
Urea + H2O ----------> 2NH3 + CO2
Nitroprusside Sample - - 10 µL
NH3 + salicylate ------------------> 2.2-Dicarboxy Indophenol Mix and incubate for 5 minutes at 370C then add.
Hypochlorite
Colour Reagent 1000 µL 1000 µL 1000 µL
REAGENT COMPOSITION
Mix and incubate for 5 minutes at 370C then add.
UREA B COLOUR REAGENT R1 2 x 53 mL
Sodium Salicylate 80 mmol/L DI Water 1000 µL 1000µL 1000 µL
Sodium Nitroprusside 4 mmol/L Mix well & measure the absorbance of sample and the standard against the reagent
Sodium Hypochlorite 45 mg /dL blank.
UREA B R2 10 x 10 mL CALCULATION
Phosphate buffer, (pH 6.9) 60 mmol/L Absorbance of sample
Urease 20 KU/L Urea Con. (mg/dL) = ---------------------------- X 40
UREA B STANDARD 1 x 4 mL Absorbance of Standard
Urea –B Standard concentration 40 mg/dL BIBLIOGRAPHY
STORAGE AND STABILITY 1. Wheatherburn M.W., Anal. Chem., 1967; 39;971
The sealed reagents are stable up to the expiry date stated on the label, when stored 2. Searcy, R.L., Reardon, J.E., Foreman, J.A.; Amer, J.Med, Tech., 1967; 33, 15-20
at 2 - 80C. 3. Henry, R. J.; Clin. Chem. Principle and Techniques, Harper & Row, New York,
1963.P.268
LINEARITY
This reagent is linear up to 200 mg/dL.
If the concentration is greater than linearity (200 mg/dL), dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum : 10-55 mg/dL
Urine : 20-35 gm/24 hrs
PREPARATION AND STABILITY OF WORKING REAGENT
Reconstitute 1 vial of reagent 2 (R2) with the volume of DI water as indicated on the
vial label.
Working reagent is stable for 21 days at 2-80C.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of working reagent to light.
SAMPLE
Serum / plasma (free of haemolysis) / Urine (1/100 Diluted)

11
 4 x 50 mL, 4 x 100 mL
UREA U.V 11217001, 11217002
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of urea in serum, Mode of Reaction Fixed Time
plasma & urine.
Slope of reaction Decreasing
- Urease / GLDH methodology
- Linearity Wavelength 340
Urea : 500 mg/dL Temperature 370C
BUN : 235 mg/dL Standard Concentration 50 mg/dL
- Working reagent stability is 42 days at 2-80C. Linearity 500 mg/dL
CLINICAL SIGNIFICANCE Blank DI Water
Proteins cannot be stored in human body, so excess should be broken down. Amino Delay time 30 sec
acids which from the components of proteins, break down to give ammonia. This
is toxic & so through a series of chemical reactions (urea cycle) non toxic urea is Interval 60 sec
produced & this is released into the blood which is filtered in the kidney & excreted Sample volume 10 µL
in the urine. Reagent volume 1000 µL
Elevated levels are seen during increased protein breakdown, dehydration, vomiting,
diarrhea. Also seen in any kind of renal disorder like Glomerular nephritis, Chronic Cuvette 1 cm light path
nephritis & Nephritic syndrome. LABORATORY PROCEDURE
Decreased levels are found in liver failure & pregnancy. Standard Sample
PRINCIPLE Working reagent 1000µL 1000 µL
Urease
Urea + H2O ---------- > 2NH3 + CO2 Standard 10 µL -
GLDH Sample - 10 µL
2 NH3+2a- ketoglutarate + 2NADH --------- > 2L-Glutamate+2NAD+ + 2H2O
Mix and read the optical density (T 1) 30 seconds after the sample or standard
REAGENT COMPOSITION addition. Exactly 60 seconds after the first reading take second reading (T2).
UREA U.V. R1 4 x 50 mL / 4 x 100 mL CALCULATION
Buffer (pH 7.55) 75 mmol/L (T1 –T2)of Sample
UREA U.V. R2 4 x 50 mL / 4 x 100 mL Urea Conc. (mg/dL) = ------------------------ x 50
ADP 0.66 mmol/L (T1-T2) of standard
GLDH >1000U/L
Urease > 30000 U/L (T1 –T2)of Sample
NADH 0.32 mmol/L Urea BUN Conc. (mg/dL) = ------------------------ x 23.4
a-ketoglutarate 7.5 mmol/L (T1-T2) of standard
UREA U.V. STANDARD 1 x 4 mL BIBLIOGRAPHY
Standard concentration for Urea 50 mg/dL 1. Talke, H. and Schubert, G. E.; Kiln-Wocchsr 19; 43: 174
Standard concentration for BUN 23.4 mg/dL 2. Thomas, L.; Labor and Diagnose, 1. Auflage, S. 346
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 500 mg/dL.
If the concentration is greater than linearity (500 mg/dL), dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Urea Urea – N
Sreum : 10-50 mg/dL 4.7 – 23 mg/dL
Urine /24 hr :20-36 gm/L 9.4-16.9 gm/L
PREPARATION AND STABILITY OF WORKING REAGENT
Dissolve Reagent 2 (R2) with the volume of Reagent 1 (R1) indicated on the label.
Working reagent is stable for 42 days at 2-80C.
Note: Discard the working reagent if the blank absorbance is less than 1.0 at 340 nm.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of working reagent to light.
SAMPLE
Serum / plasma (free of haemolysis)
Urine (1/100 diluted).
Do not use anticoagulants containing fluoride or ammonium ions.

ADL/V.02/February 2013

12
 5x20 mL, 4 x 50 mL
URIC ACID 11218002, 11218003
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for invitro quantitative determination of Uric acid in serum, Mode of Reaction End point
plasma & urine.
Slope of reaction Increasing
- Uricase - PAP methodology
- Linear up to 25 mg/dL Wavelength I 505 nm (500 - 550)
- Reconstituted reagent stability up to 30 days at 2-80C Wavelength II 630 nm
- Fast incubation, just 5 minutes at 370C Temperature 370C
CLINICAL SIGNIFICANCE Standard Concentration 6 mg/dL
Uric acid is the end product of purine metabolism. Uric acid is excreted by the kidneys. Linearity 25 mg/dL
Increased levels are found in gout, arthritis, impaired renal functions & starvation. Blank Reagent
Decreased levels are found in yellow atrophy of the liver, Wilson’s disease ,& Fanconis
syndrom. Sample volume 20 µL
PRINCIPLE Reagent volume 1000 µL
Enzymatic determination of Uric acid according to the following reactions. Incubation time 5 minutes
Uricase Cuvette 1 cm light path
Uric acid + 2H2O+O2 ----------> Allantoin +CO2 +H2O2 LABORATORY PROCEDURE
Peroxidase
Blank Standard Sample
2H2O2 + 4 -Aminoantipyrine +DHBS -------------> Red quinone + H2O+ HCL
Working Reagent 1000 µL 1000 µL 1000 µL
DHBS = 3,5-Dichloro -2-Hydroxybenzenesulfonic acid. Standard - 20 µL -
REAGENT COMPOSITION Sample - - 20 µL
URIC ACID R1 2 x 53 mL / 4 x 50 m L
Mix and incubate 5 min. at 370C. Measure absorbance of sample and standard against
Phosphate Buffer (pH 7.5) 100 mmol/L the reagent blank.
DHBS 2 mmol/L
URIC ACID R2 5 x 20 mL / 4 x 50 mL CALCULATION
4 – Aminoantipyrine > 0.23mmol/L Absorbance of Sample
Peroxidase > 660 U/L Uric Acid Con. (mg/dL) = ------------------------------ x6
Uricase > 60 U/L Absorbance of Standard
URIC ACID STANDARD 1 x 4 mL BIBLIOGRAPHY
Uric acid standard concentration 6 mg/dL 1.Trivdi R.C., Revbar L., Berka, E., Strong L.,Clin. Chem. 24 (1978) 1908
2. Text Book of medical Laboratory Technology, sood
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 25 mg/dL.
If the concentration is greater than linearity (25 mg/dL), dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum / Plasma
Males : 3.4 - 7.0 mg/dL
Females : 2.5 - 6.0 mg/dL
Children : 2.5 - 5.5 mg/dL
Urine : 250 - 750 mg/ 24 hr urine
PREPARATION AND STABILITY OF WORKING REAGENT
Reconstitute the reagent 2 (R2) with the volume of Reagent 1 (R1) indicated on the
vial label.
Working reagent is stable for 30 days at 2-80C.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of working reagent to light.
SAMPLE
Serum / plasma (free of haemolysis) / Urine (1/10 diluted with distilled water).

ADL/V.02/February 2013

13
 2 x 10 mL, 2 x 30 mL, 2 x 50 mL
ALKALINE PHOSPHATASE (S.L) 11401001, 11401005, 11401003
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of Alkaline Phosphatase Mode of Reaction Kinetic
in serum or plasma.
Slope of reaction Increasing
- DGKC – SCE recommended procedure
- Linear upto 700 U/L Wavelength 405 nm
- Working reagent can be prepared as per requirement Temperature 370C
- Pack sizes to suit all types of laboratories Factor 2750
CLINICAL SIGNIFICANCE Blank DI water
Alkaline phosphatase (ALP) is widely distributed throughout the body, but clinically Linearity 700 U/L
important one for diagnostic reasons are in bone, liver, placenta & intestine. Growing Delay time 60 sec
bone is associated with the release of ALP and so in childhood the level of ALP is
around 3 times of that of adult. During pregnancy in 2nd & 3rd trimester the enzyme No of readings 3
rises considerably due to placenta releasing ALP. It can be used to examine placental Interval 60 sec
function.
Sample volume 20 µL
Elevated levels are seen in bone diseases, e.g. pagets disease, rickets, osteoblastic
metastatic & in obstructive disease of biliary tract. Reagent volume 1000 µL
Decreased levels are rarely seen. e.g. in Vitamin A resistant rickets. Cuvette 1 cm light path
PRINCIPLE
Kinetic determination of ALP according to the following reaction LABORATORY PROCEDURE
ALP Working reagent 1000 µL
Para-nitrophenyl phosphate + H2O ----- > p-nitrophenol+Inorgnic Sample 20 µL
phosphate Mix and incubate at 37 0C for one minute. Measure the change in absorbance per
ALP = Alkaline Phosphatase minute ( OD/min) during 3 minutes.

REAGENT COMPOSITION CALCULATION

ALP Activity (U/L) = ( OD / min.) x 2750
ALKALINE PHOSPHATASE(S.L) R1 2 x 8 mL /2 x 24 mL / 2 x 40 mL
Diethanolamine Buffer (pH 10.2) 125 mmol/L BIBLIOGRAPHY
Magnesium Chloride 0.625 mmol/L 1. Schlebusch, H., et al.; Dtsch .Med. Wschr. 99, 765 (1974)
2. Z. Klin. Chem. Klin Biochem. 8,658 (1980) 10, 182 (1972)
ALKALINE PHOSPHATASE (S.L) R2 2 x 2 mL/2 x 6 mL / 2 x 10 mL
P-Nitrophenyl phosphate 50 mmol /L
STORAGE AND STABILITY
The sealed reagents are stable upto the expiry date stated on the label, when stored
at 2-80C.
LINEARITY
The reagent is linear, upto 700 U/L.
If the concentration is greater than linearity (700 U/L), dilute the sample with normal
saline & repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values. The
following value may be used as guide line.
Women: 64 - 306 U/L
Men : 80 - 306 U/L
Children up to 15 yrs: < 644 U/L
Children up to 17 yrs: < 483 U/L
PREPARATION AND STABILITY OF WORKING REAGENT
Mix 4 volume of Reagent 1 (R1) with 1 volume Reagent 2 (R2)
The working reagent is stable for 30 days at 2-80C.
Note : Discard the working reagent if the blank absorbance exceeds 1.00 at 405 nm.
PRECAUTION
To avoid contamination, use clean laboratory wares. Avoid direct exposure of
working reagent to light.
SAMPLE
Serum / plasma (free of haemolysis)

ADL/V.02/JAN 2013

14
 4 x 5 mL, 4 x 10 mL
AMYLASE (S.L) 11402001, 11402002
Blank DI water
INTENDED USE
Delay time 60 sec
This reagent is intended for in vitro quantitative determination of amylase in serum,
plasma & urine. No.of readings 3
- CNPG3 methodology Interval 60 sec
- Linear upto 2000 U/L Sample volume 25 µL
CLINICAL SIGNIFICANCE Reagent volume 1000 µL
Amylase occurs in the salivary glands, fallopian tubes & in pancreas. Cuvette 1 cm light path
alpha-amylase is secreted by the pancreas from where it enters the duodenum, through LABORATORY PROCEDURE
the pancreatic duct. Any obstruction to these ducts causes alpha-amylase enzyme to
enter the blood stream. Reagent (R1) 1000 µL
Elevated levels seen in acute pancreatitis, peptic ulcers, biliary disease, parotitis & other Sample 25 µL
0
intestinal obstructions. Mix and incubate for 1 min. at 37 C . Measure the change in absorbance per minute
Decreased levels are seen in chronic pancreatic disorders having pancreatic cell ( OD/min) during 3 minutes.
destruction. CALCULATION
PRINCIPLE alpha-Amylase activity (U/L) = ( OD/ min.) x 3178
Amylase BIBLIOGRAPHY
5CNPG3 ------------> 3 CNP +2CNPG2+3 Maltotriose + 2 Glucose. 1. Junge, W., et al.; Clin. Biochem. 22, 109(1989)
CNP = 2-Chloro-4-nitrophenol 2. Hohenwallnern, W.; J.Clin. chem. Clin. Biochem. 27,97(1989)
CNP-G2= 2-chloro -4-nitrophenyl-a-maltoside
REAGENT COMPOSITION
ALPHA AMYLASE (S.L) R14x 5 mL / 4 x 10 mL
MES Buffer (pH6.0) 50 mmol/L
CNPG3 2.27 mmol/L
Calcium chloride 60 mmol/L
Sodium chloride 70 mmol/L
Activator 900 mmol/L
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2-80C.
LINEARITY
The reagent is linear, up to 2000 U/L.
If the concentration is greater than linearity (2000 U/L), dilute the sample with normal
saline & repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values. The
following value may be used as guide line.
Serum / plasma : 25 - 86 U/L
Urine : < 470 U/L
PREPARATION AND STABILITY OF REAGENT
The reagent is ready to use.
PRECAUTION
To avoid contamination, use clean laboratory wares. Avoid direct exposure of reagent
to light.
This reagent is very sensitive to external contamination, ie Saliva, Sweat etc which
contains alpha-amylase. Handle with gloves & keep vial tightly sealed after use.
Discard reagent if it turns cloudy.
SAMPLE
Fresh serum / plasma (free of haemolysis) / Urine (1/3 diluted)
GENERAL SYSTEM PARAMETER
Mode of Reaction Kinetic
Slope of reaction Increasing
Wavelength 405 nm
Temperature 370C
Factor 3178
Linearity 2000 U/L

15
 5 x 25 mL, 5 x 100 mL, 4 x 250 mL
CHOLESTEROL (S.L) 11403002, 11403003, 11403007
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of Cholesterol in serum Mode of Reaction End point
or plasma.
Slope of reaction Increasing
- CHOD-PAP methodology
- Linear upto 600 mg/dL Wavelength I 505 (492 -550) nm
- Contains LCF (Lipaemic clearing factor) which minimizes rerun Wavelength II 630 nm
CLINICAL SIGNIFICANCE Temperature 370C
It is the main lipid found in the blood, bile & brain tissues. It is also one of the most Standard Concentration 200 mg/dL
important steroids of the body & is a precursor of many steroid hormones. Two thirds Blank Reagent
of cholesterol present in the blood is esterified. The liver metabolizes the cholesterol
& it is transported in the blood stream by lipoproteins. Linearity 600 mg/dL
Increased levels are found in hypercholesterolaemia, hyperlipidaemia, hypothyroidism, Incubation time 5 min
uncontrolled diabetes, nephritic syndrome & cirrhosis. Sample volume 10 µL
Decreased levels are found in malabsorption, malnutrition, hyperthyroidism, anaemia Reagent volume 1000 µL
& liver diseases.
Cuvette 1 cm light path
PRINCIPLE LABORATORY PROCEDURE
Enzymatic colorimetric determination of total cholesterol according to the following Blank Standard Sample
reactions.
Working Reagent 1000 µL 1000 µL 1000 µL
Cholesterol esterase
Standard - 10 µL -
Cholesterol ester +H2O --------------------------> Cholesterol + fatty acids
Sample - - 10 µL
Cholesterol Oxidase 0
Mix,and incubate for 5 min.at 37 C. Measure the absorbance of sample and standard
Cholesterol + O2 --------------------------> 4-Cholesten-3- one + H2O2 against reagent blank.
Peroxidase
2H2O2 +Phenol+4-Aminoantipyrine --------------> - Red quinone + 4H2O CALCULATION

REAGENT COMPOSITION Cholesterol Conc. (mg/dL) = Absorbance of sample x 200

CHOLESTEROL (S.L) R1 5 x 25 mL / 5 x 100 mL / 4 x 250 mL Absorbance of standard
Pipes buffer (pH 6.70) 50 mmol/L BIBLIOGRAPHY
Phenol 24 mmol/L Allain, C.C., et al.; Clin.Chem 20 (1974), 470
Sodium Cholate 0.5 mmol/L
4-aminoantipyrine 0.5 mmol/L
Cholesterol Esterase > 180 U/L
Cholesterol Oxidase > 200 U/L
Peroxidase > 1000 U/L
CHOLESTEROL STANDARD 1 x 4 mL
Cholesterol std. concentration 200 mg/dL
STORAGE AND STABILITY
The sealed reagents are stable upto the expiry date stated on the label when stored at
2- 80C.
LINEARITY
This reagent is linear upto 600 mg/dL.
If the concentration is greater than linearity (600 mg/dL), dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum / Plasma : 150 – 220 mg/dL
PREPARATION AND STABILITY OF WORKING REAGENT
The reagent is ready to use.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
SAMPLE
Serum / Plasma (free of haemolysis).

ADL/V.02/JAN 2013

16
 2 x 10 mL
CHOLINESTERASE(S.L) 11419002
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of cholinesterase in Mode of Reaction Kinetic
serum or plasma.
Slope of reaction Decreasing
- New DGKC method
- Ready to use liquid stable reagents Wavelength 405 nm
- High linearity and high sensitivity Temperature 370C
CLINICAL SIGNIFICANCE Factor 22653
Cholinesterase also known as acetyl-cholinesterase and is found mainly in the nerve Linearity 41400 U/L
endings and the grey matter of brain. It hydrolyses acetylcholine, released at the nerve Blank DI Water
endings to mediate transmission of impulses. A similar enzyme acyl choline
acylhydrolase also known as pseudocholinesterase is present in the serum, brain, Delay 30 sec
heart, liver and pancreas but its biological role is unknown. No of reading 3
Cholinesterase levels in serum are useful as a test of liver function and as an indicator Interval 30 sec
of possible insecticide poisoning. Among the organic phosphorous compounds that
inhibit cholinesterase activity are mainly insectisides such as Parathion, Sarin and Sample volume 50 µL
Tetraethylpyrophosphate. During poisoning the level of enzymes decreases as its Reagent volume 1000 µL
activity is inhibited. Cuvette 1 cm light path
PRINCIPLE
Cholinesterase catalyses the hydrolysis of butyrylthiocholine substrate forming LABORATORY PROCEDURE
butyrate and thiocholine. Working reagent 1000 µL
CHE Sample 50 µL
butyrylthiocholine+H2O`------- > Thiocholine + Butyrate Mix and incubate at 370C for 30 seconds . Measure the change in absorbance per
Thiocholine reduces hexacyanoferrate(3) to hexacyanoferrate(2) 30 seconds during 90 seconds.
Thiocholine + hexacyanoferrate(3)---------> Hexacyanoferrate(2) CALCULATION
The decrease of absorbance is followed at 405 nm and is proportional to the activity Cholinesterase activity (U/L) = ( OD/ 30 sec) x 22653
of cholinesterase in the sample.
Unit conversion : U/L x 0.01667 = µ katal/L
REAGENT COMPOSITION
INTERFERENCES
CHOLINESTERASE(S.L) R1 2 x 8 mL Test will not be affected by
Pyrophosphate buffer, (pH 7.6) 75 mmol/L Bilirubin upto20 mg/dL
Hexa cyanoferrate(3) 2 mmol/L Hemoglobin upto500 mg/dL
CHOLINESTERASE (S.L)R2 2 x 2 mL Triglycerides upto1000 mg/dL
Butyrylthiocholine 15 mmol / L BIBLIOGRAPHY
STORAGE AND STABILITY 1. Eur. J. Clin. Chem; Clin. Biochem 30, 163(1992)
The sealed reagents are stable upto the expiry date stated on the label, when stored 2. Tietz, Text book of Clinical chemistry, 2nd Edition, Brutis, Ashwood (1994)
at 2- 80C. 3. Knedel, M and Bottger, R; Klin. Wschr. 1967; 45;30

LINEARITY
This reagent is linear upto 41400 U/L.
The lower detection limit is 50 U/L.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Females : 3930 – 10800 U/L
Males : 4620 – 11500 U/L
PREPARATION AND STABILITY OF WORKING REAGENT
Mix 4 parts of R1 with one part of R2 to prepare working reagent.
The working reagent is stable only for 3 hours at 15 -250C.
PRECAUTION
To avoid contamination, use clean laboratory wares. Use clean, dry disposable pipette
tips for dispensing. Close reagent bottles immediately after use. Avoid direct exposure
of working reagent to light.
SAMPLE
Use fresh serum / plasma.
Do not use sodium fluoride as an anticoagulant because it inhibits cholinesterase.
Samples are stable for 15 days at 2-80C.

ADL/V.02/February 2013

17
 2 x 12.5 mL, 2 x 20 mL
CK-MB (S.L) 11405007, 11405002
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of CK-MB in human Mode of Reaction Kinetic
serum or plasma.
Slope of reaction Increasing
- Immuno – inhibition methodology
- Linear up to 600 U/L Wavelength 340 nm
- Convenient pack sizes for all laboratories Temperature 370C
CLINICAL SIGNIFICANCE Factor 8254
CK – MB levels increases significantly 4-6 hours following a myocardial infarction & Linearity 600 U/L
peak at around 12 to 24 hours after the infarct. The levels return to normal in case Blank DI Water
of no further myocardial damage after 24 - 48 hours. Hence the increased levels of
CK-MB along with elevated levels of CK-NAC is a good indicator of myocardial infarction. Delay 100 sec
No of reading 5
PRINCIPLE
The procedure involves measurement of CK-activity in the presence of an antibody Interval 60 sec
to CK-M monomer. This antibody completely inhibits the activity of CK-MM & half Sample volume 40 µL
of the activity of CK-MB, while not affecting the B subunit activity of CK-MB & Reagent volume 1000 µL
CK –BB. Then we use CK method to quantitatively determine CK-B activity. The CK-MB
activity is obtained by multiplying the CK-B activity by two. Cuvette 1 cm light path
REAGENT COMPOSITION
LABORATORY PROCEDURE
CK-MB (S.L) R1 2 x 10mL / 2 x 16 mL
Working reagent 1000 µL
Imidazole (pH 6.7) 125 mmol/L
Sample 40 µL
D-Glucose 25 mmol/L
Mix and incubate at 370C for100 seconds. Read the change in absorbance per minute
N-Acetyl –L- Cysteine 25 mmol/L ( OD/ minute) during 5 minutes.
Magnesium acetate 12.5 mmol/L
NADP 2.52 mmol/L CALCULATION
EDTA 2.02 mmol/L CK-MB Activity (U/L) = OD/Min x 8254
Hexokinase > 6800 U/L BIBLIOGRAPHY
Anti human polyclonal CK-M antibody (sheep) sufficient to inhibit up to 2000 U/L 1. DGKC, J.Clin. Chem Clin. Bioch. 15, 255(1977)
of CK-MM. 2. Di. Witt, C Trendelendurg, J. Clin. Chem, Clin Bioch. 20, 235 (1982)
CK-MB (S.L) R2 2 x 2.5 mL / 2 x 4 mL
Creatine phosphate 250 mmol/L
ADP 15.2mmol/L
AMP 25 mmol/L
Diadenosine pentaphosphate 103 mmol/L
G-6-PDH > 8800 U/L
STORAGE AND STABILITY
The sealed reagents are stable upto the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear upto 600 U/L.
If the concentration is greater than linearity (600 U/L), dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
NORMAL VALUES
It is recommended that each laboratory should establish its own reference values.
The following value may be used as guide line.
Serum up to : 24 U/L
% CK- MB : 6 - 25 %
PREPARATION AND STABILITY OF WORKING REAGENT
Mix 4 volume of Reagent 1 (R1) with 1 volume of Reagent 2 (R2).
The working reagent is stable for 14 days at 2-80C.
NOTE: Discard the working reagent if the blank absorbance exceeds 1.0 at 340 nm.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of working reagent to light.
SAMPLE
Serum / plasma (Free of haemolysis)

ADL/V.02/February 2013

18
 2 x 10 mL, 2 x 30 mL
CK-NAC (S.L) 11404001,11404005
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of Creatine Kinase in Mode of Reaction Kinetic
human serum or plasma.
Slope of reaction Increasing
- Optimized IFCC Method
- Linear up to 1700 U/L Wavelength 340 nm
- Working Reagent can be prepared as per requirements Temperature 370C
CLINICAL SIGNIFICANCE Factor 4127
It is mainly found in all muscle (Cardiac & Skeletal) & brain tissues. It plays an important Linearity 1700 U/L
role in energy storing mechanism of the tissues. It’s iso-enzymes: CK-MB mainly exists Blank Distilled Water
in cardic muscle tissues, CK-MM in skeletal muscle tissues & CK-BB in brain.
Delay time 100 sec.
Increased levels are found in myocardical infarction, muscular dystrophy,
cerebrovascular-disease, pulmonary infarction, electrical shocks & hypothyroidisim. No of reading 3
Decreased levels are, some times seen in early pregnancy, alcoholic liver diseases and Interval 60 sec
RA. Reagent volume 1000 µL
PRINCIPLE Sample volume 40 µL
Kinetic determination of Creatine Kianse is based on following reactions:- Cuvette 1 cm light path
CK
Creatine Phosphate + ADP ---- > Creatine +ATP
LABORATORY PROCEDURE
HK
ATP + Glucose ---- > ADP + Glucose – 6- phosphate
Working reagent 1000 µL
G6P – DH
Sample 40 µL
G-6-P + NADP+ ----------- > D-Gluconate -6-phosphate + NADPH + H+
Mix and incubate at 370C for 100 seconds. Read the change in absorbance per minute
CK – Creatine Kinase ( OD/min) during 3 minutes.
HK – Hexokinase
G-6-P-Glucose-6-phosphate
G-6-PDH-Glucose-6-Phosphate dehydrogenase. TWO REAGENT PROCEDURE
REAGENT COMPOSITION
CK-NAC (S.L) R1 2 x 8 mL / 2 x24 mL Reagent 1 R1 – 200 µL
Immidazole buffer 125 mmol/L Reagent 2 R2 – 50 µL
D-Glucose 25 mmol/L Mix and wait for 25 seconds, add sample 10 µL, mix well and incubate for 2 minutes
0
N-Acetyl-L-cysteine 25 mmol/L at 37 C, measure the variation of absorbance per minute during 3 minutes.
Magnesium acetate 12.5 mmol/L CALCULATION
NADP 2.4 mmol/L Creatine Kinase Activity (U/L) = ( OD /min.) x 4127
EDTA 2.0 mmol/L
BIBLIOGRAPHY
Hexokinase >6800 U/L
1. DGKC, J.Clin. chem.Clin. Bioch.15, 255 (1977)
CK-NAC (S.L) R2 2 x 2 mL / 2 x 6 mL
2. Di. Witt, C. Tren delenburg, J. Clin chemie, Clin. Bioch. 20,235 (1982)
Creatine Phosphate 250 mmol/L
STORAGE AND STABILITY
The sealed reagents are stable upto the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 1700 U/L
If the concentration is greater than linearity (1700 U/L), dilute the sample with
normal saline and repeat the assay. Multiply the final result with dilution factor.
NORMAL VALUES
It is recommended that each laboratory establish its own reference value.
The following value may be used as guide line.
Men upto : < 171 U/L
Women upto : < 145 U/L
PREPARATION AND STABILITY OF WORKING REAGENT
Mix 4 volume of Reagent 1 (R1) with 1 volume of Reagent 2 (R2)
The working reagent is stable for 14 days at 2-80C.
NOTE: Discard the working reagent if the blank absorbance exceeds 1.0 at 340 nm.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of working reagent to light.
SAMPLE
Serum / Plasma (Free of haemolysis)

ADL/V.02/February 2013

19
 2 x 40 mL, 2 x60 mL, 4 x 60 mL
ENZYMATIC CREATININE 11420002, 11420003, 11420004
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination creatinine in serum or Mode of Reaction End point
urine.
Slope of reaction Increasing
- High Linearity of 200 mg/dL
- No sample dilution Wavelength I 546 nm
- Ready to use reagents Wavelength II 630
CLINICAL SIGNIFICANCE Temperature 370C
Creatinine is formed in muscles from phosphocreatinine. It is an important form of Standard Conc. 2 mg/dL
energy by being a store of high energy phosphate. Creatinine determinations have one Linearity 200 mg/dL
advantage over urea determination that it is not affected by a high protein diet.
Blank Reagent
Serum creatinine is more specific & sensitive indicator of renal function. Simultaneous
estimations of serum urea & creatinine provides better information. Serum urea Incubation time 10 min.
nitrogen & creatinine ratio is > 15 in prerenal failure & < 10 in renal failure. Decreased Sample volume 10 µL
levels are found in muscle dystrophy.
Reagent 1 volume 450 µL
PRINCIPLE Reagent 2 volume 150 µL
Creatininase
Cuvette 1 cm light path
Creatinine +H2O ------------------> Creatine
Creatinase
LABORATORY PROCEDURE
Creatine + H2O ------------------> Sarcosine +Urea
Blank Calibrator Sample
Sarcosine Oxidase
Reagent 1 450 µL 450 µL 450 µL
Sarcosine + O2+H2O ------------------------> Glycine + HCHO + H2O2
Calib./Std - 10 µL -
Peroxidase
Sample - - 10 µL
2 H2O2+ 4-AA *1+ TOOS *2 ---------------> Quinone pigment +4 H2O
Mix and incubate for 5 minutes at 370C then add,
* 1 : 4- Aminoantipyrine,
Reagent 2 150 µL 150 µL 150 µL
* 2 : N-ethyl-N-(2-hydroxy -3-sulfopropyl)-m-toluidine
Mix and incubate for 5 minutes at 370C. Measure the absorbance of sample and the
Creatinine concentration can be obtained by measuring quinone pigment standard against the reagent blank.
photometrically.
CALCULATION
REAGENT COMPOSITION
Absorbance of sample
CREATININE (S.L) R1 2 x 30 mL / 2 x 45 mL / 4x 45 mL
Creatinine Conc (mg/dL) = -------------------------------- x standard conc.
Creatinase 175000 IU/L
Absorbance of Standard
Sarcosine Oxidase 1500 IU/L
TOOS 1.13 mmol BIBLIOGRAPHY
CREATININE (S.L) R2 2 x 10 mL / 1 x 30 mL / 2 x 30 mL Artiss, J.D., Mc Enroe, R.J., Zak, B.; Clin.Chem, 30 (1984)1389.
Creatininase 75000 IU/L
Peroxidase 4500 units/L
4-AA 0.75 mmol
CREATININE STANDARD 1 x 4 mL
Creatinine Std. Conc. 2 mg/dL
STORAGE & STABILITY
The sealed reagents are stable upto the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear upto 200 mg/dL.
If the concentration is greater than linearity dilute the sample with normal saline and
repeat the assay. Multiply the result with dilution factor.
REFERENCE VALUES
It is recommended that each laboratory establish its own reference value.
The following value may be used as guide line.
Serum : male : 0.6 – 1.1 mg/dL
: Female : 0.5- 0.8 mg/dL
Urine : Male : 1070-2150 mg/dL (24 hrs accumulated urine)
: Female : 769 – 1200 mg/dL (24 hrs accumulated urine)
PREPARATION AND STABILITY OF WORKING REAGENT
Reagent 1 & Reagent 2 are ready to use.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
SAMPLE
Fresh Serum/urine(24 hour)

ADL/V.02/February 2013

20
 2 x 10 mL, 2 x 30 mL
GAMMA GT(S.L) 11416001, 11416005
INTENDED USE Blank DI Water
This reagent is intended for in vitro Quantitative determination of gamma GT in serum. Delay 60 sec
- Szasz methodology No of readings 3
- Linear upto 232 U/L
Interval 60 sec
- Working reagent can be prepared as per requirements
Sample volume 100 µL
CLINICAL SIGNIFICANCE
Reagent volume 1000 µL
GGT activity is elevated in all forms of liver diseases. It is highest in cases of intrahepatic
or post hepatic biliary obstruction. (It may be 5 to 30 times higher than normal). It is Cuvette 1 cm light path
more sensitive than alkaline phosphatase NTP leucine amino peptidase and LABORATORY PROCEDURE
transaminases in detection of obstructive jaundice, cholangitis, cholecystis neoplasm, Working reagent 1000 µL
it rises earlier than other enzyme and persists longer. Sample 100 µL
Moderate increase is observed in infectious hepatitis (2 to 5 times). Increases may 0
Mix and incubate for 1 minute at 37 C. Read the change in absorbance per minute
also be observed in cases of drug intoxication, acute and chronic pancreatitis. ( OD/min) during 3 minutes.
PRINCIPLE CALCULATION
Kinetic determination of Gamma GT according to the following reaction. Gamma GT activity (U/L) = ( OD/min) x 1158
Gamma GT
GLUPA-C+Glycylglycine ---------------> L-Gamma-Glutamyl-GlycyLglycine + BIBLIOGRAPHY
5-Amino-2-nitrobenzoic acid. 1. Szasz, G.; Clin.Chem., 22, (1976),2051.
2. Scand. J.Clin. Lab.Invest 36:711 (1976)
GLUPA-C: L-Gamma -Glutamyl-3 Carboxy-p-nitroanilide 3. Tietz, N.W.; Text book of Clin.Chem. 678-686 : (1986)
REAGENT COMPOSITION
Gamma GT R1 2 x 8 mL / 2 x 24 mL
Tris buffer pH (8.25) 133 mmol/L
Glycylglycine 138 mmol/L
Gamma GT R2 2 x 2 mL / 2 x 6 mL
GLUPA-C 23 mmol/L
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 232 U/L.
If the concentration is greater than linearity (232 U/L) dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
NORMAL VALUES
It is recommended that each laboratory establish its own reference value.
The following values may be used as guide line.
Female : 5 - 32 U/L
Male : 10 - 45 U/L
PREPARATION AND STABILITY OF WORKING REAGENT
Mix 4 volume of Reagent 1 (R1) with 1 volume of reagent 2 (R2). This working reagent
is stable for 21 days at 2-80C.
Note: Discard the working reagent if the blank absorbance exceeds 1.0 at 405 nm.
PRECAU TION:To avoid contamination, use clean laboratory wares.
Avoid direct exposure of working reagent to light.
SAMPLE
Fresh Serum (free of haemolysis).
GENERAL SYSTEM PARAMETER
Mode of Reaction Kinetic
Slope of reaction Increasing
Wavelength 405 nm
Temperature 37 0C
Factor 1158
Linearity 232 U/L

21
 5 x 100 mL, 1 x 1000 mL
GLUCOSE (S.L) 11406001, 11406002
INTENDED USE Blank Reagent
This reagent is intended for in vitro quantitative determination of Glucose in serum, Sample volume 10 µL
plasma & CSF.
Reagent volume 1000 µL
- GOD-PAP methodology
- Linear upto 600 mg/dL Cuvette 1 cm light path

CLINICAL SIGNIFICANCE LABORATORY PROCEDURE

Glucose is a major carbohydrate present in the blood & serves as a primary source of Blank Standard Sample
energy. It is usually obtained from ingested starch & sugar. The glucose concentration Working Reagent 1000 µL 1000 µL 1000 µL
is normally maintained at a constant level. Excessive glucose is stored as inactive Standard - 10 µL -
glycogen mainly in the liver & little in the muscles.
Elevated blood glucose levels are found in diabetes mellitus, hyperthyroidism, Sample - - 10 µL
hyperadrenalism & certain liver diseases. Mix and incubate for 10 minutes at 370C. Read the absorbance of standard and sample
Decreased levels are found in Insulinoma, hypothyroidism, hypopituitarism. against reagent blank.
PRINCIPLE CALCULATION
Enzymatic colorimetric determination of glucose according to the following reaction. Absorbance of Sample
Glucose Oxidase Glucose Conc. (mg/dL) = -------------------------- x 100
Glucose+ O2 + H2O -----------------------> Gluconic acid + H2O2 Absorbance of standard
Peroxidase BIBLIOGRAPHY
2H2O2+phenol + 4-Aminoantipyrine -------------------> Quinonimine + 4H2O 1. Trinder, P.; Ann Clin Biochem. 6,24 (1969)
REAGENT COMPOSITION 2. Dingeon, B.; Ann.Bio.Clin 33,3 (1975)
3. Lott, J. ; Clin.Chem. 21, 1754 (1975)
GLUCOSE (S.L) R1 5 x 100 mL / 1 x 1000 mL
Tris Buffer, (pH 7.40) 92 mmol/L
Phenol 0.3 mmol/L
Glucose Oxidase 15000 U/L
4- Aminophenazone 2.6 mmol/L
GLUCOSE STANDARD 1 x 4 mL
Glucose standard concentration 100 mg/dL
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 600 mg/dL
If the concentration is greater than linearity (600 mg/dL), dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum / Plasma : 70-105 mg/dL
CSF : 50 -70 mg/dL
PREPARATION AND STABILITY OF WORKING REAGENT
The Reagent is ready to use.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
SAMPLE
Serum / plasma (free of haemolysis) / CSF
GENERAL SYSTEM PARAMETER
Mode of Reaction End Point
Slope of reaction Increasing
Wavelength 505 (490-550 nm)
Temperature 37 0C
Standard Concentration 100 mg/dL
Linearity 600 mg/dL
Incubation Time 10 Minutes

22
 2 x 40 mL / 2 x 60 mL / 4 x 60 mL
HDL CHOLESTEROL (D) WITH CALIBRATOR 11414003, 11414005, 11414004

INTENDED USE Wavelength II 630 nm (630-700)

This reagent is intended for in vitro quantitative determination of HDL Cholesterol in Temperature 370C
serum Calibrator Con As on the vial
- Direct determination of HDL Cholesterol Linearity 150 mg/dL
- Enzyme Selective Protection Method Incubation time 5 min+5 min
- Linear up to 150 mg/dL Blank Reagent
- Ready to use liquid stable reagents Sample volume 5 µL
CLINICAL SIGNIFICANCE Reagent volume 450 µL+150 µL
Blood total cholesterol levels have long been known to be related to coronary heart Cuvette 1 cm light path
disease (CHD). In recent years, in addition to total cholesterol, high density LABORATORY PROCEDURE
lipoprotein cholesterol (HDL-C) has become an important tool used to assess an
individual risk of developing CHD since a strong negative relationship between Blank Calibrator Sample
HDL - C concentration and the incidence of CHD was reported. Reagent1 450 µL 450 µL 450 µL
Calibrator - 5 µL -
PRINCIPLE
Sample - - 5 µL
The reaction between cholesterol other than HDL and the enzyme for cholesterol
assay is suppressed by the electrostatic interaction between polyanions & cationic Mix and incubate for 5 minutes at 370C.
substances. Hydrogen peroxide is formed by the free cholesterol in HDL by cholesterol Reagent 2 150 µL 150 µL 150 µL
oxidase. Oxidative condensation of EMSE and 4-AA is caused by hydrogen peroxide Mix and incubate for 5 minutes at 370C. Measure the absorbance of calibrator &
in the presence of peroxidase, and the absorbance of the resulting red-purple quinone sample against reagent blank at 578nm/ 630 nm.
is measured to obtain the cholesterol value in HDL
CALCULATION
Polyanions
Absorbance of Sample
Other lipoproteins than HDL --------------> Suppress reaction with enzyme
HDL-C Concentration (mg/dL) = ------------------------------ x Calibrator Concentration
Cationic substances
Absorbance of Calibrator
cholesterol esterase
HDL (cholesterol esters) + H2O --------------------------> HDL (free cholesterol) + ALTERNATIVE PROCEDURE
Free fatty acids Mode of Reaction Differential
cholesterol oxidase Slope of reaction Increasing
HDL (free cholesterol) + O2 + H+ -------------------------> Cholestenone + H2O2
Wavelength I 600 nm
Peroxidase
2H2O2 + 4-AA + EMSE + H3 + O ---------------> Red-purple quinone + 5H2O Wavelength II 700 nm
Temperature 370C
REAGENT COMPOSITION
HDL –C DIRECT R1 2 x 30 mL / 2 x 45 / 4 x 45 mL Calibrator Concentration As on the vial label
N—ethyl-N-(3-methylphenyl)-N’succinylethyenediame(EMSE) Linearity 150 mg/dL
HDL –C DIRECT R2 2 x 10 / 1 x 30 / 2 x 30 mL Blank Reagent
Cholesterol Oxidase Incubation time 5 minutes+5 minutes
4-Aminoantipyrin(4-AA) Sample volume 3 µL
HDL –C DIRECT CALIBRATOR 1 x 3 mL
Reagent volume 270 µL + 90 µL
STORAGE AND STABILITY Cuvette 1 cm light path
The sealed reagents are stable upto the expiry date stated on the label, when stored LABORATORY PROCEDURE
at 2 - 80C, protected from light. Do not freeze.
Blank Calibrator Sample
LINEARITY Reagent1 270 µL 270 µL 270 µL
This reagent is linear upto 150 mg/dL Calibrator - 3 µL -
If the concentration is greater than linearity (150 mg/dL), dilute the sample with normal Sample - - 3 µL
saline and repeat the assay. Multiply the result with dilution factor 0
Mix and incubate for 5 minutes at 37 C. Measure the absorbance (OD1) at 600 nm/
NORMAL RANGE 700 nm.
It is recommended that each laboratory establish its own reference values. Reagent 2 90 µL 90 µL 90 µL
The following value may be used as guide line. Mix and incubate for 5 minutes at 370C. Measure the absorbance (OD2) at 600 nm/
Male : 35 - 80 mg/dL 700 nm.
Female : 42 - 88 mg/dL CALCULATION
PREPARATION AND STABILITY OF WORKING REAGENT (OD2-OD1) Sample
The Reagent1 & Reagent 2 are ready to use. HDL-C Concentration (mg/dL) = ---------------------------- x Calibrator Conc.
Calibrator : Reconstitute with 3 mL of distilled water. Let it stand for 30 minutes at (OD2-OD1) Calibrator
room temperature. Dissolve the content of the vial by swirling gently to avoid the INTERFERING SUBSTANCES
formation of foam. Test will not be affected by:
Stability : Reconstituted calibrator is stable only for 7 days at 2- 80C. Bilirubin up to 40 mg/dL
PRECAUTION Ascorbic acid up to 50 mg/dL
To avoid contamination, use clean laboratory wares. Use clean, dry disposable Hemoglobin up to 500 mg/dL
pipette tips for dispensing. Close reagent bottles immediately after use. Avoid direct Triglyceride up to 1000 mg/dL
exposure of reagent to light. Do not blow into the reagent bottles. *(when triglyceride in a sample exceeds 1000 mg/dL, dilute the sample 1+9 with
SAMPLE saline, repeat the assay and multiply result by 10)
Fresh serum (free of haemolysis) BIBLIOGRAPHY
GENERAL SYSTEM PARAMETER 1. Williams, P., et al.; High density lipoprotein and coronary risk factor, Lancet. 1:72
(1979)
Mode of Reaction End Point 2. Gordon,T., Castelli, W.P., Hjortland, M.C. et al. Am. J.Med. 62, 707-714 (1977)
Slope of reaction Increasing 3. Rifai,N.and Warnick, G.R.,Ed. Laboratory Measurement of Lipids, Lipoproteins
Wavelength I 578 nm(578-610) and Apolipoproteins AACC Press. Washington, DC,USA,1994

ADL/V.02/February 2013

23
 2 x 10 mL, 2 x 30 mL
LDH-P (S.L) 11407001, 11407004
INTENDED USE Linearity 2400 U/L
This reagent is intended for in vitro quantitative determination of Lactate Delay 60 sec.
dehydrogenase in serum or plasma. No of reading 3
- Based on SCE recommended method
Interval 60 sec
- Linear up to 2400 U/L
Sample volume 10 µL
CLINICAL SIGNIFICANCE
Reagent volume 1000 µL
This enzyme is found in all organ cells, but especially plentiful in cardiac & skeletal
muscle, liver, kidney & RBC. LDH is found in the form of iso-enzymes based on their Cuvette 1 cm light path
electrophoretic mobility with each iso-enzymes being primarily from different organs. LABORATORY PROCEDURE
Elevated levels are found in myocardial infarction, liver diseases, hemolytic anaemias, Working reagent 1000 µL
pernicious anaemia, Leukemia & Pulmonary diseases. Elevations in acute MI reaches
a peak in 48-72 hrs. belonged elevations, (10-14 days) are useful in the late diagnosis Sample 10 µL
of the condition. Mix and incubate at 370C for 1 minute. Measure the change in absorbance per minute
( OD/min) during 3 minutes.
PRINCIPLE
Kinetic determination of lactate dehydrogenase according to the following reaction. CALCULATION
LDH LDH-P activity (U/L) = ( OD/min) x 16030
Pyruvate + NADH + H+ --------------> L-Lactate +NAD+ BIBLIOGRAPHY
REAGENT COMPOSITION 1. Z.Klin. chem. Klin Biochem.8,658 (1970), 1, 1820(1972)
2. Wei Bhaar, D., et al.; Med.Welt 26,387 (1975)
LDH-P (S.L) R1 2 x 8mL / 2 x 24mL
Tris buffer (pH 7.4) 80 mmol/L
Pyruvate 1.6 mmol/L
Sodium chloride 200 mmol/L
LDH-P (S.L) R2 2 x 2 mL / 2 x 6 mL
NADH 240 mmol/L
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 2400 U/L.
If the concentration is greater than linearity (2400 U/L), dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum /Plasma : 225-450 U/L
PREPARATION AND STABILITY OF WORKING REAGENT
Mix 4 volumes of Reagent 1 (R1) with 1 volume of Reagent 2 (R2)
The working reagent is stable for 21 days at 2-80C.
NOTE: Discard the working reagent if the blank absorbance is less than 1.0 at 340
nm.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
SAMPLE
Serum / plasma (free of haemolysis)
GENERAL SYSTEM PARAMETER
Mode of Reaction Kinetic
Slope of reaction Decreasing
Wavelength 340 nm
Temperature 37 0C
Factor 16030

24
 2 x 40 mL, 2 x 60 mL
LDL CHOLESTEROL (D) WITH CALIBRATOR 11415003, 11415004
INTENDED USE Temperature 370C
This reagent is intended for in vitro quantitative determination of LDL Cholesterol in
serum or plasma Calibrator Concentration As on the vial label
- Direct determination of LDL Cholesterol Linearity 450 mg/dL
- Enzyme selective protection method Blank Reagent
- Linear up to 450 mg/dL Incubation time 5 min + 5 min
- Ready to use liquid stable reagents Sample volume 3 µL
CLINICAL SIGNIFICANCE Reagent volume 270 µL + 90 µL
Blood total cholesterol levels have long been known to be related to coronary heart Cuvette 1 cm light path
disease (CHD). In recent years, in addition to total cholesterol, low density
lipoprotein cholesterol (LDL-C) has become an important tool used to assess an LABORATORY PROCEDURE
individual risk of developing CHD since a strong positive relationship between LDL- DIFFERENTIAL MEASUREMENT
C concentration and the incidence of CHD was reported. LDL Cholestrol acts as a Blank Calibrator Sample
key factor in the pathogenesis of atherosclerosis and coronary artery disease. Reagent 1 270 µL 270 µL 270 µL
PRINCIPLE Calibrator - 3 µL -
The LDL-C Direct is a homogeneous assay for directly measuring LDL-C levels in Sample - - 3 µL
serum or plasma without the need for any off-line pretreatment or centrifugation Mix and incubate for 5 minutes at 370C. Measure the absorbance (OD1) at 546 nm/
In the first reaction, non LDL unesterified cholesterol is subject to an enzyme 660 nm.
reaction and the peroxide generated is consumed by peroxidase in the presence of
4-AAP to yield a colorless product. The second reagent consists of a detergent Reagent 2 90 µL 90 µL 90 µL
capable of solubilizing LDL specifically. Cholesterol esterase and chromogenic Mix and incubate for 5 minutes at 370C. Measure the absorbance (OD2) at 546 nm/
coupler react with this solubilize LDL-C to develop color. The intensity of color 660 nm.
formed is directly proportional to the concentration of LDL-C.
CALCULATION
REAGENT COMPOSITION LDL - C Concentration (mg/dL) =
LDL –C DIRECT R1 2 x 30 mL / 2 x 45 mL (OD2-OD1) Sample
4-Aminoantipyrin 0.5 mmol/L --------------------------- x Calibrator Concentration
CHE (OD2-OD1) Calibrator
CO 1.2 U/mL ALTERNATIVE MEASUREMENT
Peroxidase Mode of Reaction End Point
Good’s buffer pH 6.3
Slope of reaction Increasing
LDL –C DIRECT R2 2 x 10 / 1 x 30 mL
N,N-bis(4-sulfobutyl)-m-toluidine Wavelength I 546 nm
disodium salt (DSBmT) 1.0 mmol/L Wavelength II 630 nm
Good’s buffer pH 6.3 Temperature 370C
LDL –C DIRECT CALIBRATOR 1 x 3 mL Calibrator Concentration As on the vial label
Linearity 450 mg/dL
STORAGE AND STABILITY
Blank Reagent
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C, protected from light. Do not freeze. Incubation time 5 min +5 min
LINEARITY Sample volume 5 µL
This reagent is linear up to 450 mg/dL Reagent volume 450 µL + 150 µL
If the concentration is greater than linearity (450 mg/dL), dilute the sample with Cuvette 1 cm light path
normal saline and repeat the assay. Multiply the result with dilution factor LABORATORY PROCEDURE
NORMAL RANGE Blank Calibrator Sample
It is recommended that each laboratory establish its own reference values. Reagent 1 450 µL 450 µL 450 µL
The following value may be used as guide line. Calibrator - 5 µL -
Desirable < 130 mg/dL Sample - - 5 µL
Borderline High Risk for CHD 130-159 mg/dL
Mix and incubate for 5 minutes at 370C.
High Risk for CHD >160 mg/dL.
Reagent 2 150 µL 150 µL 150 µL
PREPARATION AND STABILITY OF REAGENT
The Reagent 1 & Reagent 2 are ready to use. Mix and incubate for 5 minutes at 370C. Measure the absorbance of calibrator &
sample against reagent blank at 546 nm/630 nm.
Calibrator : Reconstitute with 3 mL of distilled water. Let it stand for 2 hours at room
temperature. Dissolve the content of the vial by swirling gently to avoid the CALCULATION
formation of foam. Absorbance of Sample
Stability : Reconstituted calibrator is stable only for 7 days at 2- 80C. LDL - C Concentration (mg/dL) = ------------------------------- x Calibrator Concentration
PRECAUTION Absorbance of Calibrator
To avoid contamination, use clean laboratory wares. Use clean, dry disposable INTERFERING SUBSTANCES
pipette tips for dispensing. Close reagent bottles immediately after use. Avoid direct Test will not be affected by:
exposure of reagent to light. Do not blow into the reagent bottles. Bilirubin up to 40 mg/dL
SAMPLE Ascorbic acid up to 50 mg/dL
Fresh serum (free of haemolysis) / EDTA Plasma Haemoglobin up to 500 mg/dL
Triglyceride up to 1000 mg/dL
GENERAL SYSTEM PARAMETER
*(when triglyceride in a sample exceeds 1000 mg/dL, dilute the sample 1+9 with saline,
Mode of Reaction Differential repeat the assay and multiply result by 10)
Slope of reaction Increasing BIBLIOGRAPHY
Wavelength I 546 nm 1. Crouse, J.R., et al.; Studies of Low Density Lipoprotein molecular weight in human
Wavelength II 660 nm being with coronary artery disease. J.Lipid Res 26:5666 (1985)

ADL/V.02/February 2013

25
 1 x 25 mL
LIPASE(S.L) 11417001
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of lipase in human Mode of Reaction Kinetic Fixed Time
serum or plasma. Slope of reaction Increasing Increasing
- Methyl resorufin method Wavelength 580 nm 580 nm
- Linear up to 300 U/L Temperature 37 0C 37 0C
- Reagent is ready for use Calibrator concentration As on the vial As on the vial
CLINICAL SIGNIFICANCE Linearity 300 U/L 300 U/L
Lipase is a pancreatic enzyme necessary for the absorption and digestion of Blank Reagent Reagent
nutrients that catalyses the hydrolysis of glycerol esters of fatty acids. Determination Delay time 120 sec. 120 sec
of lipase is used for diagnosis of diseases such as acute and chronic pancreatitis No of reading 2 -
and obstruction of the pancreatic duct. Clinical diagnosis should not be made on a Interval 60 sec 120 sec
single test result; it should integrate clinical and other laboratory data.
Sample volume 20 µL 20 µL
PRINCIPLE Reagent volume 1250 µL (1000+250) 1250 µL (1000 + 250)
In the presence of colipase and bile acids lipase splits the synthetic substrate (1,2- Cuvette 1cm light path 1 cm light path
O-Dilauryl-rac-glycero-3-glutaricacid (6-methyl-resorufin-ester) to glycerol and LABORATORY PROCEDURE
methylresorufin-ester, which is spontaneously degraded to glutaric acid and
methylresorufin. The rate of methylresorufin formation, measured photometrically Blank Calibrator Sample
is proportional to the catalytic concentration of lipase present in the sample. Reagent 1 1000 µL 1000 µL 1000 µL
Calibrator - 20 µL -
REAGENT COMPOSITION
Sample - - 20 µL
LIPASE (S.L) R1 2 x 10 mL Dist. water 20 µL - -
Goods Buffer (pH 8.0) 40 mmol/L 0
Mix carefully (do not vortex); incubate for 1-5 minutes at 37 C. Then add
Taurodeoxycholate 3.4 mmol/L Reagent 2 250 µL 250 µL 250 µL
Deoxycholate 6.4 mmol/L Mix and incubate for 2 min at 37oC, read absorbance against reagent blank. Measure
Calcium chloride 12 mmol/L the change in absorbance per minute ( OD/min) during 2 min.
Colipase 1.7 mg/dL or
Mix and read the optical density (T1) 120 seconds after the Reagent 2 addition. Take
LIPASE(S.L) R2 1 x 5 mL second reading (T 2) exactly after 120 seconds.
Tartrate Buffer (pH 4.0) 1.5 mmol/L
Taurodeoxycholate 3.4 mmol/L CALCULATION
Color substrate 0.13 mmol/L Lipase U/L =
LIPASE CALIBRATOR 1 x 3 mL ( OD/min) Sample - ( OD/min) Blank
Lipase calibrator concentration is stated on the vial label. ---------------------------------------------------- x Calibrator concentration
( OD/min) calibrator - ( OD/min) Blank
STORAGE & STABILITY or
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C, protected from light.
(T2-T1 ) of sample
LINEARITY ------------------------- x Calibrator concentration
This reagent is linear up to 300 U/L. (T2-T1 ) of standard
If the concentration is greater than linearity (300 U/L), dilute the sample with
normal saline and repeat the assay. Multiply the result with dilution factor. BIBLIOGRAPHY
1. Mc Neely , M. ; Lipase. Kaplan, A. et al.; Clin. Chem. The C.V.Mosby Co. St Louis,
NORMAL RANGE Toronto. Princeton 1984, 1130-1135
It is recommended that each laboratory establish its own reference values. 2. Burtis, A., et al. ; Tietz Textbook of Clinical chemistry, 3rd ed AACC
The following value may be used as guide line. 3. Neumann, U., et al.; Methods of Enzymatic Analysis, Vol 4, 3rd Ed.
Serum / Plasma : Up to 60 U/L
PREPARATION AND STABILITY OF REAGENT
Lipase R1 and Lipase R2 are ready to use.
Calibrator : Reconstitute with 3 mL of distilled water. Dissolve the content of the
vial by swirling gently to avoid the formation of foam.
Stability : Reconstituted calibrator is stable only for 7 days at 2-80C and 3 months
at -200C.
PRECAUTION
To avoid contamination, use clean laboratory wares. Use clean dry disposable
pipette tips for dispensing. Close reagent and calibrator bottles immediately after
Use. Avoid direct exposure of reagent to light.
SAMPLE
Serum or plasma with sodium citrate, EDTA or heparin.

ADL/V.02/February 2013

26
 2 x 30 mL, 3 x 50 mL, 4 x 125 mL
SGOT (S.L) 11408005, 11408003, 11408007
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of SGOT in serum or Normal procedure High Linearity procedure
plasma. Mode of Reaction Kinetic Kinetic
- IFCC recommended procedure Slope of reaction Decreasing Decreasing
- Linear up to 1000 U/L Wavelength 340 nm 340 nm
- Working reagent can be prepared as per requirements Temperature 37 0C 37 0C
CLINICAL SIGNIFICANCE Factor 1745 1745
It is present in most of the tissues. Especially in cardiac muscle, liver cells, skeletal Linearity 350 U/L 1000 U/L
muscle & kidneys. Injury to these tissues results in the release of the enzyme in blood Blank DI Water DI Water
stream. Delay 60 sec 60 sec
Increased levels are found in myocardial infarction. The duration & extent of increase No of reading 3 3
is related to the infract. GOT determination is of considerable value to differentiate Interval 60 sec 20 sec
myocardial infarction from other cardiac disorders.
Sample volume 100 µL 100 µL
Increased levels are also found in various types of liver disease, skeletal muscle trauma
& in renal diseases. Reagent volume 1000 µL 1000 µL
Decreased levels may be found in pregnancy, Beri-Beri & Diabetic ketoacidosis. Cuvette 1 cm light path 1 cm light path
LABORATORY PROCEDURE
PRINCIPLE Working reagent 1000 µL
Kinetic determination of Aspartate Aminotrasferase (AST) based upon the following Sample 100 µL
reaction. 0
Mix and incubate at 37 C for 1 minute. Measure the change in absorbance per minute
AST ( OD/min) during 3 minutes.
L- Asparate + alpha - ketoglutarate ----- > Oxaloacetate + L-Glutamate.
MDH High Linearity Procedure
Oxaloacetate + NADH + H+ -------- > L- Malate + NAD+ Mix and incubate at for 1 minutes 370C. Read the change in absorbance per 20 sec,
during 1 minute.
AST: Aspartate aminotransferase.
MDH : Malate dehydrogenase. CALCULATION
SGOT activity (U/L) = ( OD/min) x 1745
REAGENT COMPOSITION
SGOT (S.L) R1 2 x 24 mL / 3 x 40 mL / 4 x 100 mL BIBLIOGRAPHY
Tris Buffer (pH 7.8) 88 mmol/L 1. Clin. Chem, Acta. 70, 19-42 (1976)
L-Aspartate 260 mmol/L 2. Thefeld, W., et al.; Dtsch. Med Wschr.99, 343 (1974)
LDH > 1500 U/L
MDH > 900 U/L
SGOT (S.L)R2 2 x 6 mL / 3 x 10 mL / 4 x 25 mL
alpha -ketoglutarate 12 mmol/L
NADH 0.24 mmol/L
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 1000 U/L.
If the concentration is greater than 350 U/L, follow the high linearity procedure to
get higher linearity of 1000 U/L.
If the concentration is greater than linearity, dilute the sample with normal saline and
repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum up to : 46 U/L
PREPARATION AND STABILITY OF WORKING REAGENT
Mix 4 volumes of Reagent 1 (R1 ) with 1 volume of Reagent 2 (R2)
The working reagent is stable for 30 days at 2-80C.
NOTE: Discard the working reagent if the blank absorbance is less than 1.0 at 340 nm.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
SAMPLE
Serum / plasma (free of haemolysis)

27
 2 x 30 mL, 3 x 50 mL, 4 x 125 mL
SGPT (S.L) 11409005, 11409003, 11409006
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of SGPT in serum or Normal procedure High Linearity procedure
plasma. Mode of Reaction Kinetic Kinetic
- IFCC recommended methodology Slope of reaction Decreasing Decreasing
- Linear up to 1000 U/L Wavelength 340 nm 340 nm
- Working reagent can be prepared as per requirements Temperature 37 0C 37 0C
CLINICAL SIGNIFICANCE Factor 1745 1745
It is present in most of the tissues, but mainly found in the liver. Increased levels are Linearity 350 U/L 1000 U/L
found in hepatitis, cirrhosis, obstructive jaundice & other hepatic disease. SGPT activity Blank DI Water DI Water
is markedly elevated even before clinical signs of jaundice become apparent in disease Delay 60 sec 60 sec
associated with hepatic necrosis. Slight elevations are also found in myocardial No of reading 3 3
infarction. Interval 60 sec 20 sec
PRINCIPLE Sample volume 100 µL 100 µL
Kinetic determination of Alanine Aminotransferase (ALT) according to the following Reagent volume 1000 µL 1000 µL
reaction. Cuvette 1 cm light path 1 cm light path
ALT
L-Alanine + alpha-ketogutarate ----- >Pyruvate +L-Glutamate LABORATORY PROCEDURE
LDH Working reagent 1000 µL
Pyruvate +NADH+ H+ ----- > L-Lactate +NAD+ Sample 100 µL
ALT – Alanine aminotranferase 0
Mix and incubate at 37 C for 1 minute. Measure the change in absorbance per minute
LDH - Lactate dehydrogenase ( OD/min) during 3 minutes.
REAGENT COMPOSITION High Linearity Procedure
SGPT (S.L) R1 2 x 24 mL / 3 x 40 mL / 4 x 100 mL Mix and incubate for 1 minute at 370C. Read the change in absorbance per 20 sec
during 1 minutes.
Tris buffer (pH 7.5) 110 mmol/L
L-Alanine 600 mmol/L CALCULATION
LDH > 1500U/L SGPT activity (U/L) = ( OD/min) x 1745
SGPT (S.L)R2 2 x 6 ml / 3 x 10 mL / 4 x 25 mL BIBLIOGRAPHY
alpha-ketoglutarate 16 mmol/L 1. Clin. Chem, Acta. 105, 147-172 (1780)
NADH 0.24 mmol/L 2. Thefeld, W., et al.; Dtsch. Med Wschr.99, 343 (1994)
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 1000 U/L.
If the concentration is greater than 350 U/L, follow the high linearity procedure to
get higher linearity of 1000 U/L.
If the concentration is greater than linearity dilute the sample with normal saline and
repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum up to : 49 U/L
PREPARATION AND STABILITY OF WORKING REAGENT
Mix 4 volumes of Reagent 1 (R1) with 1 volume of Reagent 2 (R2)
The working reagent is stable for 30 days at 2-80C.
NOTE: Discard the working reagent if the blank absorbance is less than 1.00 at 340
nm.
PRECAUTION
To avoid contamination use clean laboratory wares.
Avoid direct exposure of working reagent to light.
SAMPLE
Serum / plasma (free of haemolysis)

28
 4x 10 mL, 5 x 25 mL, 6x 50 mL, 5 x 100 mL
TRIGLYCERIDES (S.L) 11410007, 11410002, 11410008, 11410004
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of triglycerides in serum Mode of Reaction End Point
or plasma.
Slope of reaction Increasing
- GPO-PAP methodology
- Linear up to 1000 mg/dL Wavelength I 505 nm (492-550 nm)
- Contains LCF (Lipaemic clearing factor) which minimizes rerun Wavelength II 630 nm
CLINICAL SIGNIFICANCE Temperature 370C
Triglycerides are simple lipids, formed in the liver by glycerol & fatty acids. They Standard Concentration 200 mg/dL
are transported by VLDL, LDL & constitute about 95% of fat, stored as source of Linearity 1000 mg/dL
energy in the tissue & plasma.
Blank Reagent
Increased levels are found in hyperlipidemias, diabetes, nephrotic syndrome &
hypothyroidism. Increased levels are risk factor for arteriosclerotic coronary disease, Incubation time 5 min
peripheral vascular disease, acute pancreatitis & hyperlipoproteinaemia. Decreased Sample volume 10 µL
levels are found in malnutrition & hyperthyroidism.
Reagent volume 1000 µL
PRINCIPLE Cuvette 1 cm light path
Enzymatic determination of triglyceride is based on following reactions: LABORATORY PROCEDURE
LPL Blank Standard Sample
TGL+H2O ------ > Glycerol + Fatty acid Working Reagent 1000 µL 1000 µL 1000 µL
GK Standard - 10 µL -
Glycerol + ATP ------ > Glycerol-3-phosphate + ADP Sample - - 10 µL
Mg++ Mix and incubate for 5 minutes at 370C. Measure the change in absorbance of
GPO standard and sample against reagent blank.
Glycerol-3-phospahte+O2 ------- > Dihydroxyacetone phosphate +H2O2
CALCULATION
POD
Absorbance of Sample
2H2O2+4-Aminoantipyrine+ p-chlorophenol ------- > Red Quinoneinimine
Triglycerides Con. (mg/dL) = ------------------------------ x 200
GPO = Glycereol-3-phosphate Oxidase
Absorbance of Standard
LPL = Lipoprotein Lipase
GK = Glycerol Kinase BIBLIOGRAPHY
1. Schettler, G., Nussel, E.; Arav. Med 10, 25 (1975)
REAGENT COMPOSITION 2. Jacobs, N.J. , VanDemark, P.J.; Arch, Biochem, Biophy. 88, 250 – 255 (1960)
TRIGLYCERIDES REAGENT 4x10mL / 5x25mL / 6x50mL / 5x100mL
Pipes –buffer (pH 7.00) 50 mmol/L
p-Chlorophenol 5.3 mmol/L
Potassium ferrocynate 10 mmol/L
Magnesium Salt 17 mmol/L
4-Aminoantipyrine 0.9 mmol/L
ATP 3.15mmol/L
Lipoprotein Lipase > 1800 U/L
Glycerol Kinase > 450 U/L
Glycerol – 3- phosphate oxidase > 3500 U/L
Peroxidase > 450 U/L
TRIGLYCERIDES STANDARD 1 x 4 mL
Triglycerides std.concentration 200 mg/dL
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 1000 mg/dL.
If the concentration is greater than linearity (1000 mg/dL), dilute the sample with
normal saline and repeat the assay. Multiply the result with dilution factor.
REFERENCE RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Male : 60-165 mg/dL
Female : 40-140 mg/dL
PREPARATION AND STABILITY OF REAGENT
The reagent ready to use.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
SAMPLE
Serum / plasma (free of haemolysis)

ADL/V.02/February 2013

29
 2 x 30 mL, 2 x 50mL, 2 x 125 mL
UREA U.V (S.L) 11412007, 11412002, 11412008
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of urea in serum, plasma Mode of Reaction Fixed Time
& urine.
Slope of reaction Decreasing
- Urease / GLDH methodology
- Linear up to 300 mg/dL Wavelength 340
- Working reagent can be prepared as per requirement Temperature 370C
CLINICAL SIGNIFICANCE Blank DI Water
Proteins cannot be stored in human body, so excess should be broken down. Amino Standard Concentration 50 mg/dL
acids which from the components of proteins, break down to give ammonia. This is Linearity 300 mg/dL
toxic & so through a series of chemical reactions (urea cycle) non toxic urea is
produced & this is released into the blood which is filtered in the kidney & excreted Delay time 30 sec
in the urine. Interval 60 sec
Elevated levels are seen during increased protein breakdown, dehydration, vomiting, Sample volume 10 µL
diarrhea. Also seen in any kind of renal disorder like Glomerular nephritis, Chronic
nephritis & Nephritic syndrome. Reagent volume 1000 µL
Decreased levels are found in liver failure & pregnancy. Cuvette 1 cm light path
LABORATORY PROCEDURE
PRINCIPLE
Standard Sample
Enzymatic determination of Urea according to the following reaction.
Working Reagent 1000 µL 1000 µL
Urease
Standard 10 µL -
Urea + H2O ------------> 2NH3 + CO2
Sample - 10 µL
GLDH
Mix and read the optical density (T 1) 30 seconds after the sample or standard
2 NH3 +2- ketoglutarate + 2NADH ----------> L-Glutamate+2NAD+ + 2H2O addition. Take second reading (T2) exactly 60 seconds after the first reading.
REAGENT COMPOSITION
UREA U.V (S.L) R1 2 x 24 mL/ 2 x 40 mL/ 2 x 100 mL CALCULATION
Tris Buffer (pH 7.60) 100 mmol/L ( T1 –T2)of Sample
ADP 0.7 mmol/L Urea Conc. (mg/dL) = ------------------------ x 50
a-ketoglutarate 9.0 mmol/L (T1-T2) of standard
Urease > 6500 U/L
GLDH > 1100 U/L (T1 –T2) of Sample
UREA U.V (S.L) R2 2 x 6 mL/ 2 x 10 mL / 2 x 25 mL Urea BUN Conc. (mg/dL) = ------------------------ x 23.4
NADH 0.25 mmol/L (T1-T2) of standard
2-Oxoglutarate 5 mmol/L BIBLIOGRAPHY
UREA U.V STANDARD 1 x 4 mL 1. Kassirer, J.P. New eng. J. Med.285, 385 (1971)
Standard concentration for Urea 50 mg/dL 2. Talke, H., Schubert, G.E. ; Klin. Wochenschr, 43, 174(1965)
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 300 mg/dL.
If the concentration is greater than linearity (300 mg/dL), dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
REFERENCE RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum/ Plasma : 10-50 mg/dL
Urine : 20-35 gm/24 hr
PREPARATION AND STABILITY OF WORKING REAGENT
Mix 4 volume of Reagent 1 (R1) with 1 volume of Reagent 2 (R2)
Working reagent is stable for 30 days at 2-80c.
Note
Discard the working reagent if the blank absorbance is less than 1.0 at 340 nm.
PRECAUTION
To avoid contamination useclean laboratory wares. Avoid direct exposure of reagent
to light.
SAMPLE
Serum, Plasma ( free of hemolyses). Do not use anticoagulants containing Fluoride
or Ammonium Ions.
Urine(1/100 diluted with distilled water (DI water). Multiply result with dilution factor.

ADL/V.02/February 2013

30
 2x30mL, 2x50mL, 2x100mL
URIC ACID (S.L) 11413004, 11413002, 11413003
INTENDED USE: GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of uric acid in serum, Mode of Reaction End point
plasma & urine.
Slope of reaction Increasing
- Uricase – PAP methodology
- Linear up to 25 mg/dL Wavelength I 546 nm (540 - 560)
- Fast incubation, just 5 minutes at 370C Wavelength II 630 nm
CLINICAL SIGNIFICANCE Temperature 370C
Uric acid is the end product of purine metabolism. Uric acid is excreted by the kidneys. Standard Concentration 8 mg/dL
Increased levels are found in Gout, arthritis, impaired renal functions & starvation. Blank Reagent
Decreased levels are found in yellow atrophy of the liver.
Incubation time 5 minutes
PRINCIPLE Linearity 25 mg/dL
Enzymatic determination of uric acid according to the following reactions.
Sample volume 25 µL
Uricase
Uric acid + 2H2O+O2 ---------- > Allantoine +CO2 +H2O2 Reagent volume 1000 µL
Peroxidase Cuvette 1 cm light path
2H2O2 + 4 -Aminoantipyrine +EHSPT ---------------- > Red quinone LABORATORY PROCEDURE
EHSPT = N-Ethyl N-(2-Hydroxy-3-Sulfoproyl) n-Toluidine Blank Standard Sample
Reagent 1000 µL 1000 µL 1000 µL
REAGENT COMPOSITION
Standard - 25 µL -
URIC ACID (S.L) R1 2 x 30 mL / 2 x 50 mL / 2 x 100 mL Sample - - 25 µL
Phosphate Buffer (pH 7.0) 100 mmol/L Mix and incubate 5 min. at 370C. Measure absorbance of sample and standard against
EHSPT 1.10 mmol/L the reagent blank.
Ferrocyanure 50 µmol/L CALCULATION
Amino-4-antipyrine 0.37 mmol/L Absorbance of Sample
Uricase > 140 U/L Uric Acid Con. (mg/dL) = ------------------------------- x 8
Peroxidase > 3000 U/L Absorbance of Standard
URIC ACID STANDARD 1 x 4 mL BIBLIOGRAPHY
Uric acid standard concentration 8 mg/dL Barham, D., Trinder; Analyst 97, 142(1972)
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 25 mg/dL.
If the concentration is greater than linearity (25 mg/dL), dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum / Plasma
Men : 3.4 - 7.0 mg/dL
Women : 2.4 - 5.7 mg/dL
PREPARATION AND STABILITY OF REAGENT
The reagent is ready to use
Note : Discard the reagent if the blank absorbance exceeds 0.3
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
SAMPLE
Serum / EDTA or Heparin plasma (free of haemolysis)

ADL/V.03/February 2013

31
 4 x 50 mL
ALBUMIN 11001003
INTENDED USE CALCULATION
This reagent is intended for in vitro quantitative determination of albumin in serum Absorbance of Sample
or plasma. Albumin Con. (g/dL) = -------------------------------- x 3
Absorbance of Standard
- Bromocresol green methodology
- Linear up to 6 g/dL BIBLIOGRAPHY
1. Doumasa, B.T., et al; Clin. Chim Acta 31, 87 pp (1971)
CLINICAL SIGNIFICANCE 2. Weis, W. A. ; Klin. Wochenschr. 43, S.273 (1965)
Albumin which is synthesized in the liver constitutes a major part of the total
proteins in the body, the other part being globulin, they form the major portion of
the dissolved substances in the plasma. Functions of albumin includes distribution
of extracellular fluid, regulation of osmotic pressure, acts as transport agent for a
wide variety of substance such as hormones, lipids, vitamins etc.
Increased levels are seen in dehydration.
Decreased levels are seen in liver disease (Hepatitis, Cirrhosis), malnutrition, kidney
disorders, increased fluid loss during extensive burns & malabsorption.
PRINCIPLE
The reaction between albumin from serum or plasma and the dye bromocresol-
green produces a change in colour that is proportional to the albumin concentration.
REAGENT COMPOSITION
ALBUMIN REAGENT 4 x 50 mL
Succinate Buffer (pH 4.20) 75 mmol/L
Bromocresol green 0.14 g/L
ALBUMIN STANDARD 1 x 3 mL
Albumin standard concentration 3 g/dL
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at room temperature & standard at 2 - 80C.
LINEARITY
This reagent is linear up to 6 g/dL.
If the concentration is greater than linearity (6 g/dL), dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum / plasma 3.5 – 5.5 g/dL
PREPARATION AND STABILITY OF REAGENT
Reagent and standard are ready to use.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
SAMPLE
Serum / plasma (free of haemolysis)
GENERAL SYSTEM PARAMETER
Mode of Reaction End point
Slope of reaction Increasing
Wavelength 630 nm
Temperature 30oC
Standard Concentration 3 g/dL
Linearity 6 g/dL
Blank Reagent
Incubation time 1 min
Sample volume 10 µL
Reagent volume 1000µL
Cuvette 1 cm light path
LABORATORY PROCEDURE
Blank Standard Sample
Reagent 1000 µL 1000 µL 1000 µL
Standard - 10 µL -
Sample - - 10 µL
Mix and incubate for 1 minute. Measure absorbance of standard & sample against
the reagent blank.

ADL/V.02/February 2013

32
 4 x 50 mL
BILIRUBIN DIRECT 11003003
INTENDED USE LABORATORY PROCEDURE
This reagent is intended for in vitro quantitative determination of Bilirubin in serum
or plasma .
- Linear up to 20 mg/dL Sample Blank Test
- Fast incubation 5 minutes at room temperature Direct bilirubin reagent 1000 µL 1000 µL
- Sample volume only 50 µL
- Without sample blank procedure also included Activator Direct - 20 µL
CLINICAL SIGNIFICANCE Serum 50 µL 50 µL
Bilirubin is formed by the break down of RBC’s in the spleen, liver & bone marrow. Mix well and incubate for 5 minutes at room temperature. Measure the absorbance
Small amount of bilirubin circulates in the plasma loosely bound to albumin, which of test against respective Blank at 546 nm.
is not water soluble. This is referred to as indirect or unconjugated bilirubin. In the
liver bilirubin is conjugated with glucuronic acid, which forms a soluble compound. CALCULATION
This is referred to a direct bilirubin.
With factor :
Elevated levels are found in Hepatitis, Cirrhosis, Haemolytic jaundice, obstruction of
biliary tract & drug induced reactions. Direct Bilirubin = OD of test – OD of sample blank x16
With calibrator :
PRINCIPLE OD of test –OD of sample blank
Sulfanilic acid reacts with sodium nitrite to form diazotized sulfanilic acid. Direct Bilirubin Concentration = ---------------------------------------- x concentration of std.
Bilirubin reacts with diazotized sulfanilic acid to form azobilirubin. OD of calibrator – OD of calibrator blank
REAGENT COMPOSITION
DIRECT BILIRUBIN REAGENT 4 x 50 mL Alternative Method – without sample blank
Sulfanilic acid 28.9 mmol/L GENERAL SYSTEM PARAMETER
Hydrochloric acid 165 mmol/L Mode of Reaction End point
Preservatives and stabilizers Slope of reaction Increasing
DIRECT BILIRUBIN ACTIVATOR 2 x 4 mL Wavelength I 546 nm
BILIRUBIN CALIBRATOR Wavelength II 630 nm
Not provided along with the Kit, recommended Agappe multicalibrator product code
: 11610001 Temperature 30oC
Factor (Direct ) 20.0
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored Blank Reagent
at RT. The standard & activator should be stored at 2 - 80C Linearity 20 mg/dL
LINEARITY Reaction time 5 min
This reagent is linear up to 20 mg/dL. Sample volume 50 µL
If the concentration is greater than linearity (20 mg/dL), dilute the sample with normal Reagent volume 1000 µL
saline and repeat the assay. Multiply the result with dilution factor.
Activator 20 µL
NORMAL RANGE Cuvette 1 cm light path
It is recommended that each laboratory establish its own reference values. LABORATORY PROCEDURE
The following value may be used as guide line.
Direct Bilirubin up to 0.4 mg/dL
PREPARATION AND STABILITY OF WORKING REAGENT Reagent Blank Test
Reagents are ready to use. Direct Bilirubin Reagent 1000 µL 1000 µL
PRECAUTION Activator Direct 20 µL 20 µL
To avoid contamination, use clean laboratory wares.
Serum / Calibrator - 50 µL
Avoid direct exposure of reagent to light.
SAMPLE Mix well and incubate for exactly 5 minutes. Measure the absorbance of calibrator
and test against reagent blank at 546/630 nm.
Serum / plasma (free of haemolysis)
GENERAL SYSTEM PARAMETER CALCULATION
Mode of Reaction End point With factor :
Direct Bilirubin = OD of test – OD of reagent blank x 20
Slope of reaction Increasing
With calibrator :
Wavelength 546 nm OD of test –OD of reagent of blank
Temperature 30oC Bilirubin Concentration = ------------------------------------------- x concentration of std.
Factor (Direct ) 16.0 OD of calibrator – OD of sample blank
Blank Sample blank BIBLIOGRAPHY
Linearity 20 mg/dL 1. Water, M., Gerard, H.; MICROCHEM JM 15, 231(1980)
2. Annino J. S.; C.C. Principles and procedure,1960
Reaction time 5 min 3. A.A. A.C.C.; Clin. Chem. 8 : 405,196
Sample volume 50 µL
Reagent volume 1000 µL
Activator 20 µL
Cuvette 1 cm light path

ADL/V.02/February 2013

33
 4 x 50 mL
BILIRUBIN TOTAL-TAB 11003005
INTENDED USE
This reagent is intended for in vitro quantitative determination of Bilirubin in serum LABORATORY PROCEDURE
or plasma.
- Modified TAB method
- Linear up to 25 mg/dL Sample Blank Test
- Fast incubation 5 minutes at room temperature
- Sample volume only 50 µL Total Bilirubin Reagent 1000 µL 1000 µL
- Without sample blank procedure also included Activator Total - 20 µL
CLINICAL SIGNIFICANCE Serum / Calibrator 50 µL 50 µL
Bilirubin is formed by the break down of RBC’s in the spleen, liver & bone marrow.
Small amount of bilirubin circulates in the plasma loosely bound to albumin, which Mix well and incubate for 5 minutes at room temperature. Measure the absorbance
is not water soluble. This is referred to as indirect or unconjugated bilirubin. In the of calibrator and test against respective Blank at 546 nm.
liver bilirubin is conjugated with glucuronic acid, which forms a soluble compound.
This is referred as direct bilirubin. CALCULATION
Elevated levels are found in Hepatitis, Cirrhosis, Haemolytic jaundice, obstruction of With factor :
biliary tract & drug induced reactions. Total Bilirubin = OD of test – OD of sample blank x 25
PRINCIPLE With calibrator :
Sulfanilic acid reacts with sodium nitrite to form diazotized sulfanilic acid. Total OD of test –OD of sample blank
Bilirubin reacts with diazotized sulfanilic acid in the presence of TAB form azobilirubin. Bilirubin Concentration = ---------------------------------------------- x Conc.of calib.
OD of calibrator – OD of calibrator blank
REAGENT COMPOSITION
Alternative Method – without sample blank
TOTAL BILIRUBIN REAGENT 4 x 50 mL
GENERAL SYSTEM PARAMETER
Sulfanilic acid 28.9 mmol/L
TAB 9 mmol/L Mode of Reaction End point
Preservatives and Stabilizers Slope of reaction Increasing
TOTAL BILIRUBIN ACTIVATOR 2 x 4 mL Wavelength I 546 nm
Wavelength II 630 nm
BILIRUBIN CALIBRATOR
Not provided along with the Kit, recommended Agappe multicalibrator product code Temperature 30 oC
: 11610001 Factor (Total ) 29
STORAGE AND STABILITY Blank Reagent blank
The sealed reagents are stable up to the expiry date stated on the label, when stored Linearity 25 mg/dL
at RT. The Calibrator & activator should be stored at 2 - 80C. Reaction time 5 min
LINEARITY Sample volume 50 µL
This reagent is linear up to 25 mg/dL. Reagent volume 1000 µL
If the concentration is greater than linearity (25 mg/dL), dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor. Activator 20 µL
Cuvette 1 cm light path
NORMAL RANGE
LABORATORY PROCEDURE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Total Bilirubin - up to 1.2 mg/dL Reagent Blank Test
PREPARATION AND STABILITY OF REAGENT Total bilirubin reagent 1000 µL 1000 µL
Reagents are ready to use.
Activator Total 20 µL 20 µL
PRECAUTION
To avoid contamination, use clean laboratory wares. Serum / Calibrator - 50 µL
Avoid direct exposure of reagent to light. Mix well and incubate for exactly 5 minutes.Measure the absorbance of calibrator and
SAMPLE test against reagent blank at 546/630 nm.
Serum/Plasma (free of haemolysis)
CALCULATION
GENERAL SYSTEM PARAMETER With factor :
Mode of Reaction End point Total Bilirubin = OD of test – OD of reagent blank x 29.00
Slope of reaction Increasing With calibrator :
Wavelength 546 nm OD of test – OD of reagent of blank
Bilirubin concentration = ----------------------------------------------- x conc. of calib.
Temperature 30 oC
OD of calibrator – OD of sample blank
Factor (Total ) 25
BIBLIOGRAPHY
Blank Sample blank
1. Walter, M., Gerard, H.; MICROCHEM JM 15, 231.(1980)
Linearity 25 mg/dL 2. Annino J. S.; C.C. Principles and procedure,1960
Reaction time 5 min 3. A.A. A.C.C.; Clin. Chem. 8 : 405,196
Sample volume 50 µL
Reagent volume 1000 µL
Activator 20 µL
Cuvette 1 cm light path

ADL/V.02/JAN 2013

34
 4 x 50 mL
BILIRUBIN TOTAL 11003002
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of Bilirubin in serum Mode of Reaction End point
or plasma.
Slope of reaction Increasing
- Modified DMSO method
- Linear up to 20 mg/dL Wavelength 546 nm/ 532 nm
- Fast incubation 5 minutes at room temperature Temperature 30 oC
- Sample volume only 50µL Factor (Total ) 20.5(546nm)/23.5 (532 nm)
CLINICAL SIGNIFICANCE Blank Sample blank
Bilirubin is formed by the break down of RBC’s in the spleen, liver & bone marrow. Linearity 20 mg/dL
Small amount of bilirubin circulates in the plasma loosely bound to albumin, which Reaction time 5 min
is not water soluble. This is referred to as indirect or unconjugated bilirubin. In the
liver bilirubin is conjugated with glucuronic acid, which forms a soluble compound. Sample volume 50 µL
This is referred as direct bilirubin. Reagent volume 1000 µL
Elevated levels are found in Hepatitis, Cirrhosis, Haemolytic jaundice, obstruction Activator 20 µL
of biliary tract & drug induced reactions.
Cuvette 1 cm light path
PRINCIPLE LABORATORY PROCEDURE
Sulfanilic acid reacts with sodium nitrite to form diazotized sulfanilic acid. Total
Bilirubin reacts with diazotized sulfanilic acid in the presence of DMSO to form Sample Blank Test
azobilirubin.
Total Bilirubin Reagent 1000 µL 1000 µL
REAGENT COMPOSITION
Activator Total - 20 µL
TOTAL BILIRUBIN REAGENT 4 x 50 mL
Serum / Calibrator 50 µL 50 µL
Sulfanilic acid 28.9 mmol/L
HCl 165 mmol/L Mix well and incubate for 5 minutes at room temperature. Measure the absorbance
DMSO 7 mmol/L of calibrator and test against respective Blank at 546 nm.
Preservatives and Stabilizers
CALCULATION
TOTAL BILIRUBIN ACTIVATOR 2 x 4 mL With factor :
BILIRUBIN ARTIFICIAL STANDARD 1 x 4 mL Total Bilirubin = OD of test – OD of sample blank x Factor
Total bilirubin standard concentration 10mg/dL
STORAGE AND STABILITY With artificial standard :
The sealed reagents are stable up to the expiry date stated on the label, when stored OD of test –OD of sample Blank
at RT. The standard & activator should be stored at 2 - 80C. Bilirubin Concentration = --------------------------------------- x 10
LINEARITY OD of standard
This reagent is linear up to 20 mg/dL. BIBLIOGRAPHY
If the concentration is greater than linearity (20 mg/dL), dilute the sample with normal 1. Walter, M., Gerard, H.; MICROCHEM JM 15, 231.(1980)
saline and repeat the assay. Multiply the result with dilution factor. 2. Annino J. S.; C.C. Principles and procedure,1960
3. A.A. A.C.C.: Clin. Chem. 8 : 405,19
REFERENCE RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Cord : 2.0 mg/dL
0-1 day : 1.4-8.7 mg/dL
1-2 days : 3.4-11.5 mg/dL
3-5 days : 1.5-12.0 mg/dL
Adult : 0.3-1.2 mg/dL
PREPARATION AND STABILITY OF REAGENT
Reagents are ready to use.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
SAMPLE
Serum/Plasma (free of haemolysis)

ADL/V.02/February 2013

35
 4 x 50 mL
BILIRUBIN TOTAL & DIRECT 11003001
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of Bilirubin in serum Mode of Reaction End point
or plasma.
Slope of reaction Increasing
- Modified DMSO/DIAZO method
- Linear up to 20 mg/dL Wavelength 546 nm/ 532 nm
- Fast incubation 5 minutes at room temperature Temperature 30 oC
- Sample volume only 50 µL
Factor (Total ) 20.5(546nm)/23.5 (532 nm)
CLINICAL SIGNIFICANCE
Factor (Direct) 16(546nm)/18 (532 nm)
Bilirubin is formed by the break down of RBC’s in the spleen, liver & bone marrow.
Small amount of bilirubin circulates in the plasma loosely bound to albumin, which Blank Sample blank
is not water soluble. This is referred to as indirect or unconjugated bilirubin. In the Linearity 20 mg/dL
liver bilirubin is conjugated with glucuronic acid, which forms a soluble compound.
This is referred as direct bilirubin. Reaction time 5 min
Elevated levels are found in Hepatitis, Cirrhosis, Haemolytic jaundice, obstruction Sample volume 50 µL
of biliary tract & drug induced reactions. Reagent volume 1000 µL
PRINCIPLE Activator 20 µL
Sulfanilic acid reacts with sodium nitrite to form diazotized sulfanilic acid. Total Cuvette 1 cm light path
Bilirubin reacts with diazotized sulfanilic acid in the presence of DMSO to form
azobilirubin.
LABORATORY PROCEDURE
REAGENT COMPOSITION Total Bilirubin Direct Bilirubin
TOTAL BILIRUBIN REAGENT 2 x 50mL Sample blank Test Sample blank Test
Sulfanilic acid 28.9mmol/L T.Bilirubin reagent 1000 µL 1000µL - -
HCl 165mmol/L D.Bilirubin reagent - - 1000 µL 1000 µL
DMSO 7mmol/L Activator (T/D) - 20 µL - 20 µL
Preservatives and Stabilizers Serum 50 µL 50 µL 50 µL 50 µL
TOTAL BILIRUBIN ACTIVATOR 2 x 4 mL Mix well and incubate for exactly 5 minutes. Measure the absorbance of the sample
against the respective sample blank at 546 or 532 nm.
DIRECT BILIRUBIN REAGENT 2 x 50 mL
CALCULATION
Sulfanilic acid 28.9 mmol/L
For semi auto with factor :
HCl 165 mmol/L
Total Bilirubin = OD of test – OD of sample blank x Factor
DIRECT BILIRUBIN ACTIVATOR 2 x 4 mL Direct Bilirubin = OD of test – OD of sample blank x Factor
BILIRUBIN ARTIFICIAL STANDARD 1 x 4 mL With artificial standard :
Total bilirubin standard concentration 10 mg/dL OD of test –OD of sample Blank
Direct bilirubin standard concentration 7.7 mg/dL Total Bilirubin Concentration = ------------------------------------------ x 10
STORAGE AND STABILITY OD of standard
The sealed reagents are stable up to the expiry date stated on the label, when stored
at RT. The standard & activator should be stored at 2 - 80C. OD of test –OD of sample Blank
Direct Bilirubin Concentration = ------------------------------------------ x 7.7
LINEARITY OD of standard
This reagent is linear up to 20 mg/dL.
If the concentration is greater than linearity (20 mg/dL), dilute the sample with normal BIBLIOGRAPHY
saline and repeat the assay. Multiply the result with dilution factor. 1. Walter, M., Gerard, H.; MICROCHEM J M 15, 231.(1980)
2. Annino J. S.; C.C. Principles and procedure, 1960.
NORMAL RANGE 3. A.A. A.C.C.; Clin. Chem. 8 : 405,19
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Total Bilirubin - up to 1.2 mg/dL
Direct bilirubin up to 0.4 mg/dL
PREPARATION AND STABILITY OF REAGENT
Reagents are ready to use.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
SAMPLE
Serum/Plasma (free of haemolysis)

ADL/V.02/JAN 2013

36
 4 x 25 mL, 4 x 50 mL
CALCIUM 11005001, 11005002
INTENDED USE
This reagent is intended for in vitro quantitative determination of calcium in serum, LABORATORY PROCEDURE
plasma & urine. Blank Standard Sample
- Modified OCPC methodology Working Reagent 1000 µL 1000 µL 1000 µL
- Linear up to 15 mg/dL Standard - 10 µL -
CLINICAL SIGNIFICANCE Sample - - 10 µL
Calcium is an important ion present in the body. Mainly it is found in bones. In serum Mix and incubate for 5 min. at room temperature. Read the absorbance of standard
calcium exists equally in a free ionized form & also in a bound form with albumin. and sample against reagent blank.
Calcium helps in enzyme activation, muscle contraction, coagulation of blood, CALCULATION
regulation of some hormonal secretions & cell membrane permeability. Absorbance of sample
Increased levels are found in hyperthyroidism, malignant tumors, acute osteoporosis Calcium Conc. (mg/dL) = --------------------------------- x 10
& adrenal insufficiency.
Absorbance of Standard
Decreased levels found in hypoparathyrodism, osteomalacia, rickets, renal failure &
tetanus. INTERFERENCE
PRINCIPLE Bilirubin concentrations higher than 20 mg/dL and phosphate higher than 40 mg/dL,
will interfere with the assay.
Calcium OCPC procedure is based on on the reaction of calcium ions (Ca 2++) with O-
cresolphthalein complex in an alkaline solution to form an intense violet coloured BIBLIOGRAPHY
complex which shows maximum absorbance at 578nm. the 8-hydroxy quinoloine 1. Schwarzenbach, G.; Analyst., 80, (1955) 713-729
prevents Mg2++ interference upto 4 mmol/L. 2. Kessler, G., Wolfman, M., Clin.Chem., 10, (1964) 686 – 703
REAGENT COMPOSITION 3. Connerty, H. V., Briggs, A.R., Am. J. Clin.Pathol., 45, (1965) 290-296
4. Gitelmann, H. J. Anal Biochem 18, (1967) 521-531
CALCIUM DYE REAGENT (R2) 2 x 25 mL / 2 x 50 mL 5. Biggs, H.G., Moorehead, W. R.; Clin.Chem., 20, (1974) 1458-1460
Diethylamine 360 mmol/L
CALCIUM BASE REAGENT (R1) 2 x 25 mL / 2 x 50 mL
O-Cresolphthalein complex 0.15 mmol/L
8-Hydroxyquinoline 17.2 mmol/L
CALCIUM STANDARD 1 x 4 mL
Calcium standard concentration 10 mg/dL
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 15 mg/dL.
If the concentration is greater than linearity (15 mg/dL), dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum : 8.8 - 10.2 mg/dL
Urine : 100 - 400 mg/24 hrs
PREPARATION AND STABILITY OF REAGENT
Mix reagent 1 (R1) and Reagent 2 (R2) in the ratio 1:1.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
(Use acid washed (50 % HNO3) glass wares & tips)
SAMPLE
Serum / plasma (free of haemolysis) / Urine (1/3 diluted)
GENERAL SYSTEM PARAMETER
Mode of Reaction End point
Slope of reaction Increasing
Wavelength 578 nm (565-580 nm)
Temperature 30 oC
Standard Concentration 10 mg/dL
Linearity 15 mg/dL
Blank Reagent
Incubation time 5 min
Sample volume 10 µL
Reagent volume 1000 µL
Cuvette 1 cm light path

ADL/V.02/February 2013

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 4 x 25 mL
CALCIUM (ARSENAZO) 11006001
INTENDED USE LABORATORY PROCEDURE
This reagent is intended for in vitro quantitative determination of calcium in serum, Blank Standard Sample
plasma & urine. Working Reagent 1000 µL 1000 µL 1000 µL
- Modified Arsenazo III method Standard - 10 µL -
- Linear up to 18mg/dL Sample - - 10 µL
CLINICAL SIGNIFICANCE Mix and incubate for 1 minute. Measure the absorbance of standard and sample
Calcium is an important ion present in the body. Mainly it is found in bones. In serum against reagent blank.
calcium exists equally in a free ionized form & also in a bound form with albumin. CALCULATION
Calcium helps in enzyme activation, muscle contraction, coagulation of blood, Absorbance of sample
regulation of some hormonal secretions & cell membrane permeability.
Calcium Conc. (mg/dL) = ------------------------------- x 10
Increased levels are found in hyperthyroidism, malignant tumors, acute & osteoporosis
adrenal insufficiency. Absorbance of Standard
Decreased levels found in hypoparathyrodism, osteomalacia, rickets, renal failure & BIBLIOGRAPHY
tetanus. Baver, P. J.; Anal. Biochem., 110, (1981), 61
PRINCIPLE Biggs, H.G., Moorchand, W.R., (1974), cLIN. CHEM. 20, 1458-1460.
At a neutral pH the Ca2+ form with Arsenazo III a complex, the color intensity of which
is directly proportional to the concentration of calcium in the sample.
REAGENT COMPOSITION
CALCIUM ARSENAZO REAGENT 4 x 25 mL
MES, pH 6.50 100 mmol/L
Arsenazo III 200 mmol/L
CALCIUM ARSENAZO STANDARD 1 x 4 mL
Calcium Standard Concentration 10 mg/dL
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 18 mg/dL.
If the concentration is greater than linearity (18mg/d/L), dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum / plasma : 8.8 - 10.2 mg/dL
PREPARATION AND STABILITY OF WORKING REAGENT
The Reagent is ready to use.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
NOTE: Use acid washed (50% HNO3) glass wares & tips.
SAMPLE
Serum / plasma (free of haemolysis)
Take dilution factor into account for the calculation of the concentration in urine.
GENERAL SYSTEM PARAMETER
Mode of Reaction End point
Slope of reaction Increasing
Wavelength 630 or 650 nm
Temperature RT
Standard Concentration 10 mg/dL
Linearity 18 mg/dL
Blank reagent
Incubation time 1 min
Sample volume 10 µL
Reagent volume 1000 µL
Cuvette 1 cm light path

ADL/V.02/February 2013

38
 4 x 50 mL
CHLORIDE 11007001
INTENDED USE LABORATORY PROCEDURE
This reagent is intended for in vitro quantitative determination of Chloride in serum, Blank Standard Sample
plasma & urine. Reagent 1000 µL 1000 µL 1000 µL
- Modified Thiocyanate method Standard - 10 µL -
- Linear up to 130 mEq/L Sample - - 10 µL
CLINICAL SIGNIFICANCE Mix and incubate for 1 min. Measure the absorbance of standard and sample against
Chloride & bicarbonate are the principle anions (-vely charged) whereas sodium & reagent blank.
potassium are the principle cations (+vely charged) in the plasma. Chloride ions are CALCULATION
involved in regulation of water distribution between the tissues by maintaining Absorbance of sample
osmotic pressure & normal cation and anion balance between intra & extra cellular
fluids. Chloride conc. (mEq/L) = ------------------------------ x 100
Elevated levels are seen in conditions like dehydration & congestive cardiac failure. Absorbance of Standard
Decreased levels are seen in condition such as salt losing nephritis, diabetic acidosis BIBLIOGRAPHY
& renal failure. Schonfeld, R. G., Lowellen, C. S.; Clin. Chem. 10, 533 pp (1964)
PRINCIPLE
In an acid medium chloride ions and mercury – II – thiocynate form thiocynate ions.
These ions react with HNO3 and iron-III-ions and effect a red color. The intensity of
the color is directly proportional to the concentration of chloride ions.
REAGENT COMPOSITION
CHLORIDE REAGENT 4 x 50 mL
Mercuric (II) thiocyanate 2 mmol/L
Nitric acid 29 mmol/L
Ferric Nitrate 20 mmol/L
CHLORIDE STANDARD 1 x 4 mL
Chloride standard concentration 100 mEq/L
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at room temperature & standard at 2 - 80C.
LINEARITY
This reagent is linear up to (130 mEq/L).
If the concentration is greater than linearity (130 mEq/L), dilute the sample with
Distilled water and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guideline.
Serum : 97 - 108 mEq/L
Urine : 120 - 240 mEq/L/24 hr
PREPARATION AND STABILITY OF REAGENT
The Reagent is ready to use.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
SAMPLE
Serum / plasma (free of haemolysis) / Urine (Dilute sample 1:1 with distilled water and
multiply the result with 2)
GENERAL SYSTEM PARAMETER
Mode of Reaction End point
Slope of reaction Increasing
Wavelength 505 nm (480-550nm)
Temperature RT
Standard Concentration 100 mEq/L
Linearity 130 mEq/L
Blank Reagent
Reaction time 1 min
Sample volume 10 µL
Reagent volume 1000 µL
Cuvette 1 cm light path

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 2 x 25 mL
COPPER 11020001
INTENDED USE Sample volume 70 µL
This reagent is intended for in vitro quantitative determination of Copper in serum. Reagent volume 1000 µL
CLINICAL SIGNIFICANCE Cuvette 1 cm light path
Copper is an essential trace mineral in humans, the function of copper is to help to LABORATORY PROCEDURE
release energy, helps in melanin production in the skin, helps in the production of Blank Standard Sample
red blood cells and aid in the absorption and transport of iron.
WorkingReagent 1000 µL 1000 µL 1000 µL
Acquired copper deficiency can cause hematological/neurological manifestations.
Wilson disease (copper toxicity) is associated with neurological manifestations and Distilled water 70 µL - -
low serum copper, with copper deposited in tissues responsible for the toxicity. The Standard - 70 µL -
symptoms of acute copper poisoning include nausea, vomiting and abdominal and
muscle pain. Sample - - 70 µL
Mix and incubate for 10 minutes at 30oC. Read the absorbance(A) of standard and
PRINCIPLE sample against blank at 580 nm. The colour is stable for 30 minutes.
Copper in an acid medium reacts with the chromogen Di-Br-PAESA 4-(3,5-dibromo-
2- pyridylazo)-N-ethyl-N-(3-sulphopropyl0aniline.) to form a coloured complex. CALCULATION
Intensity of the colour is directly proportional to the amount of Copper present in Absorbance of Sample
the sample. Copper µg/dL = -------------------------------- x 200
REAGENT COMPOSITION Absorbance of Standard
COPPER REAGENT 1 1 x 25 mL BIBLIOGRAPHY
Acetate buffer(pH 4.9) 0.1 M 1. Pasquinelli, F.; Diagnostica e Tecniche di Laboratorio, (pag.:1099-1102) Rossini
Editrice.(1984)
COPPER REAGENT 2 1 x 25 mL 2. Akitaabe, Sumico Yiamashita; Clin. Chem. 35(4):197,552-554(1989)
3,5 Di-Br-PAESA 3. Cuiti, R, Gallia, Giorn.; It. Chim. Clin. 12(2): 91-100 (1987)
Preservatives
COPPER STANDARD 1 x 4 mL
Copper Standard (Concentration) 200 µg/dL
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2-80C.
Note:Reagent 1 solidifies when kept at 2-8oC. Allow the reagent to melt by keeping at
room temperature before use.
LINEARITY
This reagent is linear up to 500 µg/dL.
If the concentration is greater than linearity (500 µg/dL), dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
REFERENCE VALUES
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Men : 70 - 140 µg/dL
Women : 80- 155 µg/dL
Newborns : 20- 70 µg/dL
Children up to 6 years : 90-190 µg/dL
Children up to 12 years : 80-160 µg/dL
PREPARATION OF WORKING REAGENT
Mix in equal parts the reagent 1 & reagent 2 .
PRECAUTION
To avoid contamination, use clean laboratory wares. It is recommended to use
disposable tubes. Use clean, dry disposable pipette tips for dispensing. Close reagent
and standard bottles immediately after use. Avoid direct exposure of reagent to light.
Note: Use acid washed (50% HNO3) glass wares and tips.
SAMPLE
Serum or Plasma (free haemolysis). Use heparin as anticoagulant.Highly lipemic serum
may interfere the assay. it is recommended to filter or centrifuge the sample
GENERAL SYSTEM PARAMETER
Mode of Reaction End Point
Slope of reaction Increasing
Wavelength 580 nm
Temperature 30 oC
Standard concentration 200 µg/dL
Linearity 500 µg/dL
Blank Reagent Blank
Incubation Time 10 min

40
 4 x 50 mL
CREATININE 11009001
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of creatinine in serum, Mode of Reaction Fixed time
plasma & urine.
Slope of reaction Increasing
- Modified Jaffe’s method
- Linear up to 24 mg/dL Wavelength 492 nm/ 505 nm
- No Bilirubin interference up to 10 mg/dL Temperature 370C
CLINICAL SIGNIFICANCE Standard Concentration 2 mg/dL
Creatinine is formed in muscles from phospho creatinine. It is an important form of Linearity 24 mg/dL
energy, being a store of high-energy phosphate. Creatinine determinations have one Blank D I water
advantage over Urea determination that it is not affected by a high protein diet.
Delay time 60 sec
Serum creatinine is more specific & sensitive indicator of renal function. Simultaneous
estimations of serum urea & creatinine provides better information. Serum urea Interval 60 sec
nitrogen, creatinine ratio is > 15 in pre renal failure, & < 10 in renal failure. Sample volume 100 µL
Decreased levels are found in muscle dystrophy. Reagent volume 1000 µL
PRINCIPLE Cuvette 1 cm light path
Creatinine reacts with picric acid to produce a colored compound, creatinine alkaline
picrate. The change in absorbance is proportional to the creatinine concentration. LABORATORY PROCEDURE
Standard Sample
REAGENT COMPOSITION
CREATININE BASE REAGENT (R1) 2 x 50 mL Working Reagent 1000 µL 1000 µL
Sodium hydroxide 300 mmol/L Standard 100 µL -
Sodium Phosphate 25 mmol/L Sample - 100 µL
Mix and read the optical density (T 1) 60 seconds after the sample or standard
CREATININE DYE REAGENT (R2) 2 x 50 mL addition. Exactly 60 seconds after the first reading take second reading (T2)
Picric Acid 8.73 mmol/L CALCULATION
Surfactant (T2- T1) of sample
CREATININE STANDARD 1 x 4 mL Creatinine conc. (mg/dL) = ---------------------- x 2
Creatinine standard concentration 2 mg/dL (T2- T1) of Standard

STORAGE & STABILITY BIBLIOGRAPHY

The sealed reagents are stable up to the expiry date stated on the label, when stored 1. Allen, L.C.; Clin chem. Vol.28 No.3, 1982, 555.
at room temperature & standard at 2 - 80C. 2. Haeckel, R., et al. ; Clin. Chem. 27/1 179-183 (1981).
3. Tanganelli, E., Prencipe,L. , Bassi, D., Cambiaghi, S. and Murador, E.; Clin.Chem
LINEARITY 28/7, 1461-1464 (1982)
This reagent is linear up to 24 mg/dL.
If the concentration is greater than linearity (24 mg/dL), dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum : Men : 0.7 – 1.4 mg/dL
Female : 0.6 – 1.2 mg/dL
Urine : 0.80 – 1.80 gm/24 hour
PREPARATION AND STABILITY OF WORKING REAGENT
Mix 1 volume of Reagent 1 (R1) with 1 volume of Reagent 2 (R2).
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
SAMPLE
Serum / plasma (free of haemolysis) / Urine (diluted 1/100 with distilled water)

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41
 1 x 1000 mL
HAEMOGLOBIN 11011001
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of Haemoglobin in Mode of Reaction End point
blood.
Slope of reaction Increasing
- Based on cyanmethaemoglobin method
- Linear up to 20 gm/dL Wavelength 546nm (530-550nm)
Temperature 30oC
CLINICAL SIGNIFICANCE
A decrease in haemoglobin below normal range is an indication of anaemia. An increase Blank Reagent
in haemoglobin concentration occurs in haemoconcentration due to loss of body Linearity 20 gm/dL
fluid in severe diarrhea and vomiting. High values are also observed in congenital heart Standard concentration 15 gm /dL (60x0.251)
disease (due to reduced oxygen supply) in emphysema and also in poly cythemia.
Haemoglobin concentration drops during pregnancy due to haemodilution Incubation time 5 min
Sample volume 20 µL
PRINCIPLE
The Haemoglobin (oxyhaemoglobin,methemoglobin, Carboxyhaemoglobin) is Reagent volume 5000 µL
converted to cyanmethaemoglobin according to the following reactions. Cuvette 1 cm light path
K3 Fe(CN)6 *NOTE : Analyzer users directly enter given Factor without running standard.
Haemoglobin --------------- > Methemoglobin Factor 35
KCN
LABORATORY PROCEDURE
Methemoglobin --------------- > cyanmethemoglobin
Blank Sample
The intensity of the color is proportional to haemoglobin concentration and is
compared to known cyan methaemoglobin standard at 540 nm (green filter). Hb Reagent 5000 µL 5000 µL
Sample - 20 µL
REAGENT COMPOSITION Mix well and incubate at room temperature for 5 minutes. Measure the absorbance
HAEMOGLOBIN REAGENT 1000 mL of sample against reagent blank and measure the absorbance of standard directly
Potassium Phosphate 2.0 mmol/L against blank (distilled water).
Potassium ferricyanide 0.60 mmol/L CALCULATION
Potassium cyanide 0.90 mmol/L
Sodium chloride 1.4 mmol/L Haemoglobin Conc. (gm/dL) =
HAEMOGLOBIN STANDARD 1 x 4 mL Absorbance of sample
Cyanmethaemoglobin standard con. 60 mg/dL ---------------------------- x 60 x 0.251
Absorbance of standard
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored Dilution factor
at room temperature & standard at 2 - 80C.
Where, 0.251 = ------------------
LINEARITY Convertion factor
This reagent is linear up to 20 gm/dL.
REFERENCE RANGE OR
It is recommended that each laboratory establish its own reference values. Absorbance of sample
The following value may be used as guide line. -------------------------------- x 15
Cord blood :13.5 - 20.5 gm/dL Absorbance of standard
0.5 - 2.0 yrs :11.3 - 14.1 gm/dL
Male :13.2 - 17.3 gm/dL 15 = 60 x 0.251
Female :11.7 - 15.3 gm/dL BIBLIOGRAPHY
PREPARATION AND STABILITY OF REAGENT 1. Drabkin, D.L., et al.; J.Bio.Chem, 98 (1932), 719
The reagent is ready to use.‘ 2.. Zijlstra, N. C.; Clin.Chem.Acta, 5,(1960) 719
3. Tietz Text book of Clin Chem.Carl.AB,Edward.R.A,3rd Edition 1999
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light. Do not pipette the reagent with mouth.
SAMPLE
Fresh whole blood.

ADL/V.02/Jan 2013

42
 4 x 25 mL
HDL CHOLESTEROL 11010001
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of HDL in serum or Mode of Reaction End point
plasma.
Slope of reaction Increasing
- Precipitation method, Phosphotungstate magnesium acetate reagent
Wavelength I 505 (500 -532 nm)
- Linear up to 125 mg/dL
Wavelength II 630 nm
CLINICAL SIGNIFICANCE Temperature 370C
Lipoproteins are the proteins, which mainly transport lipids in the blood stream. They
are (HDL) High density lipoproteins, (LDL) Low density lipoproteins, (VLDL) Very low Standard Concentration 50 mg/dL
density lipoproteins & chylomicrons. LDL carries cholesterol to the peripheral tissues Blank Cholesterol Reagent
where it can be deposited & increase the risk of atherosclerotic heart & peripheral Linearity 125 mg/dL
vascular disease. Hence high levels of LDL are atherogenic. HDL transports cholesterol
from peripheral tissues to the liver & then for excretion, hence HDL has a protective Incubation time 5 min
effect. Hence the determination of serum HDL cholesterol is a useful tool to identify Sample volume 50 µL
patients at risk of developing coronary heart disease. Reagent volume 1000 µL
PRINCIPLE Cuvette 1 cm light path
The chylomicrons, Very low density lipoproteins (VLDL) and Low density lipoproteins LABORATORY PROCEDURE
(LDL) of serum are precipitated by phosphotungstic acid and magnesium ions.
1. PRECIPITATION
After centrifugation, High density lipoproteins (HDL) are in the supernatant. HDL
content of supernatant is measured by an enzymatic Method. Sample 300 µL
HDL reagent 300 µL
REAGENT COMPOSITION Mix well, allow to stand for 10 min. at room temperature, mix again and centrifuge
HDL CHOLESTEROL R1 4 x 25 mL for 10 min, at 4000 rpm.
Phosphotungstate 14 mmol/L After centrifugation separate the clear supernatant from the precipitate within 1 hour
Magnesium Chloride 1 mmol/L and determine the HDL Cholesterol concentration using the cholesterol reagent.
Preservative
2. HDL CHOLESTEROL DETERMINATION :
HDL CHOLESTEROL STANDARD 1 x 4 mL Blank Standard Sample
HDL Cholesterol concentration 50 mg/dL Cholesterol Reagent 1000 µL 1000 µL 1000 µL
STORAGE & STABILITY Standard(HDL) - 50 µL -
The sealed reagents are stable up to the expiry date stated on the label, when stored HDL supernatant - - 50 µL
at 2 - 80C. Mix and incubate for 5 min. at 370C. Measure the absorbance of the standard &
LINEARITY sample against the reagent blank.
The reagent is linear up to 125 mg/dL. CALCULATION
If the concentration is greater than linearity (125 mg/dL), dilute the sample with normal HDL Cholesterol Conc. In mg/dL =
saline and repeat the assay. Multiply the result with dilution factor. Absorbance of sample
NORMAL RANGE ------------------------------------ x concentration of standard x 2
It is recommended that each laboratory establish its own reference values. Absorbance of standard
The following values may be used as guide line.
where, 2 = dilution factor of the sample.
HDL Cholesterol
Men : 35-55 mg/dL LDL-Chol conc in mg/dL = Total Cholesterol – (HDL Chol. + Triglycerides / 5)
Women : 45-65 mg/dL
BIBLIOGRAPHY
LDL Cholestrol 1. Assmann, G.; Intermist 20 (1979), 559
Suspicious : 150 mg/dL 2. Gordon, T., et al.; Med 62 (1977), 707
Elevated : 190 mg/dL 3. Friedewald, W. T., et al.; Clin.Chem.18 (1972), 499.
PREPARATION AND STABILITY OF REAGENT
Reagent is ready to use.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
SAMPLE
Serum / Plasma (free of haemolysis).

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 4 x 25 mL, 4 x 50 mL
INORGANIC PHOSPHOROUS 11012001, 11012002
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of Phosphorous in Mode of Reaction End point
serum or plasma.
Slope of reaction Increasing
- Phosphomolybdate methodology
- Linear up to 15 mg/dL Wavelength 340 nm
Temperature 370C
CLINICAL SIGNIFICANCE
Phosphorous is mainly combined with calcium & is found in bones. It is involved in Standard Concentration 5 mg/dL
the carbohydrate metabolism & is a component of many other substances. Some of Linearity 15 mg/dL
its important functions include maintaining of acid-base balance, skeletal muscle Blank Reagent
formation. It is also required for normal functioning of RBC’s & muscles.
Increased levels are found in hypothyroidism, renal failure, bone metastasis & liver Reaction Time 1 min
disease. Sample volume 20 µL
Decreased levels are found in hyperparathyroidism, osteomalacia & disease associated Reagent volume 1000 µL
with Vitamin D defieciency.
Cuvette 1 cm light path
PRINCIPLE LABORATORY PROCEDURE
Determination of inorganic phosphorous according to the following reaction. Blank Standard Sample
Phosphorous Reagent 1000 µL 1000 µL 1000 µL
Ammonium molybdate +sulfuric acid ------------------->phosphomolybdic complex Standard - 20 µL -
REAGENT COMPOSITION Sample - - 20 µL
Mix & incubate at RT for 5 minutes. Read the absorbance of sample and standard
INORGANIC PHOSPHOROUS REAGENT 4 x 25 mL / 4 x 50 mL against reagent blank.
Sulfuric acid 210 mmol/L
Ammonium molybdate 650 mmol/L CALCULATION
Absorbance of sample
INORGANIC PHOSPHOROUS STANDARD 1 x 4 mL Phosphorous Conc. (mg/dL) = ------------------------------ x 5
Phosphorous standard concentration 5 mg/dL Absorbance of standard
STORAGE & STABILITY BIBLIOGRAPHY
The sealed reagents are stable up to the expiry date stated on the label, when stored 1. Tietz, N., Clinical Guide to Laboratory Tests, W.B. Saunders Company, Philad, 1983,
at 2 80C. 384
LINEARITY 2. Henry, R.J.; Clin. Chem., Harper & Row Publishers. New Yoork 1974
This reagent is linear up to 15 mg/dL. 3. Thomas, L.; Labor and Diagnose, 2 Aufl. Med.Vert. Gem. Marburg 1979 4.
Taussky, H.H., Schorr, E.; J.Biol. Chem 202, 675 (1953)
If the concentration is greater than linearity (15 mg/dL), dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum : 2.7 - 4.5 mg/dL
Urine : 400 - 1300 mg/24 hr.
PREPARATION AND STABILITY OF REAGENT
Reagent and standard are ready to use.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
NOTE: Use acid washed (50% HNO3) glasswares & tips.
SAMPLE
Serum / Plasma (free of haemolysis) / Urine (diluted 1/10 with distilled water).

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 2 x 50 mL
IRON 11022001
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of Iron in serum. Mode of Reaction End Point
Iron Chromazurol method Slope of reaction Increasing
Linearity- 500 µg/dL
Wavelength 630 nm
CLINICAL SIGNIFICANCE Temperature 30 oC
In the blood iron is present in the hemoglobin of erythrocytes. Major function of iron
in the body is the transportation of oxygen to the cells and cellular oxidation. Iron Standard concentration 200 µg/dL
absorbed in the small intestine and bound to a globulin in the plasma called transferrin. Linearity 500 µg/dL
It is then transported to bone marrow where RBC generation take place. Blank Ragent Blank
Increased levels of iron in serum are seen in hemolytic aneamia, hepatitis and lead &
iron poisoning. Incubation Time 10 min
Deceased levels are found in iron deficiency anemia, late pregnancy and cancer. Sample volume 40 µL
PRINCIPLE Reagent volume 1000 µL
Iron, bound to Transferrin in Fe(III) form, is released in an acidic medium and the Ferric Cuvette 1 cm light path
ions are reduced to Ferrous ions. The Fe (II) ions react with LABORATORY PROCEDURE
Cromazurol B to form an intensely coloured complex. Intensity of the colour Blank Standard Sample
formed is directly proportional to the amount of Iron present in the Reagent 1000 µL 1000 µL 1000 µL
sample. Distilled water 40 µL - -
REAGENT COMPOSITION Standard - 40 µL -
Sample - - 40 µL
IRON REAGENT 2 x 50 mL Mix and incubate for 10 minutes at room temperature. Read the absorbance(A) of
Acetate Buffer (pH 4.7) 0.2 mol/L standard and sample against blank at 630 nm. The colour is stable for 1 hour when
CTMA Bromide 0.7 mmol/L protected from light.
Cromazurol B 2 mmol/L CALCULATION
IRON STANDARD 1 x 4 mL Absorbance of Sample
Iron Standard (Concentration) 200 µg/dL Iron µg/dL = -------------------------------- x 200
STORAGE AND STABILITY Absorbance of Standard
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 -80C. BIBLIOGRAPHY
LINEARITY 1. Weippl, G., et al: Blut.27.261 (1973)
This reagent is linear up to 500 µg/dL. 2. Garcic, A. ; Clin, chem, Acta 94,115 (1979)
3. Tobacco, A., et al; Chem. Clin. Acta 114, 267 (1981)
If the concentration is greater than linearity (500 µg/dL), dilute the sample with normal 4. Teruzzi, A. , Torelli, G. ; 17th Meeting S.I. Bio.C.Clin.9,1080,communication (1985)
saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum Iron (Males) : 59 - 158 µg/dL
(Females) : 37 - 145 µg/dL
PREPARATION AND STABILITY OF REAGENT
Ready to use reagent.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
Note: Use acid washed (50% HNO3) glass wares and tips.
SAMPLE
serum

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45
 4 x 25 mL
MAGNESIUM 11019001
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of Magnesium in serum Mode of Reaction End point
or plasma.
Slope of reaction Increasing
- Xylidyl Blue with ATCS
- Linear up to 5 mg/dL Wavelength 546 nm ( 520-550 nm)
Temperature 370C
CLINICAL SIGNIFICANCE
Magnesium is the second most abundant intracellular cation of the human body after Standard Concentration 2 mg/dL
potassium, being essential in a great number of enzymatic and metabolic processes. Linearity 5 mg/dL
It is a co-factor of all the enzymatic reactions that involve ATP and found in the Blank Reagent
membranes that maintain the electrical excitability of muscular and nervous cells.
Incubation time 5 min
A low magnesium level is found in malabsorption syndrome, diuretics aminoglucoside
therapy, and hyperparathyroidism or diabetic acidosis. Sample volume 10 µL
Elevated concentration of magnesium is found in uremia, chronic renal failure, Reagent volume 1000 µL
glomerulo nephritis, Addison’s disease or intensive anti acid therapy. Cuvette 1 cm light path
Clinical diagnosis is should not be made on a single test result; it should integrate LABORATORY PROCEDURE
clinical and other laboratory data.
Blank Standard Sample
PRINCIPLE Reagent 1 1000 µL 1000 µL 1000 µL
Magnesium reacts with xylidyl Blue to form a colored compound in alkaline solution. Standard - 10 µL -
The intensity of the color formed is proportional to the magnesium in the sample. Sample - - 10 µL
REAGENT COMPOSITION Mix & incubate for 5 minutes at 370C. Read the absorbance of sample and standard
against reagent blank.
MAGNESIUM REAGENT 4 x 25 mL
Xylidyl Blue 110mmol/L CALCULATION
Ethanolamine (pH 11.0) 1 mol/L Magnesium Conc. (mg/dL) =
GEDTA 60 mmol/L Absorbance of sample
----------------------------- x Standard concentration
MAGNESIUM STANDARD 1 x 3 mL Absorbance of standard
Magnesium standard concentration 2 mg/dL
Unit Conversion
STORAGE AND STABILITY mg/dL x 0.4114 = mmol/L
The sealed reagents are stable up to the expiry date stated on the label, when stored mg/dL x 0.82 = mEq/L
at 2-80C, protected from light.
BIBLIOGRAPHY
LINEARITY
1. Farrel, E. C.; Magnesium.in Kaplan, A., et al.; Clin chem. The CV Mosby Co. St. Louis,
This reagent is linear up to 5 mg/dL. Torento, Princeton 1984; 1064-69
If the concentration is greater than linearity (5 mg/dL), dilute the sample with normal 2. Brutis, C. A., et al. TIETZ Text book of Clinical chemistry, 3 rd edition W. B Saunders
saline and repeat the assay. Multiply the result with dilution factor. company; 1999, P.1395-1457
NORMAL RANGE 3. Young, D. S.; Effects of disease on clinical lab tests, 4th edition, AACC Press,
2001.
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum : 1.8 – 2.6 mg/dL
CSF : 2.1 – 3.3 mg/dL
Urine : 73 - 122 mg/24 h
PREPARATION AND STABILITY OF REAGENT
Reagent is ready to use.
PRECAUTION
To avoid contamination, use clean laboratory wares. It is recommended to use
disposable tubes. Use clean, dry disposable pipette tips for dispending. Close reagent
and standard bottles immediately after Use. Avoid direct exposure of reagent to light.
SAMPLE
Serum (free haemolysis) / Heparinized plasma (Do not use oxalates or EDTA as
anticoagulant) / Urine (should be acidified to pH 3-4 with concentrated HCL then
dilute sample 1/5 with distilled water and multiply the result by 5).

ADL/V.02/February 2013

46
 1 x 50 mL
MICROPROTEIN 11021001
INTENDED USE LABORATORY PROCEDURE
This reagent is intended for in vitro quantitative determination of total protein in urine. Blank Standard Sample
- Pyrogallol Red method Reagent 1000 µL 1000 µL 1000 µL
- Linear up to 500 mg/dL Distilled water 10 µL - -
- Sensitivity of 5 mg/dL Standard - 10 µL -
Sample - - 10 µL
CLINICAL SIGNIFICANCE
Accurately mix and, after 5 minutes, read the absorbance of standard and sample
The presence of protein in urine is a very sensitive indicator of renal disorders. There against blank at 600 nm. The colour is stable for 30 minutes.
are four ways by which increased amounts of protein can occur:increased glomerular
permeability; defective tubular re-absorption; increased plasma concentration of an CALCULATION
abnormal, low molecular weight protein; and abnormal secretion of protein into the
urinary tract. urine:
Albuminuria, increased amounts of albumin in urine, has been recognized as an early A sample
indicator of renal damage in diabetes that can be reversed if detected and treated early. Proteins, mg/dL = -------------- x 100
A standard
PRINCIPLE
Proteins,in an acidic medium, combine with Pyrogallol Red and molybdate to form a Urine 24hrs:
blue purple coloured complex. The intensity of colour formed is directly proportional
to the amount of proteins present in the sample. A sample x1000 x T.V in litres
Proteins + Pyrogallol Red + Molybdate ----------> Blue purple coloured Complex Proteins, mg/24 hrs = ---------------------------------
REAGENT COMPOSITION A standard
MICROPROTEIN REAGENT 1 x 50 mL
Succinate buffer, pH 2.5 0.05 mmol/L T.V = Total volume of 24 hr urine in milliitres
Sodium dodecylsulphate 0.07 mmol/L BIBLIOGRAPHY
Sodium molybdate 0.04 mmol/L Watnabe, N., et al.; Urinary protein as measured with a pyrogallol red-molibdate
Pyrogallol-Red 0.06 mmol/L complex. Manually and Hitachi 726 automated analyzer. Clin. Chem. 32:1551-4 (1986)
MICROPROTEIN STANDARD 1 x 3 mL
Stabilized protein solution 100 mg/dL
Verified against NIST reference material.
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 15 - 250C.
LINEARITY
This reagent is linear up to 500 mg/dL with a sensitivity of 5mg/dL.
If the concentration is greater than linearity (500 mg/dL), dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Urine < 24 mg/dL
Urine 24 hour < 120 mg /24 hour
CSF < 40 mg/dL
PREPARATION AND STABILITY OF REAGENT
Reagents are ready to use.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
SAMPLE
Urine & CSF
Note: For haemolized or turbid samples it is suggested to carry out a sample blank:
add 10 µL of sample to 1 mL of DI water and read the absorbance at 600 nm against
DI water.
GENERAL SYSTEM PARAMETER
Mode of Reaction End point
Slope of reaction Increasing
Wavelength 600 nm
Temperature 370C
Blank Reagent
Standard concentration 100 mg/dL
Linearity 500 mg/dL
Incubation Time 5 minutes
Sample volume 10 µL
Reagent volume 1000 µL
Cuvette 1 cm light path

47
 50 Test
TIBC 11023001
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of Total Iron Binding Mode of Reaction End Point
Capacity in serum.
Slope of reaction Increasing
CLINICAL SIGNIFICANCE Wavelength 630 nm
Total iron-binding capacity (TIBC) is the measure of the ability of serum
Temperature RT
proteins, principally transferrin, to bind iron. It is the maximum
concentration Standard concentration 200 µg/dL
of iron that the serum proteins can bind. Linearity 500 µg/dL
Increase in TIBC is found in Iron deficiency anemias and pregnancy. Blank Reagent Blank
Decrease in TIBC is found in hypoproteinemia, hemolytic / pernicious /
sickle cell anemias, inflammatory diseases and cirrhosis. Incubation Time 10 min
Sample volume 40 µL
PRINCIPLE
TIBC is determined by addition of sufficient Fe(III) to saturate iron Reagent volume 1000 µL
binding sites on apotransferrin. The Fe 3+ is removed by adsorption with Cuvette 1 cm light path
basic magnesium carbonate powder. After centrifugation bound iron
remaining in supernatant is measured. LABORATORY PROCEDURE
The difference between TIBC values and serum iron gives the 1. Serum Saturation procedure
concentration of unsaturated transferrin(UIBC). Serum 500 µL
Reagent A 10 µL
REAGENT COMPOSITION
Mix and leave at room temperature for 10 minutes; then add one aliquote of reagent
TIBC REAGENT A 1 x 5 mL B and shake; leave at room temperature for 15 minutes shaking at regular intervals (4
Iron saturating solution 25 mg/dL times with vortex for 10-15 seconds). Centrifuge until you get a clear supernatant.
After centrifugation seperate the clear supernatent from the precipitate, and determine
TIBC REAGENT B 50 x 50 mg the TIBC using iron reagent.
Magnesium Carbonate (Powder) 2. TIBC Determination
STORAGE AND STABILITY Blank Standard Sample
The sealed reagents are stable up to the expiry date stated on the label, Iron Reagent 1000 µL 1000 µL 1000 µL
when stored at 15-25 0C and protected from light. Distilled water 40 µL - -
LINEARITY Iron Standard - 40 µL -
This reagent is linear up to 500µg/dL. TIBC supernatent - - 40 µL
If the concentration is greater than linearity (500µg/dL), dilute the Mix and incubate for 10 minutes at room temperature. Read the absorbance(A) of
sample with normal saline and repeat the assay. Multiply the result standard and sample against blank at 630 nm. The colour is stable for 1 hour if
with dilution factor. protected from light
EXPECTED VALUES CALCULATION
It is recommended that each laboratory establish its own reference Absorbance of Sample
values. TIBC µg/dL = --------------------------------- x 200
The following value may be used as guide line. Absorbance of Standard
TIBC : 250 - 400 µg/dL
UIBC : 160 - 360 µg/dL UIBC = TIBC - Iron level
PREPARATION OF WORKING REAGENT
Reagent is ready to use.
PRECAUTION
To avoid contamination, use clean laboratory wares. It is recommended
to use disposable tubes. Use clean, dry disposable pipette tips for
dispensing. Close reagent bottles immediately after use. Avoid direct
exposure of reagent to light.
Note: Use acid washed (50% HNO 3) glass wares and tips.
SAMPLE
Serum (free from haemolysis)

ADL/V.01/APR 2012

48
 4 x 50 mL
TOTAL PROTEIN 11013003
INTENDED USE LABORATORY PROCEDURE
This reagent is intended for in vitro quantitative determination of Total Protein in Blank Standard Sample
serum or plasma. Reagent 1000 µL 1000 µL 1000 µL
- Direct Biuret Method Standard - 20 µL -
- Linearity up to 15 gm/dL Sample - - 20 µL
CLINICAL SIGNIFICANCE Mix and incubate for 10 minutes at 370C. Measure the absorbance of standard and
sample against reagent blank.
Proteins form the major portion of dissolved substances in the plasma. They form
the basic structural components of the body. They constitute the enzymes present CALCULATION
in our body & also act as secondary source of energy. The other functions include Absorbacne of sample
distribution of water, buffering, transport of various components, defense & Total Protein Conc. (g/dL) = ------------------------------ x 6
coagulation of blood in our body.
Absorbance of standard
Increased levels are found in dehydration & myeloma.
Decreased levels are found in liver disorders, Nephrotic syndrome, malnutrition & BIBLIOGRAPHY
protein due to haemorrhage. Gomall, A.; J.Biol. Chem, 177 C (1949) 751
PRINCIPLE
Colorimetric determination of total protein based on the principle of the Biuret reaction
(copper salt in an alkaline medium). Protein in plasma or serum sample forms a blue
colored complex when treated with cupric ions in alkaline solution. The intensity of
the blue color is proportional to the protein concentration.
REAGENT COMPOSITION
TOTAL PROTEIN REAGENT 4 x 50 mL
Potassium iodide 6 mmol/L
Potassium sodium tartarate 21 mmol/L
Copper Sulphate 6 mmol/L
Sodium hydroxide 58 mmol/L
TOTAL PROTEIN STANDARD 1 x 3 mL
Total protein standard Concentration 6 gm/dL
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at room temperature and standard at 2- 80C.
LINEARITY
The procedure is linear up to 15 gm/dL. If the concentration is greater than linearity
(15 gm/dL), dilute the sample with normal saline and repeat the assay. Multiply the
result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum : 6.2 – 8.0 gm/dL
PREPARATION AND STABILITY OF REAGENT
Reagent is ready to use.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
SAMPLE
Serum / plasma (free of haemolysis)
GENERAL SYSTEM PARAMETER
Mode of Reaction End point
Slope of reaction Increasing
Wavelength 546 nm
Temperature 370C
Standard Concentration 6 g/dL
Linearity 15 g/dL
Blank Reagent
Incubation time 10 min
Sample volume 20 µL
Reagent volume 1000 µL
Cuvette 1 cm light path

49
 2 x 10 mL
ZINC 11024001
INTENDED USE GENERAL SYSTEM PARAMETER
This reagent is intended for in vitro quantitative determination of Zinc in serum. Mode of Reaction End Point
CLINICAL SIGNIFICANCE Slope of reaction Increasing
Zinc is needed for the body’s defensive (immune) system to properly work. It plays Wavelength 578 nm
a role in cell division, cell growth, wound healing, and the break down of
carbohydrates . Z inc is also needed for the senses of smell and taste. Z inc Temperature 30 oC
supplements in large amounts may cause diarrohea, abdominal cramps, and Standard concentration 200 µg/dL
vomiting. Decreased levels are found in cirrhosis, lung carcinomas, sickle cell Linearity 1000 µg/dL
anemia, acute myocardial infarction, renal failure, corticosteroid and oral
contraceptive therapy . Blank Reagent Blank
Although zinc is an essential requirement for good health, excess zinc can be harmful Incubation Time 5 min
PRINCIPLE Sample volume 50 µL
Zinc in an alkaline medium reacts with Nitro-PAPS to form a coloured complex. Reagent volume 1000 µL
Intensity of the colour is directly proportional to the amount of Zinc present in the Cuvette 1 cm light path
sample.
LABORATORY PROCEDURE
REAGENT COMPOSITION Blank Standard Sample
ZINC REAGENT 1 2 x 8 mL WorkingReagent 1000 µL 1000 µL 1000 µL
Borate buffer(pH 8.2) 0.3 M Distilled water 50 µL - -
Salicilaldoxime 12.5 mM Standard - 50 µL -
Dimethylglioxime 1.25 mM Sample - - 50 µL
Mix and incubate for 5 minutes at 30 oC. Read the absorbance(A) of standard and
ZINC REAGENT 2 2 x 2 mL sample against blank at 578 nm. The colour is stable for 30 minutes.
NITRO-PAPS 0.4mM
Preservatives CALCULATION
Absorbance of Sample
ZINC STANDARD 1 x 4mL Zinc µg/dL = ------------------------------- x 200
Z inc Standard (Concentration) 200 µg/dL Absorbance of Standard
STORAGE AND STABILITY INTERFERENCE
The sealed reagents are stable up to the expiry date stated on the label, when stored Bilirubin uo to 20 mg/dL does not interfere.
at 2-80C and protected from light.
BIBLIOGRAPHY
LINEARITY
1. Pasquinelli, F.; Diagnostica e Tecniche di Laboratorio, (pag.:1103-1104) Rossini
This reagent is linear up to 1000 µg/dL. Editrice.(1984)
If the concentration is greater than linearity (1000 µg/dL), dilute the sample with 2. Testsuo Makino; Chimica Clinica Acta 197, 209-220(1991)
normal saline and repeat the assay. Multiply the result with dilution factor. 3. Maringonia, A., Illuzi, R, ATB 1991 Abstract.
REFERENCE VALUES
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum or Plasma : 70 - 115 µg/dL
Urine (24 hours) : 100 - 1000 µg/dL
PREPARATION OF WORKING REAGENT
Mix 4 parts of Reagent 1 with 1 part of Reagent 2.
PRECAUTION
To avoid contamination, use clean laboratory Wares. It is recommended to use
disposable tubes. Use clean, dry disposable pipette tips for dispensing. Close reagent
and standard bottles immediately after use. Avoid direct exposure of reagent to
light.
SAMPLE
Serum or Plasma (free haemolysis). Use heparin as anticoagulant.
Urine (24 hours)

ADL/V.01/APR 2012

50
 1 x 30/1 x 3/1 mL
ALPHA 1-ACID GLYCOPROTEIN WITH CALIBRATOR 11822002
INTENDED USE CALIBRATION
This reagent is intended for in vitro quantitative determination of Alpha1- Acid Preparation of calibration curve:
Glycoprotein in human serum Dilute the high concentrated calibrator 1/10 using saline and use this diluted calibrator
- Turbidimetric Immunoassay for the preparation of calibration curve.
- Linear up to 300 mg/dL Prepare the following calibrator dilution using normal saline as diluent. Multiply the
- Ready to use reagents concentration of the AGP calibrator by the corresponding factor stated in the table
- Multipoint calibration below to obtain the AGP concentration of each dilution.
Dilution 1 2 3 4 5 6
CLINICAL SIGNIFICANCE 1/10dil.cal.(µL) - 10 10 25 50 100
Alpha-1-acid Glycoprotein is an acute-phase serum protein that is produced by the Saline(µL) 100 150 70 75 50 -
liver in response to inflammation and infection. AGP is useful in monitoring tumor
recurrence. Levels are also helpful in differentiating acute phase responses (elevated Dil.factor 0 0.0625 0.125 0.25 0.5 1.0
levels) from estrogen effects (normal or depressed levels). In addition, it is an LABORATORY PROCEDURE FOR FULLY AUTO
excellent protein in assessing in vivo hemolysis. Blank Calibrator Sample/control
PRINCIPLE AGP R 1 300 µL 300 µL 300 µL
The reagents containing polyclonal goat antihuman AGP when mixed with the serum Dil.Calibrator - 2.5 µL -
sample containing AGP cause changes in absorbance, due to the development of
turbidity, which is directly proportional to the concentration of Alpha 1- Acid Dil.Sample/control - - 2.5 µL
Glycoprotein in the sample. Mix and incubate for 5 minutes at 37°C. Measure the absorbance (A1) at 340 nm.
REAGENT COMPOSITION AGP R 2 30 µL 30 µL 30 µL
ALPHA 1- ACID GLYCOPROTEIN (AGP) R1 1 x 30 mL Mix well and incubate for 5 minutes at 37°C. Measure the absorbance (A2) at 340
Phosphate buffered saline (pH 7.43) nm.
Polyethylene glycol (60 g/L)
Alternative Procedure for Semi autoanalyzer:
Sodium azide (0.95 g/L)
Blank Calibrator Sample/control
ALPHA 1- ACID GLYCOPROTEIN (AGP) R2 1 x 3 mL
Phosphate buffered saline (pH 7.43) AGP R 1 500 µL 500 µL 500 µL
Polyclonal goat anti-human Alpha 1- Acid Glycoprotein Dil.Calibrator - 5 µL -
(variable) Dil.Sample/control - - 5 µL
Sodium azide (0.95 g/L) Mix and incubate for 5 minutes at 37°C.
Calibrator 1 x 1 mL AGP R 2 50 µL 50 µL 50 µL
Calibrator concentration is mentioned on vial label
Mix well and incubate for 5 minutes at 37°C. Measure the absorbance against the
STORAGE AND STABILITY reagent blank at 340 nm.
The reagents are stable until expiry date when kept at 2-80C.
CALCULATION
NORMAL RANGE Multi point calibration
It is recommended that each laboratory establish its own reference values. Calculate the Abs, plot a standard curve & read the concentration of controls &
The following values may be used as guide line. samples.
Male : 50 - 130 mg/dL PERFORMANCE CHARACTERISTICS:
Female : 40 - 120 mg/dL Measuring Range:- 4- 300 mg/dL.
PRECAUTION If the concentration is greater than linearity (300 mg/dL), dilute the diluted(1/10)
To avoid contamination, use clean laboratory wares. Use clean, dry disposable pipette sample with normal saline and repeat the assay. Multiply the result with dilution factor.
tips for dispensing. Close reagent bottles immediately after use. Avoid direct exposure Prozone Effect:- >600 mg/dL
of reagent to light. Precision in CV%:-
SAMPLE Low Medium High
Use fresh serum. Dilute sample/control to 1/10 with saline. Intra - Run 4.66 1.14 2.45
GENERAL SYSTEM PARAMETERS FOR SEMI AUTO FOR FULLY AUTO Inter - Run 2.55
Mode of reaction End point End point Accuracy in mg/dL:-
Slope of reaction Increasing Increasing control Assigned value Measured value
Wavelength 340 nm 340 nm level 1 44.3(35.5-53.2) 45.98
Temperature 37 oC 37 oC level 2 69.3(55.5-83.2) 72.3
Calibrator concentration As on vial label x Dilution factor level 3 89 (71.2 - 107) 94.1
Linearity 300 mg/dL 300 mg/dL INTERFERENCE
Blank Reagent Blank Reagent Blank No interference for
Incubation time 5 min +5 min 5 min +5 min Hemoglobin upto 1000 mg/dL
Sample volume 5 µL 2.5 µL Na- citrate upto 1000 mg/dL
Reagent 1 volume 500 µL 300 µL Heparin upto 50 mg/dL
Reagent 2 volume 50 µL 30 µL Bilirubin upto 20 mg/dL
Cuvette 1 cm light path 1 cm light path Triglyceride upto 2500 mg/dL
BIBLIOGRAPHY
1. Schmid,K. in FW Putman (Ed), The plasma protein,Vol 1, Second edition, Academic
Press, New York 2975, ppt 184-228
2. Johnson, A.M. et al., J. Clin. Invest., 48 (1969)2293
3. Dati,F. et al.,Lab.Med. 13 (1989)87

ADL/V.02/February 2013

51
 1 x 30/1 x 5/1 mL
Apo A1 WITH CALIBRATOR 11811001
INTENDED USE CALIBRATION
This reagent is intended for in vitro quantitative determination of Apolipoprotein A1 Preparation of calibration curve:
in serum or plasma. Reconstitute the Apo A1 calibrator with 1 mL of distilled water. The reconstituted
-Turbidimetric Immunoassay calibrator is stable for 7 days at 2-8oC.
-Linear up to 300 mg/dL Dilute the high concentrated calibrator 1/10 using normal saline and use this diluted
-Ready to use reagents calibrator for the preparation of calibration curve.
-Multipoint calibration Prepare the following calibrator dilution using NaCl as diluent. Multiply the
concentration of the Apo A1 calibrator by the corresponding factors stated in the table
CLINICAL SIGNIFICANCE below to obtain the Apo A1 concentration of each dilution.
Apo A1 is the main protein component of HDL. Apo A1 activates lecithin cholesterol Dilution 1 2 3 4 5 6
acyltransferase which catalyses the esterification of cholesterol this can then be 1/10dilCali. (µL) - 10 10 20 50 100
transported to the liver, metabolized and excreted. People with atherosclerotic vascular
changes frequently exhibit decreased levels of Apo A1. Even if the concentrations of Saline (µL) 100 150 70 60 50 -
apolipoprotein B are normal, a decreased ApoA1 level may be a risk factor for Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
atherosclerosis. Decreased levels of ApoA1 also occur in dyslipoproteinemias, acute LABORATORY PROCEDURE FOR FULLY AUTO
hepatic cirrhosis and insulin treated patients.
Blank Calibrator Sample/control
PRINCIPLE Apo A1 R 1 240 µL 240 µL 240 µL
Anti-human Apo A1 antisera when mixed with human serum containing Apo A1, react
to cause an absorbance change , which is measured by immunoturbidometric Dil.Calibrator - 4 µL -
principle. The change in the absorbance can be interpolated in a calibration curve Dil.Sample/control - - 4 µL
prepared with different known concentrations of calibrator. Mix and incubate for 5 minutes at 37°C. Read the absorbance (A1) at 340 nm.
REAGENT COMPOSITION Apo A1 R 2 40 µL 40 µL 40 µL
Apo A1 R1 1 x 30 mL Mix and incubate for 5 minutes at 37°C. Measure the absorbance (A2) at 340 nm.
Phosphate buffered saline (pH 7.43)
Polyethylene glycol 60 g/L ALTERNATIVE PROCEDURE FOR SEMI AUTO ANALYZER:
Detergent 0.1% Calibrator Sample/control
Sodium azide 0.95 g/L Apo A1 R 1 450 µL 450 µL
Apo A1 R2 1 x 5 mL Dil.Calibrator 5 µL -
Phosphate buffered saline (pH 7.43) Dil.Sample/control - 5 µL
Polyclonal goat anti-human Apo-A1(Variable)
Apo A1 R 2 75 µL 75 µL
Sodium azide 0.95g/L
Calibrator 1 x 1 mL Mix well, measure absorbance A1 immediately after addition of ApoA1 R2 and take
absorbance (A2) exactly after 300 sec at 340 nm.
Calibrator concentration is mentioned on vial label
STORAGE AND STABILITY CALCULATION
The sealed reagents are stable up to expiry date stated on the label, when stored at 2 Multipoint calibration
- 8oC. Calculate Abs plot standard curve and read the concentration of controls and
samples.
REFERENCE RANGE
It is recommended that , each laboratory establish its own PERFORMANCE CHARACTERISTICS:
reference values. The following values may be used as guidelines. Measuring Range:- 4 - 300 mg/dL.
Men : 107 - 177 mg/dL If the concentration is greater than 300mg/dl dilute the diluted(1/10) sample with
normal saline and repeat the assay. Multiply the result with dilution factor.
Women : 107 - 205 mg/dL
Prozone Effect:- >5500mg/dL
PRECAUTION Precision in CV%:-
To avoid contamination, use clean laboratory wares; use clean dry disposable pipette Low Medium High
tips for dispensing, close reagent bottle immediately after use . Avoid direct exposure
of reagent to light. Intra - Run 3.05 1.12 1.48
Inter - Run 1.63
SAMPLE
Use fresh serum. Dilute sample/control to 1 /10 with saline Accuracy in mg/dL
GENERAL SYSTEM PARAMETERS FOR SEMI AUTO FOR FULLY AUTO control Assigned value Measured value
Mode of reaction Fixed Time End point evel 1 126(100-152) 137.62
Slope of reaction Increasing Increasing level 2 88(70-106) 88.6
Wavelength 340 nm 340 nm INTERFERENCE
Temperature 37o C 37o C No interference upto
Calibrator concentration As on vial label x Dilution factor Hemoglobin 1000mg/dL
Linearity 300 mg/dL 300 mg/dL Triglyceride 2500 mg/dL
Blank DI Water Reagent Blank Bilirubin 20mg /dL
Incubation time 5 min +5 min 5 min +5 min BIBLIOGRAPHY
Delay 5 sec - 1. Tillett. W. S.et al: Serological reactions in pneumonia with a non-protein samatic
Delta 300 sec - fraction of pneumococcus. J.Exp.Med..52,561(1930)
Sample volume 5 µL 4 µL 2. Ziegenhagen G, Drahovshy D. klinishe Bedeutung des Creaktiven protein. Med klin
Reagent 1 volume 450 µL 240 µL 1983;78:45-50.
Reagent 2 volume 75 µL 40 µL 3. Rifal. N.Tracy.R.P.Ridker, P.M.; Clinical efficacy of an Automated High
sensitivity C-Reactive protein Assay. Clin. chem.45:12.
Cuvette 1 cm light path 1 cm light path

52
 1 x 30/1 x 5/1 mL
Apo B WITH CALIBRATOR 11812001
INTENDED USE CALIBRATION
This reagent is intended for in vitro quantitative determination of Apo B in serum. Preparation of calibration curve:
-Turbidometric Immuno assay Reconstitute the Apo B calibrator with 1 mL of distilled water. The reconstituted
calibrator is stable for 7 days at 2-8oC. Dilute the high concentrated calibrator 1/10
-High Linearity of 330 mg/dL using saline and use this diluted calibrator for the preparation of calibration curve.
-Ready to use reagents Prepare the following calibrator dilution using NaCl as diluent. Multiply the
-Multi point calibration concentration of the Apo B calibrator by the corresponding factor stated in the table
CLINICAL SIGNIFICANCE below to obtain the Apo B concentration of each dilution.
Apo B is the main protein component of LDL. It is necessary for the reaction with LDL Dilution 1 2 3 4 5 6
receptors in the liver and on cell walls and thus involved in transporting cholesterol, 1/10Dil.cal.(µL) - 10 10 20 50 100
from the liver to the vessel cells. Saline (µL) 100 150 70 60 50 -
Elevated levels of Apo-B are frequently found in atherosclerotic vascular changes and Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
are a risk factor for atherosclerosis.
LABORATORY PROCEDURE FOR FULLY AUTO
PRINCIPLE Blank Calibrator Sample/control
The reagents containing polyclonal goat antihuman Apo-B antibodies when mixed with Apo B R 1 240 µL 240 µL 240 µL
the serum sample containing Apo-B cause changes in absorbance due to the
development of turbidity, which is directly proportional to the concentration of Dil.Calibrator - 10 µL -
Apo-B in the sample. Dil.Sample/control - - 10 µL
REAGENT COMPOSITION Mix and incubate for 5 minutes at 37°C. Read the absorbance(A1) at 340 nm.
Apo B R1 1 x 30 mL Apo B R 2 40 µL 40 µL 40 µL
Phosphate buffered saline (pH 7.43) Mix and incubate for 5 minutes at 37°C. Measure the absorbance(A2)at 340 nm.
Polyethyleneglycol 60 g/L
Detergent 0.1% ALTERNATIVE PROCEDURE FOR SEMI AUTO ANALYZER
Sodium azide. 0.95 g/L Calibrator Sample/control
Apo B R2 1 x 5 mL Apo B R 1 450 µL 450 µL
Polyclonal goat anti-human Apo-B(Variable) Dil.Calibrator 15 µL -
Sodium azide 0.95 g/L Dil.Sample/control - 15 µL
Phosphate buffer pH 7.43 Apo B R 2 75 µL 75 µL
Calibrator 1 x 1 mL
Mix well, measure absorbance immediately and after addition of Apo B R2 (A1)and
Calibrator concentration is mentioned on vial label take absorbance exactly after 300 sec(A2) at 340 nm.
STORAGE AND STABILITY
CALCULATION
The sealed reagents are stable upto the expiry date mentioned on the label when stored
at 2-8oC. Multipoint calibration
Calculate abs, plot a standard curve & read the concentration of controls and
REFERENCE RANGE samples.
It is recommended that, each laboratory establishes its own reference values. The
following values may be used as reference. PERFORMANCE CHARACTERISTICS:
Men : 60 - 138 mg/dL Measuring Range:- 8 - 330 mg/dL.
Women : 52 - 129 mg/dL If the concentration is greater than 300 mg/dL , dilute thediluted(1/10) sample with
normal saline and repeat the assay .Multiply the result with dilution factor.
PRECAUTION Prozone Effect:- >5000mg/dL
To avoid contamination, use clean laboratory wares, such as pipette tips and test Precision in CV%:-
tubes. Close reagent bottle immediately after use. Avoid direct exposure of reagent Low Medium High
to light.
Intra - Run 5.24 1.16 0.91
SAMPLE
Inter - Run 1.02
Use fresh serum . Dilute sample/ control to 1/10 in saline
GENERAL SYSTEM PARAMETERS Semi Auto Fully Auto Accuracy in mg/dL
Mode of reaction Fixed Time End point control Assigned value Measured value
Slope of reaction Increasing Increasing Biorad level 1 84.4(67.8-101) 83.16
Wavelength 340 nm 340 nm Biorad level 2 47.2(37.6-56.8) 47.39
Temperature o
37 C 37o C IINTERFERENCE
Calibrator concentration As on vial label x Dilution factor No interference for
Linearity 330 mg/dL 330 mg/dL Hemoglobin upto 1000 mg/dL
Blank DI Water Reagent Blank Triglyceride upto 2500 mg/dL
Incubation time - 5 min +5 min Bilirubin upto 20 mg /dL
Delay 5 sec - BIBLIOGRAPHY
Delta 300 sec - 1. Tillett. W.S. et al: Serological reactions in Pneumonia a non-protein somatic fraction
Sample volume 15 µL 10 µL of pneumococcus. J. Exp.Med..52,561(1930)
Reagent 1 volume 450 µL 240 µL 2. Ziegenhagen G, Drahovshy D. klinishe Bedeutung des.Creaktiven protein. Med klin
Reagent 2 volume 75 µL 40 µL 1983;78:45-50.
3. Rifal. N.Tracy.R.P.Ridker, P.M.clinical efficacy of an
Cuvette 1 cm light path 1 cm light path Automated High sensitivity C-Reactive protein Assay. Clin. chem. 45:12.

53
 1X45 mL/1X5 mL/1 mL
ASO TURBILATEX WITH CALIBRATOR 11801001
INTENDED USE LABORATORY PROCEDURE
This reagent is intended for in vitro diagnostic quantitative determination of anti- Calibrator Sample/control
Streptolysin O (ASO) in serum. ASO reagent 1 900 µL 900 µL
Linear up to 800 IU/mL Calibrator 10 µL -
Single point calibration
Sample/control - 10 µL
CLINICAL SIGNIFICANCE ASO reagent 2 100 µL 100 µL
Streptolysin O is a toxic immunogenic exoenzyme produced by beta-hemolytic
streptococcus group A, C and G. Measuring the antibodies ASO is useful for the Mix and read the absorbance immediately (A1) and after 2 minutes (A2) of sample
diagnosis of rheumatoid fever, acute glomerulonephritis and streptococcal infections. addition at 546 nm.
Rheumatic fever is an inflammatory disease affecting connective tissue from several CALCULATION
parts of human body such as skin, heart joints etc., and acute glomerulonephritis is
a renal infection that affects mainly renal glomerulus. (A2-A1) sample x calibrator concentration
ASO con. in IU/mL = -------------------------------------------------------------
PRINCIPLE (A2-A1) calibrator
The reagent ASO-Turbilatex agglutination assay is a quantitative turbidimetric assay for
measurement of ASO in human serum or plasma. PERFORMANCE CHARACTERISTICS
Latex particles coated with streptolysin O are agglutinated when mixed with samples Measuring range: 20-800 IU/mL
containing ASO. The agglutination causes an absorbance change, dependent upon the The reagent is linear up to 800 IU/mL.
ASO contents of the patient sample that can be quantified by comparison from a If the concentration is greater than linearity, dilute the sample with normal saline and
calibrator of known ASO concentration. repeat the assay. Multiply the result with dilution factor.
REAGENT COMPOSITION 1. Detection limit: Values less than 20 IU/mL gives non reproducible results
ASO TURBILATEX R1 1 x 45 mL 2. Prozone effect: No prozone effect was detected up to 2000 IU/mL.
Diluent INTERFERENCES
Tris buffer 20 mmol/L No interference
Sodium azide 0.95 g/L Rheumatoid factors : up to 300 IU/mL
ASO TURBILATEX R2 1 x 5mL Bilirubin : up to 20mg/dL
ASO-Latex: Lipemia : up to 10g/L.
Suspension of latex particles coated with BIBLIOGRAPHY
streptolysin O, (pH 10.0) 1. Haffejee, Quarterly Journal of Medicine 1992, New Series 84; 305: 641-658
Sodium azide 0.95 g/L 2. Alouf et al Biochemie. 1973; 56-61.
ASO CALIBRATOR 1 x 1 mL
Calibrator concentration is stated on the vial label.
PRECAUTIONS: Components from human origin have been tested and found to be
negative for the presence of HbsAg, and HCV and of antibody to HIV (1/2). However
handle cautiously as potentially infectious.
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2-8oC.
NORMAL RANGE
It is recommended that each laboratory establish its own reference value. The following
value may be used as guideline.
Serum
up to 200 IU/mL(adults)
up to 100 IU/mL (children below 5 years)
PREPARATION AND STABILITY OF REAGENT
ASO calibrator:Reconstitute the calibrator with 1mL distilled water. Reconstituted
calibrator is stable for 30 days at 2-8oC.
PRECAUTION
To avoid contamination, use clean laboratory wares. Avoid direct exposure of working
reagent to light.
SAMPLE
Fresh serum. (Do not use hemolyzed or lipemic serum)
GENERAL SYSTEM PARAMETERS
Mode of reaction Fixed time
Slope of reaction Increasing
Wavelength 546 nm (530-550nm)
Temperature 370C
Calibrator concentration As on vial label
Linearity 800 IU/mL
Blank DI water
Delay time 5 sec
Interval 120 sec
Sample volume 10 µL
Reagent 1 volume 900 µL
Reagent 2 volume 100 µL
Cuvette 1 cm path length

54
 1 x 24 /1 x 8 /1 mL, 2 x 24 /2 x 8 /2 mL
ASO LEIT WITH CALIBRATOR 11807004, 11807005
LABORATORY PROCEDURE FOR FULLY AUTO
INTENDED USE Blank Calibrator Sample/control
This reagent is intended for in vitro quantitative determination of Anti Streptolysin –
O (ASO). ASO R1 210 µL 210 µL 210 µL
-Latex enhanced immunoturbidimetry Calibrator - 3 µL -
-Ready to use reagents Sample/control - - 3 µL
-No sample dilution required Incubate for 5 minutes at 370C.
-Linear up to 800 IU/mL ASO R2 70 µL 70 µL 70 µL
CLINICAL SIGNIFICANCE Mix and read the absorbance immediately (A1), and after 4 minutes (A2) at 570/800
ß - hemolytic streptococcus bacteria especially group A, C and G, produce an exotoxin nm.
known as Streptolysin-O. People infected with this bacterium produce an antibody
known as Anti Streptolysin-O (ASO). Measuring the levels of ASO is effective for ALTERNATIVE PROCEDURE FOR SEMI AUTO
diagnosing, judging the progress of medical treatment and assessing the recovery from Calibrator Sample/control
diseases like rheumatic fever, acute glomerulonephritis and tonsillitis. ASO R1 450 µL 450 µL
PRINCIPLE Calibrator 5 µL -
When an antigen-antibody reaction occurs between ASO in the sample and Sample/control - 5 µL
streptolysin-O which has been sensitized to latex particles, agglutination occurs. This
agglutination results in change of absorbance and is proportional to the quantity of ASO R2 150 µL 150 µL
ASO in the sample. The concentration can be determined by comparison with a Mix and read the absorbance immediately (A1), and after 4 minutes (A2) at 578 nm.
calibrator of known ASO concentration
CALCULATION
REAGENT COMPOSITION (A2-A1) sample
ASO R 1 1 x 24 mL, 2 x 24 mL ASO Conc. in IU/mL = ------------------------- x Calibrator Conc.
Glycine buffer solution (A2-A1) calibrator
ASO R2 1 x 8 mL, 2 x 8 mL
ASO Latex suspension particles coated with Streptolysin - O PERFORMANCE CHARACTERISTICS:
CALIBRATOR 1 x 1 mL, 1 x 2 mL Measuring Range:- 20 – 800 IU/mL.
ASO calibrator concentration as on vial label If the concentration is greater than 800 IU/mL, dilute the sample with normal saline
and repeat the assay. Multiply the result with dilution factor.
STORAGE AND STABILITY Prozone Effect:- > 5600 IU/mL
The sealed reagents are stable up to the expiry date stated on the label, when stored Precision in CV%:-
at 2- 80C. Medium High
NORMAL RANGE Intra - Run 5.0 3.0
It is recommended that each laboratory should establish its own reference values. Inter - Run 8 5
The following values may be used as guide line. Accuracy in IU/mL
Serum control Assigned value Measured value
Adults : 200 IU/mL level 1 121(96.9-145) 105.7
children < 5 years : 100 IU/mL level 2 198(158-237) 187.4
PRECAUTION level 3 284(227-341) 247
To avoid contamination use clean laboratory wares. Use clean dry disposable pipette INTERFERENCES
tips for dispensing. Close reagent bottles immediately after use. Avoid direct exposure Do not interfere for
of reagent to light. Hemoglobin up to 500 mg/dL
SAMPLE Bilirubin up to 20 mg/dL
Fresh serum / plasma Intrafat up to 5000 mg/dL
BIBLIOGRAPHY
GENERAL SYSTEM PARAMETER SEMI AUTO FULLY AUTO 1. Galuin, J.P. et al.: Particle enhanced photometric immune assay system, Clin. Lab
Mode of Reaction Fixed time End point Assays (pap .Annu.clin.Lab.Assays Conf.)
Slope of reaction Increasing Increasing 2. Singer J.M. et al. The latex fixation test Application to the serologic diagnosis or
rheumatoid arthritis, Amer J.Med 21, 888(1956)
Wavelength 578 nm 570/800 nm
Temperature 370C 37 0C
Calibrator Concentration As on vial label As on vial label
Linearity 800 IU/mL 800 IU/mL
Blank DI water Reagent blank
Delay time 5 sec -
Interval 240 sec -
Sample volume 5 µL 3 µL
Reagent 1 volume 450 µL 210 µL
Reagent 2 volume 150 µL 70 µL
Cuvette 1 cm light path 1 cm light path

55
 1 x 30/1 x 5/1 mL
C3 WITH CALIBRATOR 11819001
INTENDED USE CALIBRATION
This reagent is intended for in vitro quantitative determination of complement C3 in PREPARATION OF CALIBRATION CURVE
human serum.
Dilute the calibrator to 1/10 using normal saline and use this diluted calibrator for
-Turbidimetric Immunoassay the preparation of the calibration curve. Prepare the following calibrator dilution using
-Linear up to 400 mg/dL NaCl as diluent. Multiply the concentration of the C3 calibrator by the corresponding
-Ready to use reagents factors stated in the table below to obtain the C3 concentration of each dilution.
-Multipoint calibration Dilution 1 2 3 4 5 6
CLINICAL SIGNIFICANCE 1/10 Cali. (µL) - 10 10 25 50 100
complement C3 is the central point of the classic and alternative complement pathway. Saline (µL) 100 150 70 75 50 -
Complement testing help to diagnose the cause of recurrent microbial infections, Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
angioedema, or inflammation. It may be used to help diagnose and to monitor the LABORATORY PROCEDURE FOR FULLY AUTO ANALYZER
activity of acute or chronic autoimmune diseases such as Systemic Lupus Blank Calibrator Sample/Control
Erythematosus (SLE).
Decreased levels of C3 are significant in autoimmune disease, immune infections C3 R 1 200 µL 200 µL 200 µL
with pyrogenic bacteria, bacteremia, neonatal respiratory distress syndrome and Dil. Calibrator - 3 µL -
congenital deficiencies.C3 behaves as an acute phase protein hence increased levels Dil.Sample/control - - 3 µL
may found in acute inflammatory reactions.
Mix and incubate for 5 minutes at 37°C. Measure the absorbance (A1) at 340 nm.
PRINCIPLE
C3 R 2 30 µL 30 µL 30µL
The reagents containing polyclonal goat antihuman C3 when mixed with the serum
sample containing C3 cause changes in absorbance, due to the development of Mix and incubate for 5 minutes at 37°C. Measure the absorbance (A2) at 340 nm.
turbidity, which is directly proportional to the concentration of C3 in the sample.
ALTERNATIVE PROCEDURE FOR SEMI AUTO ANALYZER:
REAGENT COMPOSITION Blank calibrator sample /control
C3 R1 1 x 30 mL C3 R1 450 µL 450 µL 450 µL
Phosphate buffered saline (pH 7.43)
Dil calib - 5µL -
Polyethylene glycol (40 g/L)
Sodium azide (0.95 g/L) Dil sample/control - - 5µL
C3 R2 1 x 5 mL Mix and incubate for 5 minutes at 37oC.
Phosphate buffered saline (pH 7.43) C3 R2 75 µL 75 µL 75 µL
Polyclonal goat anti-human C3C (variable) Mix and incubate for 5 minutes at 37oC. Measure the absorbance against reagent
Sodium azide (0.95 g/L) blank at 340 nm.
Calibrator 1 x 1 mL
Calibrator concentration is mentioned on vial label CALCULATION
Multipoint calibration.
STORAGE AND STABILITY Calculate the Abs. Plot a standard curve and read concentration of controls and
The reagents are stable until expiry date when kept at 2-80 C samples.
NORMAL RANGE PERFORMANCE CHARACTERISTICS:
It is recommended that each laboratory establish its own reference values. Measuring Range:- 20 –400 mg/dL.
The following values may be used as guide line. If the concentration is greater than linearity(400 mg/dL), dilute the diluted
Serum 75-135 mg/dL (1/10)sample with normal saline and repeat the assay. Multiply the result with dilution
factor.
PRECAUTION Prozone Effect:- >1000mg/dL
To avoid contamination, use clean laboratory wares. Use clean, dry disposable pipette Precision in CV%:-
tips for dispensing. Close reagent bottles immediately after use. Avoid direct exposure
of reagent to light. Low Medium High
SAMPLE Intra - Run 2.82 3.43 3.28
Use fresh serum. Dilute sample/control to 1/10 with saline. If the test cannot be carried Inter - Run 3.71 2.56
out on the same day, the serum may be stored at 2-80 C for 48 hours. Accuracy in mg/dl:-
control Assigned value Measured value
GENERAL SYSTEM PARAMETERS FOR SEMI AUTO FOR FULLY AUTO level 1 80.2(64.1-96.2) 78.57
Mode of reaction End point End point level 2 166(133-199) 173.2
Slope of reaction Increasing Increasing level 3 254(203-305) 249.7
Wavelength 340 nm 340 nm INTERFERENCE
Temperature 37 oC 37 oC No interference for
Calibrator concentration As on vial label x Dilution factor Hemoglobin upto1000 mg/dL
Linearity 400 mg/dL 400 mg/dL Na-citrate upto1000 mg/dL
Blank Reagent Blank Reagent Blank Heparin upto50 mg/dL
Incubation time 5 min +5 min 5 min +5 min Bilirubin upto20 mg/dL
Sample volume 5 µL 3 µL Triglyceride upto2500 mg/dL
Reagent 1 volume 450 µL 200 µL
BIBLIOGRAPHY
Reagent 2 volume 75 µL 30 µL
1. Dati, F. et al., Lab. Med.13, 87 (1989)
Cuvette 1 cm light path 1 cm light path 2. Muller-Eberhard, H.H., Ann. Rev.Biochem.44, 697(1975)
calibration curve spline 3. Lachmann, P.J., Hobart, M.J. and Ashton, W.P. (1973)

ADL/V.02/February 2013

56
 1 x 30/1 x 5/1 mL
C4 WITH CALIBRATOR 11820001
INTENDED USE CALIBRATION
This reagent is intended for in vitro quantitative determination of complement C4 in PREPARATION OF CALIBRATION CURVE
human serum.
Dilute the high concentration calibrator to 1/10 with normal saline and use this
-Turbidimetric Immunoassay diluted calibrator for the preparation of calibration curve. Prepare the following
-Linear up to 80 mg/dL calibrator dilution using NaCl as diluent. Multiply the concentration of the C4
-Ready to use reagents calibrator by the corresponding factors stated in the table below to obtain the C4
-Multipoint calibration concentration of each dilution.
CLINICAL SIGNIFICANCE
Dilution 1 2 3 4 5 6
C4 is a constituent of C3 convertase & C5 convertase.
1/10 dil.Cali. (µL) - 10 10 25 50 100
Decreased levels are found in hereditary angioneurotic odema, immune complex
disease and congenital deficiencies. Saline (µL) 100 150 70 75 50 -
Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
PRINCIPLE
The reagents containing polyclonal goat antihuman C4 when mixed with the serum LABORATORY PROCEDURE FOR FULLY AUTO ANALYZER
sample containing C4 cause changes in absorbance, due to the development of Blank Calibrator Sample/control
turbidity, which is directly proportional to the concentration of C4 in the sample. C4 R 1 200 µL 200 µL 200 µL
REAGENT COMPOSITION Dil. Calibrator - 3 µL -
C4 R1 1 x 30 mL Dil.Sample/control - - 3 µL
Phosphate buffered saline (pH7.43) Mix and incubate for 5 minutes at 37°C. Read the absorbance (A1) at 340 nm.
Polyethylene glycol (40 g/L)
C4 R 2 30 µL 30 µL 30 µL
Sodium azide (0.95 g/L) Mix and incubate for 5 minutes at 37°C. Measure the absorbance (A2) at 340 nm.
C4 R2 1 x 5 mL
Phosphate buffered saline (pH 7.43) ALTERNATIVE PROCEDURE FOR SEMI AUTO ANALYZER:
Polyclonal goat anti-human C4C (variable) Blank Calibrator Sample/control
Sodium azide (0.95 g/L) C4 R 1 450 µL 450 µL 450 µL
CALIBRATOR 1 x 1 mL Dil. Calibrator - 5 µL -
Calibrator concentration is mentioned on vial label Dil.Sample/control - - 5 µL
STORAGE AND STABILITY Mix and incubate for 5 minutes at 37°C.
The reagents are stable until expiry date when kept at 2-80 C. C4 R 2 75 µL 75 µL 75 µL
NORMAL RANGE Mix and incubate for 5 minutes at 37°C. Measure the absorbance against reagent
It is recommended that each laboratory establish its own reference values. blank at 340 nm.
The following values may be used as guide line.
CALCULATION
Serum : 9 - 36 mg/dL
Multipoint calibration
PRECAUTION Calculate the Abs, plot a standard curve and read the concentration of controls
To avoid contamination, use clean laboratory wares. Use clean, dry disposable pipette and samples.
tips for dispensing. Close reagent bottles immediately after use. Avoid direct exposure
of reagent to light. PERFORMANCE CHARACTERISTICS:
Measuring Range:- 2 –80 mg/dL.
SAMPLE If the concentration is greater than linearity (80 mg/dL), dilute thediluted(1/10) sample
Use fresh serum. Dilute the sample/control to 1/10 with saline. If the test cannot be with normal saline and repeat the assay. Multiply the result with dilution factor.
carried out on the same day, the serum may be stored at 2-80 C for 48 hours. Prozone Effect:- >1000mg/dL
Precision in CV%:-
GENERAL SYSTEM PARAMETERS FOR SEMI AUTO FOR FULLY AUTO Low Medium High
Mode of reaction End point End point Intra - Run 4.54 2.18 3.96
Slope of reaction Increasing Increasing Inter - Run 4.17 3.08
Wavelength 340 nm 340 nm Accuracy in mg/dL
Temperature 37 oC 37 oC control Assigned value Measured value
Calibrator concentration As on vial label x Dilution factor level 1 12.7(10.1-15.2) 12.11
Linearity 80 mg/dL 80 mg/dL level 2 28.3(22.7-34.0) 27.4
Blank Reagent Blank Reagent Blank level 3 41.8(33.5-50.2) 39.9
Incubation time 5 min +5 min 5 min +5 min INTERFERENCE
Sample volume 5 µL 3µL No interference for
Reagent 1 volume 450 µL 200 µL Hemoglobin upto1000 mg/dL
Reagent 2 volume 75 µL 30 µL Na-citrate upto1000 mg/dL
Cuvette 1 cm light path 1 cm light path Heparin upto 50 mg/dL
calibration curve spline Turbidity upto 5%
Bilirubin upto 20 mg/dL
Triglyceride upto2500 mg/dL
BIBLIOGRAPHY
1. Dati, F. et al., Lab. Med.13, 87 (1989)
2. Muller-Eberhard, H.H., Ann. Rev.Biochem.44, 697(1975)

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57
 1 x 30/1 x5 /1 mL
CERULOPLASMIN WITH CALIBRATOR 11813001
INTENDED USE CALIBRATION
This reagent is intended for in vitro quantitative determination of Ceruloplasmin in Preparation of calibration curve:
serum. Prepare the following calibrator dilution using normal saline as diluent. Multiply the
-Turbidimetric Immuno assay concentration of the Ceruloplasmin calibrator by the corresponding factors stated in
-Linear up to 100 mg/dL the table below to obtain the Ceruloplasmin concentration of each dilution.
-No sample dilution needed Dilution 1 2 3 4 5 6
-Ready to use reagents Cali. (µL) - 10 10 20 50 100
-Multipoint calibration Saline (µL) 100 150 70 60 50 -
Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
CLINICAL SIGNIFICANCE
Ceruloplasmin is a copper oxidase enzyme, important in regulating the ionic state of LABORATORY PROCEDURE FOR FULLY AUTO
iron and other metallic ions. Levels are decreased in hepatolenticular degeneration or Blank calib Sample/control
Wilson's disease and Menke's kinky hair syndrome. Levels are elevated by the acute Ceruloplasmin R1 300 µL 300 µL 300 µL
phase response and particularly by estrogens.
Dil.Calibrator - 4 µL -
PRINCIPLE
Sample/control - - 4 µL
The reagents containing polyclonal goat antihuman ceruloplasmin when mixed with
the serum sample containing ceruloplasmin cause changes in absorbance due to Mix and incubate for 5 minutes at 37°C. Read the absorbance(A 1) at 340 nm.
the development of turbidity, which is directly proportional to the concentration Ceruloplasmin R2 50 µL 50 µL 50 µL
of Ceruloplasmin in the sample. Mix and incubate for 5 minutes at 37°C. Measure the absorbance (A2) at 340 nm.
REAGENT COMPOSITION ALTERNATIVE PROCEDURE FOR SEMI AUTO ANALYZER
Ceruloplasmin - R1 1 x 30 mL Calibrator Sample/control
Phosphate buffered saline (pH 7.43)
Ceruloplasmin R 1 450 µL 450 µL
Polyethylene glycol 40 g/L
Sodium azide 0.95 g/L Dil.calibrator 5 µL -
Ceruloplasmin - R2 1 x 5 mL Sample/control - 5 µL
Phosphate buffered saline (pH 7.43) Ceruloplasmin R 2 75 µL 75 µL
Polyclonal goat anti- human Ceruloplasmin Mix well, measure absorbance (A1)immediately after addition of Ceruloplasmin R2 and
Sodium azide 0.95 g/L take absorbance exactly after 300 sec (A2) at 340 nm.
Calibrator 1 x 1 mL CALCULATION
Calibrator concentration is mentioned on vial label Multipoint calibration
STORAGE AND STABILITY Calculate the Abs, plot a standard curve & read the concentration of controls &
The sealed reagents are stable upto the expiry date mentioned on the label when stored samples.
at 2-8oC. Do not freeze. PERFORMANCE CHARACTERISTICS:
REFERENCE RANGE Measuring Range:- 4 - 100 mg/dL.
It is recommended that, each laboratory should establishes its own reference values. If the concentration is greater than 100 mg/dL , dilute the diluted(1/10)sample with
The following value may be used as a reference. normal saline and repeat the assay. Multiply the result with dilution factor.
serum : 22 - 61 mg/dL Prozone Effect:- > 400 mg/dL
PRECAUTION Precision in CV%:-
To avoid contamination, use clean laboratory wares, such as pipette tips and test Low Medium High
tubes. Close reagent bottle immediately after use. Avoid direct exposure of reagent Intra - Run 6.31 2.07 2.20
to light. Inter - Run 3.91
SAMPLE Accuracy in mg/dL
Fresh serum. control Assigned value Measured value
GENERAL SYSTEM PARAMETERS Semi Auto Fully Auto level 1 18.7(14.9-22.4) 20.98
Mode of reaction Fixed Time End point level 2 35.8(28.7-43.0) 38.3
Slope of reaction Increasing Increasing level 3 50.2(40.1-60.2) 48.57
Wavelength 340 nm 340 nm Interference:-
Temperature 37o C 37o C No interference for
Calibrator concentration As on vial label x Dilution factor Hemoglobin upto 1000 mg/dL
Linearity 100 mg/dl 100 mg/dl Na - citrate upto 1000 mg/dL
Blank DI Water Reagent Blank Heparin upto 50 mg/dL
Incubation time 5 min 5 min + 5min Bilirubin upto 20 mg/dL
Delay 5 sec - Triglycerides upto 2500 mg/dL
Delta 300 sec -
BIBLIOGRAPHY
Sample volume 5 µL 4 µL
Poulik , M.D and Kleiss M.L in “The plasma proteins”, F.W. Putman, (ed.) Vol. 2
Reagent 1 volume 450 µL 300 µL Second edition, Academic press, New York, PP 52-108
Reagent 2 volume 75 µL 50 µL
Cuvette 1 cm light path 1 cm light path

ADL/V.02/February 2013

58
 1X45 mL/1X5mL/1X1mL
CRP TURBILATEX WITH CALIBRATOR 11802001
INTENDED USE LABORATORY PROCEDURE
This reagent is intended for in vitro diagnostic quantitative determination of C-reactive Calibrator Sample /control
protein (CRP) in serum. CRP R1 900 µL 900 µL
Linear up to 150 mg/L Calibrator 5µL ---
Single point calibration
Sample --- 5 µL
CLINICAL SIGNIFICANCE CRP R2 100 µL 100 µL
CRP (C – reactive Protein) is a cytokine - induced, acute phase protein that increases
in concentration as a result of inflammation. CRP levels in the body has been used as Mix and read the absorbance immediately (A1) and after 2 minutes (A2) of sample
a marker or indicator of infections and inflammation. The assay of CRP is more addition.
sensitive than the erythrocyte sedimentation rate (ESR) and leukocyte count. The CRP CALCULATION
levels rise and return to reference ranges more rapidly after the disease has subsided.
(A2-A1) sample x calibrator concentration
PRINCIPLE CRP Conc. in mg/L = -------------------------------------------------------
This is a quantitative turbidimetric immuno assay for the measurement of CRP in (A2-A1) calibrator
human serum. CRP in the samples binds to specific anti-CRP antibodies, which have
been adsorbed to latex particles and agglutinates. The agglutination is proportional PERFORMANCE CHARACTERISTICS
to the quantity of CRP in the sample. The actual concentration is then determined by 1. Linearity : The reagent is linear up to 150 mg/L. If the concentration is greater than
interpolation from a calibration curve prepared from calibrators of known linearity, dilute the sample with normal saline and repeat the assay. Multiply the
concentrations. result with dilution factor.
REAGENT COMPOSITION 2. Detection limit: Values less than 2mg/L gives non reproducible results
3. Prozone effect: No prozone effect was detected up to 800 mg/L.
CRP TURBILATEX R1 1x45 mL
Diluent INTERFERENCES
Tris buffer 20 mmol/L No interference
Sodium azide 0.95 g/L Rheumatoid factors : up to 300 IU/mL
CRP TURBILATEX R2 1x5 mL Bilirubin : up to 20 mg/dL
CRP-Latex: Lipemia : up to 10 g/L.
Suspension of latex particles coated with BIBLIOGRAPHY
anti human CRP 1. Haffejee, Quarterly Journal of Medicine 1992, New Series 84; 305: 641-658
Sodium azide 0.95 g/L 2. Alouf et al Biochemie. 1973; 56-61.
CRP CALIBRATOR 1x1 mL
Calibrator concentration is stated on the vial label.
PRECAUTIONS: Components from human origin have been tested and found to be
negative for the presence of HbsAg, and HCV and of antibody to HIV (1/2). However
handle cautiously as potentially infectious.
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2-8oC.
NORMAL RANGE
It is recommended that each laboratory establish its own reference value. The following
value may be used as guideline.
Serum : up to 6 mg/L
PREPARATION AND STABILITY OF REAGENT
CRP calibrator: Reconstitute the calibrator with 1mL of distilled water.Reconstituted
calibrator is stable for 30 days at 2-80C.
PRECAUTION
To avoid contamination, use clean laboratory wares. Avoid direct exposure of working
reagent to light.
SAMPLE
Fresh serum. (Do not use hemolyzed or lipemic serum)
GENERAL SYSTEM PARAMETERS
Mode of reaction Fixed time
Slope of reaction Increasing
Wavelength 546 nm (530-550nm)
Temperature 37 oC
Calibrator concentration As on vial label
Linearity 150 mg/L
Blank DI water
Delay time 5 sec
Interval 120 sec
Sample volume 5 µL
Reagent 1 volume 900 µL
Reagent 2 volume 100 µL
Cuvette 1 cm path length

59
 1 x 24 / 1 x 8 / 2 mL, 2 x 24 / 2 x 8 / 2 mL
CRP LEIT WITH CALIBRATOR 11808004, 11808005
INTENDED USE CALIBRATION
This reagent is intended for in vitro quantitative determination of C-reactive protein Preparation of calibration curve:
in human serum or plasma by immunoturbidimetry. Prepare the following calibrator dilutions using normal saline as diluent. Multiply the
-Latex enhanced immunoturbidimetry concentration of the CRP calibrator by the corresponding factor stated in the table
-Linear up to 200 mg/L below to obtain the CRP concentration of each dilution.
-Ready to use reagents Dilution 1 2 3 4 5 6
-No sample dilution needed Cali. (µL) - 10 10 20 50 100
Saline (µL) 100 150 70 60 50 -
CLINICAL SIGNIFICANCE
Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
CRP (C – Reactive Protein) is a cytokine - induced, acute phase protein that increases
in concentration as a result of inflammation. CRP levels in the body has been used as LABORATORY PROCEDURE FOR FULLY AUTO ANALYZER
a marker or indicator of infections and inflammation. The assay of CRP is more Blank calibrator Sample/Control
sensitive than the erythrocyte sedimentation rate (ESR) and leukocyte count. The CRP
levels rise and return to reference ranges more rapidly after the disease has subsided. CRP R 1 210 µL 210 µL 210 µL
Dil. Calibrator - 3 µL -
PRINCIPLE
This is a latex enhanced turbidimetric immuno assay. CRP in the samples binds to Sample/control - - 3 µL
specific anti-CRP antibodies, which have been adsorbed to latex particles and Mix and incubate for 5 minutes at 37°C.
agglutinates. The agglutination is proportional to the quantity of CRP in the sample. CRP R 2 70 µL 70 µL 70 µL
The actual concentration is then determined by interpolation from a calibration curve
prepared from calibrators of known concentrations. Mix and measure the absorbance immediately (A1) and after 2 minutes (A2) at 570/
800nm.
REAGENT COMPOSITION
CRP R1 1 x 24 mL, 2 x 24 mL ALTERNATIVE PROCEDURE FOR SEMI AUTO ANALYZER:
Glycine buffer calibrator Sample/Control
CRP R2 1 x 8 mL, 2 x 8 mL CRP R 1 450 µL 450 µL
Latex suspension coated with anti-CRP antibodies. (rabbit polyclonal antibody) Dil. Calibrator 5 µL -
CALIBRATOR 1 x 2 mL, 1 x 2 mL Sample/control - 5 µL
CRP calibrator concentration as on vial label CRP R 2 150 µL 150 µL
STORAGE AND STABILITY Mix and measure the absorbance immediately (A1) and after 2 minutes (A2) at 578nm.
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2-8oC. CALCULATION
Multi point calibration
NORMAL RANGE Calculate the Abs, plot a standard curve & read the concentration of controls &
It is recommended that each laboratory should establish its own reference values. samples.
The following value may be used as a guide line.
Serum up to 6 mg/L PERFORMANCE CHARACTERISTICS:
Measuring Range:- 1 –200 mg/L.
PRECAUTION If the concentration is greater than 200 mg/L, dilute the sample with normal saline
To avoid contamination, use clean laboratory wares. Avoid direct exposure of reagent and repeat the assay. Multiply the result with dilution factor.
to light. Prozone Effect:- >1000 mg/L
The reagent should be used according to this pack insert. If used otherwise, Precision in CV%:-
appropriate performance is not guaranteed.
Low Medium High
SAMPLE Intra - Run 7.0 5.0 3.0
Fresh serum (Do not use hemolized or lipemic serum)
Inter - Run 10 8 5
GENERAL SYSTEM PARAMETER SEMI AUTO FULLY AUTO Accuracy in mg/L
Mode of Reaction Fixed Time End point control Assigned value Measured value
Slope of reaction Increasing Increasing level 1 5.85(4.68-7.02) 5.05
Wavelength 578 nm 570/ 800nm level 2 27.3(21.9-32.8) 26.8
Temperature 370C 37 0C level 3 51.9(41.5-62.2) 49.6
No.of calib. 6 6 INTERFERENCE
Calibrator concentration As on vial label x Dilution factor No interference for
Linearity 200 mg/L 200 mg/L Hemoglobin 500 mg/dL
Blank DI Water Reagent blank Intrafat 500 mg/dL
Delay 5 sec -- Bilirubin 30 mg/dL
Interval 120 sec -- RF 500 IU/mL
Sample volume 5 µL 3 µL BIBLIOGRAPHY
Reagent 1 volume 450 µL 210 µL 1. Tillett.W.S..et al: Serological reactions in pneumonia with a non protein somatic
Reagent 2 volume 150 µL 70 µL fraction of pneumococcus.J.Exp.Med..52,561(1930).
Cuvette 1cm light path 1cm light path 2. Zeigenhagen G,Drahovshy D.Klinishe Bedeutung des C-reaktiven protein.Med klin
1983;78:45-50.
3. Rifal.N.Tracy.R.P.Ridker,P.M.Clinical efficacy of an Automated High sensitivity C-
Reactive protein Assay: Clin chem. 45-12.

60
 1x18 / 1x9 / 2 mL
CRP ULTRA WITH CALIBRATOR 11808006
INTENDED USE Calibrator Concentration As on vial label X Dilution Factor
This reagent is intended for in vitro quantitative determination of C-reactive protein Linearity 10mg/L 10 mg/L
(CRP) in serum. Blank Reagent Blank DI water
-Latex Enhanced Immuno Turbidimetric assay Delay time - 5 sec
-Sensitivity of 0.13 mg/L Interval - 120 sec
-Linearity up to 10 mg/L Sample volume 5 µL 10 µL
-Ready to use reagent Reagent 1 volume 200 µL 400 µL
Reagent 2 volume 100 µL 200 µL
CLINICAL SIGNIFICANCE
CRP is an acute phase protein produced by liver. It’s level will rise in response to CALIBRATION
inflammations and infections. PREPARATION OF CALIBRATION CURVE
Inflammation of arteries is a risk factor for cardiovascular disease. It is linked to an Prepare the following calibrator dilution using normal saline as diluent. Multiply the
increased risk of heart disease, heart attack, stroke and peripheral arterial disease. CRP concentration of the CRP ultra calibrator by the corresponding factors stated in the
ultra/HS CRP is the strongest predictor of cardiac risk. The value more than 10 mg/L table below to obtain the CRP ultra concentration of each dilution.
cannot be considered for cardiac risk factors.
Dilution 1 2 3 4 5 6
Routinely available CRP methods are to determine infections or chronic inflammatory
disease where CRP concentration is above 10 mg/L. These methods are with limited Calib.(µL) - 10 10 20 50 100
sensitivity hence it cannot precisely measure CRP concentrations below 10 mg/L. Saline(µL) 100 150 70 60 50 -
Studies have shown that measuring CRP with improved methodology of high sensitive Dil. Factor 0 0.0625 0.125 0.25 0.5 1.0
assay can identify the risk level of CVD in apparently healthy people. Relatively high
levels of hs CRP in healthy individuals are predictive of the future risk of heart disease
even when cholesterol levels are within the acceptable range. LABORATORY PROCEDURE FOR SEMI AUTO ANALYSER
Calibrator Sample/control
PRINCIPLE
CRP ultra R 1 400 µL 400 µL
This is a latex-enhanced turbidimetric invitro immuno assay. CRP in the sample binds
to specific anti-CRP antibodies, which had been adsorbed to latex particles and |Dil. Calibrator 10 µL -
agglutinates. The agglutination is detected as an absorbance change. The magnitude Sample/control - 10 µL
of the change is proportional to the concentration of CRP in the sample. The actual
concentration is then detected by interpolation from a calibration curve prepared from CRP ultra R 2 200 µL 200 µL
calibrators of known concentration. Mix and read absorbance immediately(A1), and after 2 minutes(A2)of the sample
addition at 578 nm.
REAGENT COMPOSITION
CRP Ultra R1 1 x 18 mL LABORATORY PROCEDURE FOR FULLY AUTO ANALYSER
Glycine buffer Blank Calibrator Sample/control
CRP Ultra R2 1 x 9 mL CRP ultra R 1 200 µL 200 µL 200 µL
Latex suspension coated with anti-CRP antibodies. (Rabbit polyclonal antibody) Dil. Calibrator - 5 µL -
CALIBRATOR 1 x 2 mL Sample/control - - 5 µL
Ready to use CRP calibrator, the concentration is as on the vial label
Mix and incubate for 5 minutes at 370C
PRECAUTIONS: Components from human origin have been tested and found to be
negative for the presence of HBsAg, and HCV and of antibody to HIV (1/2). However, CRP ultra R 2 100 µL 100 µL 100 µL
handle cautiously as potentially infectious. Mix and read absorbance immediately(A1), and after 2 minutes(A2)of the R2 addition
STORAGE AND STABILITY at 570/800 nm.
The sealed reagents are stable up to the expiry date stated on the label, when stored CALCULATION
at 2-80C. Stability in the instrument is at least 4 weeks if contamination is avoided. Multipoint calibration
Do not freeze. Calculate the Abs , plot a standard curve & read the concentration of controls &
REFERENCE RANGE samples.
It is recommended that each laboratory should establish its own reference values. PERFORMANCE CHARACTERISTICS:
The following value may be used as guide line. Measuring Range:- 0.13 – 10 mg/L.
Less than 1 mg/L = Low risk for CVD Prozone Effect:- >1000 mg/L
1.0-2.9 mg/L = Intermediate Risk for CVD Precision in CV%:-
Greater than 3 mg/L = High Risk for CVD Low Medium High
PREPARATION AND STABILITY OF REAGENT Intra - Run 7 5 3
The Reagent1 & Reagent 2 are ready to use. Inter - Run 10 8 5
Calibrator :Ready to use Interference:-
PRECAUTION INTERFERING SUBSTANCES
To avoid contamination, use clean laboratory wares. Use clean, dry disposable pipette Test will not be affected by:
tips for dispensing. Close reagent bottles immediately after use.
Hemoglobin up to 500 mg/dL
Avoid direct exposure of reagent to light. Do not blow into the reagent bottles.
Conjugated Bilirubin up to 30 mg/dL
SAMPLE
Intra Fat up to 500 mg/dL
Fresh serum (free of haemolysis)
Rheumatoid Factor up to 500 IU/mL
GENERAL SYSTEM PARAMETER FULLY AUTO SEMI AUTO
Mode of Reaction End point Fixed time BIBLIOGRAPHY
Slope of reaction Increasing Increasing 1. Claus, D. R; Osmand, A.P.; Gewurz, H. Radioimmunoassay of human C-reactive
Wavelength 570/800nm 578 nm protein and levels in normal sera. J .Lab. Clin Med 1976;87: 120-128
2. Wasunna, A, Whitelaw, A. Gallimore, R. Hawkins, P.N. Pepys, M. B. C-reactive protein
Temperature 370C 37 0C and bacterial infection in preterm infants. Eur J Pediatr 1990; 149: 424-427
No.of standards 6 6

61
 1 x 25/1 x 5/2 mL
CYSTATIN-C WITH CALIBRATOR 11810001
INTENDED USE Dilution of calibrator for calibration curve:
This reagent is intended for in vitro quantitative determination of Cystatin C in human Calibration Curve (range between 0-10 mg/L). Prepare the following calibrator dilution
serum. using normal saline as diluent. Multiply the concentration of the Cystatin C calibrator
-Latex enhanced Immunoturbidimetry by the corresponding factor stated in the table below to obtain the Cystatin C
-Ready to use reagents concentration of each dilution.
-No sample dilution required Dilution 1 2 3 4 5 6
-Linear up to 10 mg/L Cali. (µL) - 10 10 20 50 100
Saline (µL) 200 190 70 60 50 -
CLINICAL SIGNIFICANCE Dil. factor 0 0.05 0.125 0.25 0.5 1.0
Cystatin C is a low molecular weight (13 Da) cytoplasmic protein, functioning as an
inhibitor of various cystein protease in the blood stream. Cystatin C has a stable LABORATORY PROCEDURE FOR FULLY AUTO ANALYZER
production rate and is removed from the blood circulation by glomerular filtration. Blank Calibrator Sample/control
In healthy individuals Cystatin C is completely reaborsorbed and degraded in the Cystatin R1 200 µL 200 µL 200 µL
tubules but in subject with renal disorders its level in blood may be raised as high as
2 to 5 times the normal values. Cystatin C is superior to serum creatinine as a marker Dil.Calibrator - 3 µL -
of glomerular filtration Rate. Sample/control - - 3 µL
PRINCIPLE Mix and incubate for 5 minutes at 37oC.
Cystatin C in the test sample binds to the specific polyclonal rabbit anti-Cystatin C Cystatin R2 40 µL 40 µL 40 µL
antibody, which has been adsorbed to latex particle and agglutinates. The agglutination
is detected as absorbance change at 546 nm. The magnitude of change is proportional Mix and read the absorbance immediately (A1), and after 5 minutes (A2) at 546/
to the quantity of Cystatin C in the sample and its concentration is determined by 800nm.
interpolation from a calibration curve prepared from calibrators of known ALTERNATIVE PROCEDURE FOR SEMI AUTO ANALYZER
concentration.
Calibrator Sample/control
REAGENT COMPOSITION Cystatin R1 500 µL 500 µL
Cystatin C R1 1 x 25 mL
Dil.Calibrator 5 µL -
Tris buffer 1.2% (100 mM)
pH 8.5+0.3 Sample/control - 5 µL
Cystatin C R2 1 x 5 mL Cystatin R2 100 µL 100 µL
Polystyrene latex particle coated with polyclonal anti Cystatin C antibody (rabbit) Mix and read the absorbance immediately (A1), and after 5 minutes (A2) at 546nm.
CALIBRATOR 1 x 2 mL
CALCULATION
Cystatin C calibrator concentration as mentioned on the vial label.
Multipoint calibration
STORAGE AND STABILITY Calculate the abs, plot a standard curve & read the concentration of controls &
The sealed reagents are stable up to the expiry date stated on the label, when stored samples.
at 2- 80C.
PERFORMANCE CHARACTERISTICS:
NORMAL RANGE Measuring Range:- 0.1 - 10 mg/L.
It is recommended that each laboratory establish its own reference values. If the concentration is greater than 10 mg/L, dilute the sample with normal saline and
The following value may be used as guide line. repeat the assay .Multiply the result with dilution factor.
Individuals up to 50 years : 0.55 – 1.15 mg/L Prozone Effect:- >60 mg/L
Individuals above 50 years : 0.63 – 1.44 mg/L Precision :
PREPARATION OF REAGENT MEAN INTRA RUN INTER RUN n
Reagent 1 and Reagent 2 are ready to use. VALUE CV(%) CV(%)
Cystatin –C calibrator: Ready to use Liquid stable. Low human serum pool 0.77 2.16 2.54 20
Unopened vials are stable till expiration date mentioned on the vials. Opened vials are High human serum pool 5.94 0.67 1.45 20
stable for 4 weeks when stored at 2-80C. Medium human serum pool 1.45 1.58 1.95 20
PRECAUTIONS: Medium human serum pool 2.72 1.22 1.37 20
To avoid contamination, use clean laboratory wares, such as pipette tips and test Low human serum pool 0.46 3.96 4.77 20
tubes. Close reagent bottle immediately after use. Avoid direct exposure of reagent to High human serum pool 3.82 1.81 3.05 20
light.
Accuracy in mg/L
SAMPLE control Assigned value Measured value
Required sample material is human serum or EDTA/ Heparinized plasma. It is level 1 0.484(0.387-0.581) 0.438
recommended to analyze the sample as fresh as possible. level 2 0.572(0.457-0.686) 0.530
level 3 0.649(0.519-0.779) 0.614
GENERAL SYSTEM PARAMETER SEMI AUTO FULLY AUTO
Mode of Reaction Fixed time End point IINTERFERENCE
Slope of reaction Increasing Increasing No interference upto
Wavelength 546 nm 546 nm/ 800nm Hemoglobin 500 mg/dL
Temperature 370C 370C Intrafat 1400 mg/dL
No of calib 6 6 Bilirubin 25 mg/dL
Calibrator Conc. As on vial label x Dilution factors BIBLIOGRAPHY
Linearity 10 mg/L 10 mg/L 1. Cystatin-C as a marker of GFR - history, indications and future research; Clin.
Blank DI Water Reagent blank Biochem.38:1, 2005
Delay Time 5 sec -- 2. Serum Cystatin -C is superior to serum creatinine as a marker of kidney function:
Interval 300 sec -- a meta analysis. Am. J. Kidney Desease. 40, 221, 2002.
Sample volume 5 µL 3 µL
Reagent 1 volume 500 µL 200 µL
Reagent 2 volume 100 µL 40 µL
Cuvette 1 cm light path 1 cm light path

62
 1 x 30/1 x 10/1 mL
FERRITIN WITH CALIBRATOR 11814002
INTENDED USE LABORATORY PROCEDURE
The reagent is intended for in vitro quantitative determination of Ferritin in serum Blank calibrator Sample/control
-Latex Enhanced Immunoturbidimetry Ferritin R 1 210 µL 210 µL 210 µL
-High Linearity of 1000 ng/mL Dil. Calibrator - 3 µL -
-No sample dilution
Sample/control - - 3 µL
-Ready to use reagents
-Multipoint calibration Ferritin R 2 70 µL 70 µL 70 µL
Mix and read absorbance (A1) immediately and after 2 minutes (A2) at 570 nm and
CLINICAL SIGNIFICANCE 800 nm.
Ferritin is an iron-containing protein. It is mainly found in liver and spleen, where its
function is to store and release iron in the body. It is also found in small amounts in CALCULATION
human serum. The serum levels tend to increase due to hepatitis and malignant Multi point calibration
tumors. The measurement of ferritin is useful in diagnosis, treatment, assessment of Calculate the abs, plot a standard curve & read the concentration of controls &
disease progression and post operative prognosis of abnormal iron metabolism and samples.
iron deficiency anaemia.
PERFORMANCE CHARACTERISTICS:
PRINCIPLE Measuring Range:- 10 –1000 ng/mL.
Latex particles coated with anti-ferritin antibody are agglutinated when mixed with If the concentration is greater than 1000 ng/mL , dilute the sample with normal saline
samples containing Ferritin. The agglutination causes an absorbance change which and repeat the assay .Multiply the result with dilution factor.
depends on the Ferritin concentration in the sample, this can be interpolated using a
calibration curve prepared from calibrators of different concentrations. Prozone Effect:- >30000 ng/mL
Precision in CV%:-
REAGENT COMPOSITION Low High
Ferritin - R1 1 x 30 mL Intra - Run 10 7
Glycine buffer Inter - Run 12 10
Ferritin - R2 1 x 10 mL Accuracy in ng/mL
Suspension of latex particle bound to anti-ferritin antibodies control Assigned value Measured value|
Calibrator 1 x 1 ml level 1 31.2(24.9-37.4) 32.6
Calibrator concentration is mentioned on vial label level 2 193(154-231) 182.2
STORAGE AND STABILITY level 3 331(264-397) 303.67
The sealed reagents are stable upto the expiry date mentioned on the label when stored INTERFERENCE
at 2-8oC. No interference for
NORMAL RANGE Hemoglobin 500 mg/dL
It is recommended that, each laboratory should establish its own reference values. The Triglyceride 3000 mg/dL
following value may be used as a guide line. Bilirubin 30 mg/dL
Male : 30 - 220 ng/mL Rheumatoid factor 560 IU/mL
Females : 20 - 110 ng/mL BIBLIOGRAPHY
PRECAUTION 1. Cook, J.D., Lipschitz,D.A., Laughton, M.B.B., Miles, E.M. & Finch, C.A: Serum
To avoid contamination, use clean laboratory wares, use clean dry disposable pipette ferritin as a measure of iron stores in normal subjects. Am.J.clin.Nutr. 27: 680,
tips for dispensing, close reagent bottle immediately after use. Avoid direct exposure 1974.
of reagent to light. 2. Walters,G.O.,Miller, F.M & Wormwood, M.: Serum ferritin concentration on
and iron stores in normal subjects. J.Clin.Pathol. 26: 770-, 1973.
SAMPLE
Fresh Serum
GENERAL SYSTEM PARAMETER FULLY AUTO
Mode of reaction Rate
Slope of reaction Increasing
Wavelength 1 570 nm
Wavelength 2 800 nm
Temperature 37 oC
Calibrator concentration As on vial label x Dilution factor
Linearity 1000 ng/mL
Blank Reagent Blank
sample volume 3 µL
Reagent 1 volume 210 µL
Reagent 2 volume 70 µL
Cuvette 1 cm light path
CALIBRATION
Preparation of calibration curve:
Prepare the following calibrator dilutions using normal saline as diluent. Multiply the
concentration of the Ferritin calibrator by the corresponding factor stated in the table
below to obtain the Ferritin concentration of each dilution.
Dilution 1 2 3 4 5 6
Cali. (µL) - 10 10 20 50 100
Saline (µL) 100 150 70 60 50 -
Dil. factor 0 0.0625 0.125 0.25 0.5 1.0

63
 4 x 7.5/1 x 9.5/1 x 0.5/1x60mL/ 4 x 0.5 mL
HbA1c DIRECT WITH CALIBRATOR 11806001
INTENDED USE SAMPLE
This reagent is intended for in vitro quantitative determination of HbA1c in human Whole blood, collected with EDTA
blood. To determine HbA1c a heamolysate must be prepared for each sample
-Latex enhanced Immunoturbidimetry 1. Dispense 1mL hemolysis reagent into a tube.
-Ready to use liquid stable reagents 2. Add 20 µLof well-mixed whole blood and mix.
-Multipoint calibration 3. Allow to stand for 5 minutes or until complete lysis is evident.
Follow the same procedure with calibrators and controls.
-Direct result (% HbA1c) from analyzer
GENERAL SYSTEM PARAMETER FullyAuto
-No total Hb determination required
Mode of Reaction End point
CLINICAL SIGNIFICANCE Slope of reaction Increasing
HbA1c is a glycated form of haemoglobin formed by the attachment of glucose
residues in the blood to the hemoglobin molecules. In the diabetic population where Wavelength 600 nm
blood glucose levels are abnormally elevated the level of HbA1c also increases. The Temperature 370C
level of HbA1c is proportional to the level of glucose in the blood and has been widely Calibrator Concentration As on vial label
accepted as an indicator of the mean blood glucose concentration in the preceeding Linearity 16%
6-8 weeks. It is therefore a long-term indicator of diabetic control. For routine use
HbA1c levels should be monitored every 3-4 months. However in gestational diabetes Blank Reagent blank
and after a change in therapy it may be useful to measure HbA1c more frequently at Sample volume 6 µL
2-4 week intervals. Reagent 1 volume 210 µL
PRINCIPLE Reagent 2 volume 75 µL
This method utilizes the interaction of antigen and antibody to directly determine the Cuvette 1 cm light path
HbA1c in whole blood. Total heomoglobin and HbA1c have the same nonspecific LABORATORY PROCEDURE FOR FULLY AUTO
absorption rate to latex particle. When mouse antihuman HbA1c monoclonal
antibodies are added (R2), latex HbA1c – mouse antihuman HbA1c antibody complex Blank Calibrator Sample/control
is formed. Agglutination occurs when goat anti mouse IgG polyclonal antibody HbA1C R 1 210 µL 210 µL 210 µL
interacts with the monoclonal antibody. The amount of agglutination is proportional Hemolysate(calib) - 6 µL -
to the amount of HbA1c absorbed onto the surface of latex particles. The amount of
agglutination is measured as absorbance, which is used to calculate HbA1c % from Hemolysate(sample/control) - - 6 µL
a calibration curve. Mix & incubate for 5 min at 370C.
REAGENT COMPOSITION HbA1C R 2 75 µL 75 µL 75 µL
HbA1c R1 4 x 7.5 mL Mix and incubate for 5 min at 37oC and read absorbance(A) at 600 nm.
Latex
0.13%(w/v) CALCULATION
Glycine buffer 20 mmol/L Calibration curve
HbA1c R2A 1 x 9.5 mL Calculate the Abs of calibrators = Abs calibrator – Abs Blank. Plot the D Abs of each
Glycine buffer 80 mmol/L calibrator versus assigned concentration (HbA1c %) on a linear graph paper. HbA1c
results according to NGSP for the samples and controls are determined using the
HbA1c R2B 1 x 0.5 mL prepared calibration curve.
Mouse anti-human HbA1c 10 mmol/L Calculate
Monoclonal antibody Abs of sample ie abs Sample - abs Blank .
Goat anti-mouse IgG 0.05 mg/mL HbA1c % in the sample is calculated by interpolation of Abs of sample on the
(Polyclonal) calibration curve. For calculation of results according to IFCC, use IFCC calibrator
Stabilizers 0.08 mg/dL values (see calibrator insert), or use following equation.
HbA1c R3 1 x 60 mL NGSP = (0.915 x IFCC) + 2.15
Haemolysis Reagent Accuracy in %
HbA1c DIRECT CALIBRATOR 4 x 0.5 mL control Assigned value Measured value
HbA1c 4 level calibrator lyophilized. level 1 4.8 (3.8-5.9) 4.6
level 2 10.2(8.1-12.3) 10.1
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored INTERFERENCES
at 2- 80C, protected from light. No interference up to :
MEARUREMENT RANGE Ascorbic acid 50 mg/dL
4-16% (NGSP) Bilirubin 50 mg/dL
Triglycerides 2000 mg/dL
NORMAL RANGE Carbamylated Hb 7.5 mmol/L
It is recommended that each laboratory establish its own reference values. Acetylated Hb 5.0 mmol/L
The following value may be used as guide line. It has been reported that results may be inconsistent in patients who have the
According NGSP : following conditions: opiate addiction, lead poisoning, alcoholism, and ingestion of
<6% for non-diabetic large doses of aspirin. Elevated HbF levels may lead to under estimation of HbA1c.
< 7% for glycemic control of person with diabetes BIBLIOGRAPHY
PREPARATION AND STABILITY OF WORKING REAGENT 1. Nathan, D.M., Clin, Chem. 29, pp.466-469 (1983)
Reagent 1 & Reagent 3 are ready to use. 2. Engbeak, F., et al. Clin chem.35 pp. 93-97 (1989)
Reagent R2 is prepared by pouring the entire contents of the R2B vial into the R2A 3. American Diabetes Association : Clinical practice recommendations (position
vial. Mix gently. This working reagent is stable for 30 days at 2-80C. statement). Diabetes care 24 (suppl.1) S33-S55, (2001).
4. Tietz, N.W. Textbook of Clinical Chemistry, W.B. Saunders Company, p.794
Calibrator: Reconstitute with 0.5 mL distilled water and it will be stable up to -7795 (1999).
30 days at 2-80C. Do not freeze.
PRECAUTION
To avoid contamination, use clean laboratory wares. Use clean, dry disposable pipette
tips for dispensing. Close reagent and standard bottles immediately after use.
Avoid direct exposure of working reagent to light.

64
 1 x 30/1 x 10/1 mL
IgM WITH CALIBRATOR 11817001
INTENDED USE CALIBRATION
This reagent is intended for in vitro quantitative determination of IgM antibodies in Preparation of calibration curve:
serum. Prepare the following calibrator dilutions using normal saline as diluent. Multiply the
-Turbidimetric Immuno assay concentration of the IgM calibrator by the corresponding factor stated in the table
-Linear up to 500 mg/dL below to obtain the IgM concentration of each
-No sample dilution Dilution 1 2 3 4 5 6
-Ready to use reagents Cal. (µL) - 10 10 20 50 100
-Multipoint calibration Saline (µL) 100 150 70 60 50 -
Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
CLINICAL SIGNIFICANCE
IgM is important in early response to infections . The measurement of IgM is important LABORATORY PROCEDURE FOR FULLY AUTO ANALYZER
for typing immuno deficiencies and myelomas. IgM plays an important role in the Blank Calibrator Sample/control
humoral defense of the body. Serum levels may be increased in all kind of acute IgM R 1 180 µL 180 µL 180 µL
infections. Elevated levels in cord serum suggest clinical infection in the new born.
Dil. Calibrator - 3 µL -
PRINCIPLE
Sample/control - - 3 µL
Antibodies to IgM are combined with IgM in the patient’s serum, forming immune
complexes. The immune complexes cause an increase in light scattering which Mix and incubate for 5 minutes at 37°C. Read the absorbance (A1) at 340 nm & 700
correlate with the concentration of IgM in the serum. The light scattering is measured nm.
at 340 nm and 700 nm. IgM R 2 60 µL 60 µL 60 µL
REAGENT COMPOSITION Mix and incubate for 5 minutes at 37°C. Measure the absorbance(A 2) at 340 nm &
IgM R1 (Buffer solution) 1 x 30 mL 700 nm.
Tris(hydroxymethyl)aminomethane 100 mmol/L ALTERNATIVE PROCEDURE FOR SEMI AUTO ANALYZER:
IgM R2 (Antiserum solution) 1 x 10 mL Blank Calibrator Sample/control
Anti-human IgM antiserum IgM R 1 450 µL 450 µL 450 µL
Calibrator 1 x 1 mL
Dil. Calibrator - 5µ L -
Calibrator concentration is mentioned on vial label
Sample/control - - 5 µL
STORAGE AND STABILITY
Mix and incubate for 5 minutes at 37°C.
The sealed reagents are stable upto the expiry date mentioned on the label when stored
at 2-8 0C. Do not freeze. IgM R 2 150 µL 150 µL 150 µL
REFERENCE RANGE Mix well and incubate for 5 minutes at 37°C. Measure the absorbance(A ) against
reagent blank at 340 nm & 630 nm.
It is recommended that each laboratory establish its own reference values. The
following values may be used as reference. CALCULATION
Serum : 50 - 300 mg/dL Multipoint calibration
PRECAUTION Calculate the Abs, plot a standard curve & read the concentration of controls &
samples.
To avoid contamination, use clean laboratory wares. Avoid direct exposure of reagent
to light. PERFORMANCE CHARACTERISTICS:
The reagent should be used according to this pack insert. If used otherwise, Measuring Range:- 6 – 500 mg/dL
appropriate performance is not guaranteed. If the concentration is greater than 500 mg/dl , dilute the sample with normal saline
SAMPLE and repeat the assay. Multiply the result with dilution factor.
Fresh Serum. Prozone Effect:- >5000mg/dL
Precision in CV%:-
GENERAL SYSTEM PARAMETERS SEMI AUTO FULLY AUTO Low Medium High
Mode of reaction Endpoint Endpoint Intra - Run 1.43 1.59 0.64
Slope of reaction Increasing Increasing Inter - Run 3.17 3.65 2.49
Wavelength 340/630 nm 340/700 nm Accuracy mg/dL
Temperature 37 oC 37 oC control Assigned value Measured value
Calibrator concentration As on vial label x Dilution factor level 1 63.0(50.4-75.5) 64.1
Linearity 500 mg/dL 500 mg/dL level 2 140.0(112-168) 143.68
Blank Reagent Blank Reagent Blank level 3 206(165-247) 209.1
Incubation time(in minutes) 5min+ 5min 5min+ 5min INTERFERENCE
Sample volume 5 µL 3 µL No interference for
Reagent 1 volume 450 µL 180 µL Hemoglobin upto 1000mg/dL
Reagent 2 volume 150 µL 60 µL Triglyceride upto 2500 mg/dL
Cuvette 1 cm light path 1 cm light path Bilirubin upto 20mg /dL
Turbidity upto 5 %
BIBLIOGRAPHY
1. Otani, H. :Medical Technology,14, 965(1986)
2. Rinsho Kensa Guide 1992, 269-274(1992), BUNKODO CO. LTD.
3. Kanai’s manual of Clinical laboratory Medicine, 30th edition, 868- 873(1993),
KANEHARA & CO.,LTD.

ADL/V.02/February 2013

65
 1 x 15/1 x 15/1 mL
IgG WITH CALIBRATOR 11816001
INTENDED USE PROCEDURE
This reagent is intended for in vitro quantitative determination of IgG antibodies in Preparation of calibration curve:
serum. Prepare the following calibrator dilutions using normal saline as diluent. Multiply the
-Turbidimetric Immuno assay concentration of the IgG calibrator by the corresponding factor stated in the table
-High linearity of 2700 mg/dL below to obtain the IgG concentration of each dilution.
-Ready to use reagents Dilution 1 2 3 4 5 6
-Multipoint calibration Cal(µL) - 10 10 20 50 100
Saline (µL) 100 150 70 60 50 -
CLINICAL SIGNIFICANCE
Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
IgG is a predominant serum immunoglobulin . The measurement of IgG is important
for typing immunodeficiencies and myelomas. Increased levels are found in chronic LABORATORY PROCEDURE FOR FULLY AUTO
infections and chronic inflammation. IgG is the only immunoglobulin which crosses Blank Calibrator Sample/control
the placenta and is therefore of special importance in infants defense against
infection. IgG R 1 150 µL 150 µL 150 µL
Dil. Calibrator - 2 µL -
PRINCIPLE
Antibodies to IgG are combined with IgG in the patient’s serum, forming immune Sample/control - - 2 µL
complexes. The immune complexes cause an increase in light scattering which Mix and incubate for 5 minutes at 37°C. Read the absorbance (A1) at 340nm.
correlate with the concentration of IgG in the serum. The light scattering is IgG R 2 150 µL 150 µL 150 µL
measured by reading turbidity at 340 nm.
Mix and incubate for 5 minutes at 37°C. Measure the absorbance(A2) at 340nm.
REAGENT COMPOSITION
IgG R1 (Buffer solution) 1 x 15 mL ALTERNATIVE PROCEDURE FOR SEMI AUTO ANALYZER:
Tris(hydroxymethyl)aminomethane 100 mmol/L Blank Calibrator Sample/control
IgG R2 (Antiserum solution) 1 x 15 mL IgG R 1 250 µL 250 µL 250 µL
Anti-human IgG antiserum Dil. Calibrator - 5µL -
Calibrator 1 x 1 mL Sample/control - - 5 µL
Calibrator concentration is mentioned on vial label Mix and incubate for 5 minutes at 37°C.
STORAGE AND STABILITY IgG R 2 250 µL 250 µL 250 µL
The sealed reagents are stable upto the expiry date mentioned on the label when stored Mix and incubate for 5 minutes at 37°C. Measure the absorbance (A) at 340 nm.
at 2-8 0C.
CALCULATION
REFERENCE RANGE
Calculate the Abs, plot a standard curve & read the concentration of controls &
It is recommended that , each laboratory should establish its own reference values. samples.
The following value may be used as a reference.
serum : 650 - 1600 mg/dL PERFORMANCE CHARACTERISTICS:
Measuring Range:- 90 –2700 mg/dL.
PRECAUTION
If the concentration is greater than 2700 mg/dL , dilute the sample with normal saline
To avoid contamination, use clean laboratory wares, such as pipette tips and test and repeat the assay .Multiply the result with dilution factor.
tubes. Close reagent bottle immediately after use. Avoid direct exposure of reagent
to light. Prozone Effect:- >10000 mg/dL
Precision in CV%:-
SAMPLE Low Medium High
Use fresh serum.
Intra - Run 2.5 3.25 4.18
GENERAL SYSTEM PARAMETERS FOR SEMI AUTO FOR FULLY AUTO Inter - Run 4.08 1.83
Mode of reaction Endpoint Endpoint Accuracy in mg/dL
Slope of reaction Increasing Increasing control Assigned value Measured value
Wavelength 340 nm 340 nm level 1 967(774-1160) 897.3
Temperature o
37 C 37 oC level 2 1745(1396-2094) 1803.5
Calibrator concentration As on vial label x Dilution factor level 3 2643(2114-3171) 2595.7
Linearity 2700 mg/dL 2700 mg/dL INTERFERENCE
Blank Reagent Bank Reagent Bank No interference for
Incubation time 5min + 5min 5min + 5min Hemoglobin upto 1000 mg/dL
Sample volume 5 µL 2 µL Triglyceride upto 2500 mg/dL
Reagent 1 volume 250 µL 150 µL Bilirubin upto 20 mg/dL
Reagent 2 volume 250 µL 150 µL BIBLIOGRAPHY
Cuvette 1 cm light path 1 cm light path 1. Otani,H. :Medical Technology,14, 965(1986)
2. Rinsho Kensa Guide 1992, 269-274(1992), BUNKODO CO., LTD
3. Kanai’s manual of Clinical laboratory Medicine, 30 th edition, 868-873(1993),
KANEHARA & CO.,LTD.

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66
 1 x 30/1 x 10/1 mL
IgA WITH CALIBRATOR 11815001
INTENDED USE CALIBRATION
This reagent is intended for in vitro quantitative determination of IgA antibodies, in Preparation of calibration curve:
serum. Prepare the following calibrator dilutions using normal saline as diluent. Multiply the
-Turbidimetric Immuno assay concentration of the IgA calibrator by the corresponding factor stated in the table
-Linear up to 600 mg/dL below to obtain the IgA concentration of each dilution.
-No sample dilution Dilution 1 2 3 4 5 6
-Ready to use reagents Cali. (µL) - 10 10 20 50 100
-Multipoint calibration Saline (µL) 100 150 70 60 50 -
Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
CLINICAL SIGNIFICANCE
The measurement of IgA is important for typing immunodeficiencies and myelomas. LABORATORY PROCEDURE FOR FULLY AUTO ANALYZER
Further more it plays a role in acute and chronic infections as first line of defence. Blank calibrator Sample/Control
Increased levels may be found in acute infectious hepatitis, chronic aggressive Ig A R 1 180 µL 180 µL 180 µL
hepatitis, cryptogenic cirrhosis, active alcoholic cirrhosis, chronic infections,
rheumatoid arthritis and mixed connective tissue diseases etc. Dil. Calibrator - 2 µL -
PRINCIPLE Sample/control - - 2 µL
Antibodies to IgA are combined with IgA in the patient’s serum, forming immune Mix and incubate for 5 minutes at 37°C. Read the absorbance (A1) at 700 nm.
complexes. The immune complexes cause an increase in light scattering which Ig A R 2 60 µL 60 µL 60 µL
correlate with the concentration of IgA in the serum. The light scattering is Mix and incubate for 5 minutes at 37°C. Measure the absorbance(A2) at 700 nm.
measured by reading turbidity at 700 nm.
ALTERNATIVE PROCEDURE FOR SEMI AUTO ANALYZER:
REAGENT COMPOSITION
Blank calibrator Sample/Control
IgA R1(Buffer solution) 1 x 30 mL
Tris(hydroxymethyl)aminomethane 100 mmol/L Ig A R 1 450 µL 450 µL 450 µL
IgA R2(Antiserum solution) 1 x 10 mL Dil. Calibrator - 5 µL -
Anti-human IgA antiserum Sample/control - - 5 µL
Calibrator 1 x 1 mL Mix and incubate for 5 minutes at 37°C.
Calibrator concentration is mentioned on vial label Ig A R 2 150 µL 150 µL 150 µL
STORAGE AND STABILITY Mix well and incubate for 5 minutes at 37°C. Measure the absorbance against the
The sealed reagents are stable upto the expiry date mentioned on the label when stored reagent blank at 630 nm.
at 2-8oC.
CALCULATION
REFERENCE RANGE Multi point calibration
It is recommended that , each laboratory should establish its own reference values. Calculate the Abs, plot a standard curve & read the concentration of controls &
The following values may be used as reference. samples.
Serum : 110 - 410 mg/dL
PERFORMANCE CHARACTERISTICS:
PRECAUTION Measuring Range:- 1 –600 mg/dL.
To avoid contamination, use clean laboratory wares, such as pipette tips and test If the concentration is greater than 600 mg/dL , dilute the sample with normal saline
tubes. Close reagent bottle immediately after use. Avoid direct exposure of reagent and repeat the assay .Multiply the result with dilution factor.
to light. Prozone Effect:- >6000mg/dL
SAMPLE Precision in CV%:-
Use fresh Serum Low Medium High
Intra - Run 0.84 0.94 1.20
ENERAL SYSTEM PARAMETERS SEMI AUTO FULLY AUTO Inter - Run 1.70 1.41 1.07
Mode of reaction Endpoint Endpoint
Accuracy in mg/dL
Slope of reaction Increasing Increasing
control Assigned value Measured value
Wavelength 630 nm 700 nm
level 1 115(91.7-138) 111.45
Temperature 37oC 37oC
level 2 241(192-289) 240.16
Calibrator concentration As on vial label x Dilution factor
level 3 347(277-416) 351.23
Linearity 600 mg/dL 600 mg/dL
INTERFERENCE
Blank Reagent Blank Reagent Blank
No interference for
Incubation time 5min + 5min 5min + 5min
Hemoglobin 1000mg/dL
Sample volume 5µL 2 µL
Triglyceride 2500 mg/dL
Reagent 1 volume 450 µL 180 µL
Bilirubin 20mg /dL
Reagent 2 volume 150 µL 60 µL
Cuvette 1 cm light path 1 cm light path BIBLIOGRAPHY
Calibration curve Spline Spline 1. K.Bergstorm, et al.: Scand. J. Clin. Lab. Invest., 637(1980)
2. Rinsho Kensa Guide 1992, 269-274(1992), BUNKODO CO. LTD.
3. Kanai’s manual of Clinical laboratory Medicine, 30 th edition, 868-873(1993),
KANEHARA & CO.,LTD

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 1 x 32/1 x 8/1 mL
IgE WITH CALIBRATOR 11818002
INTENDED USE Delay 5 secs -
This reagent is intended for in vitro quantitative determination of IgE in human serum Delta 120 secs -
and plasma samples. sample volume 10 µL 3 µL
-Latex enhanced Immunoturbidimetry Reagent 1 volume 400 µL 200 µL
-Linearity upto 1000 IU/mL Reagent 2 volume 100 µL 50 µL
-Ready to use reagents Cuvette 1 cm light path 1 cm light path
-No need to dilute samples
CALIBRATION
-Multipoint calibration
Preparation of calibration curve:
CLINICAL SIGNIFICANCE Prepare the following calibrator dilution using normal saline as diluent. Multiply the
IgE is an immunoglobulin with a molecular weight of approximately 190 KD. It is concentration of the IgE calibrator by the corresponding factors stated in the table
normally present in the blood in trace amounts. IgE, like all immunoglobulins, is below to obtain the IgE concentration of each dilution.
produced by plasma cells in response to antigenic stimuli. However abnormal IgE Dilution 1 2 3 4 5 6
levels often results in the development of clinically important Type 1 allergic Cali. (µL) - 10 10 20 50 100
reactions such as asthma, hay fever, dermatitis and food allergies. Elevated levels
are also seen in cases of parasitic infections, pulmonary aspergillosis, Wiskott- Saline (µL) 100 150 70 60 50 -
Aldrich Syndrome, hepatitis and myeloma. Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
The measurement of IgE in human serum is considered to be useful in the diagnosis, LABORATORY PROCEDURE FOR FULLY AUTO ANALYZER
treatment, assessment of disease progression, or post-operative prognosis for such Blank Calibrator Sample/control
conditions.
IgE R 1 200 µL 200 µL 200 µL
PRINCIPLE
Dil. Calibrator - 3 µL -
When an antigen-antibody reaction occurs between IgE and anti-IgE antibody which
has been coated on latex particles, agglutination results. This agglutination is Sample/control - - 3 µL
detected as an absorbance change, with the magnitude of the change being IgE R2 50 µL 50 µL 50 µL
proportional to the quantity of IgE in the sample. The actual concentration is then
determined by interpolation from a calibration curve prepared from calibrators of Mix and read absorbance (A1)immediately and after 2 minutes (A2) at 570 nm and
known concentration. 800 nm.
REAGENT COMPOSITION ALTERNATIVE PROCEDURE FOR SEMI AUTO ANALYZER:
IgE R1 1 x 32 mL Blank calibrator Sample/Control
Glycine buffer solution Ig E R 1 400 µL 400 µL 400 µL
IgE R2 1 x 8 mL Dil. Calibrator - 10 µL -
Latex suspension Sample/control - - 10 µL
0.125 % w/v suspension of latex Ig E R2 100 µL 100 µL 100 µL
particles sensitized with anti IgE
Mix and measure the absorbance(A1) immediately and after 2 minutes (A2) against
antibodies (mouse) the reagent blank at 578 nm.
Calibrator 1 x 1 mL
Calibrator concentration is mentioned on vial label CALCULATION
Multi point calibration
STORAGE AND STABILITY Calculate the abs and plot a standard curve & read the concentration of controls &
The reagents are stable until expiry date when kept at 2-80 C. DO NOT FREEZE samples.
REFERENCE RANGE PERFORMANCE CHARACTERISTICS:
It is recommended that each laboratory should establish its own reference values. Measuring Range:- 25 –1000 IU/mL.
The following values may be used as guide line. If the concentration is greater than 1000 IU/mL , dilute the sample with normal
Less than 1 year old 1.35 - 19.5 IU/mL saline and repeat the assay .Multiply the result with dilution factor.
1 -3 yrs 5.24 - 30.0 IU/mL Prozone Effect:- >50000IU/mL
4 -6 yrs 5.20 - 112.0 IU/mL Precision in CV%:-
6 - 9 yrs 13.12 - 142.0 IU/mL Low Medium High
10 - 12 yrs 11.2 - 172.0 IU/mL Intra - Run 1.18 0.36 0.82
13 - 18 yrs 25.0 - 126.00 IU/mL Inter - Run 4.56 1.88 1.21
> 19 yrs 28.00 - 140.0 IU/mL
Accuracy in IU/mL
PRECAUTION control Assigned value Measured value
To avoid contamination, use clean laboratory wares. Use clean, dry disposable pipette Control level 1 46.9(37.5-56.3) 44.8
tips for dispensing. Close reagent bottles immediately after use. Avoid direct exposure Control level 2 92.5(74-111) 89.8
of reagent to light.
Control level 3 138(111-166) 134.85
SAMPLE INTERFERENCE
Use Serum / Plasma No interference for
Hemoglobin upto 1000 mg/dL
GENERAL SYSTEM PARAMETERS SEMI AUTO FULLY AUTO Triglyceride upto 2500 mg/dL
Mode of reaction Fixed time Fixed time Bilirubin upto 20 mg/dL
Slope of reaction Increasing Increasing
BIBLIOGRAPHY
Wavelength 578nm 570nm/ 800nm
1. Human neutrophils synthesize IL-8 in an IgE-mediated activation Monteseirin, J.
Temperature 37 oC 37 oC et al. J Leukoc Biol. 76: 692-700, 2004
Calibrator concentration As on vial label x Dilution factor 2. Myeloperoxidase release after allergen-specific conjunctival challenge
Linearity 1000 IU/mL 1000 IU/mL Monteseirin, J. et al. J Asthma. 41: 639-643, 2004
Blank Reagent Blank Reagent Blank 3. IgE-dependent release of myeloperoxidase by neutrophils from allergic patients
Monteseirin, J. et al. Clin Exp Allergy. 31 (6): 889-891, Jun 2001

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68
 1 x 20/1 x 4/1 mL
LIPOPROTEIN (a) WITH CALIBRATOR 11804001
INTENDED USE Multiply the Lp(a) calibrator concentration by the corresponding dilution factor
This reagent is intended for in vitro quantitative determination of Lipoprotein (a) in indicated in the table to obtain the Lp(a) concentration of the different (diluted)
serum. calibrators.
-Multipoint calibration with fixed time mode LABORATORY PROCEDURE
-Linearity up to 80 mg/dL Calibrator Sample/Control
CLINICAL SIGNIFICANCE R 1 Buffer 800 µL 800 µL
Lp(a) is a low density lipoprotein like particle containing apoliprotein B-100 R 2 Buffer 200 µL 200 µL
disulphide-linked to one large glycoprotein called apoliprotein(a). Many investigators
have confirmed that a high lipoprotein(a) concentration represents an indicator of risk Calibrator 15 µL -
for cardio vascular diseases, especially when, the serum LDL-cholesterol or apo B are Sample - 15 µL
elevated. The quantification of Lp (a) in serum or plasma is important for identification Mix and read the absorbance against blank after 10 seconds (A1) and after 4 minutes
of individuals at risk for developing artherosclerosis. (A2) of the latex addition.
PRINCIPLE CALCULATION
Latex particles coated with anti-human Lp(a) are agglutinated when mixed with samples Calculate the absorbance differences (A2-A1) of each diluted Lp(a) calibrator and plot
containing Lp(a). The agglutination causes an absorbance change dependent upon the the values against the Lp (a) concentration in a calibration curve. Lp (a) concentration
Lp(a) concentration of the patient sample, that can be interpolated in a calibration in the sample is calculated by interpolation of (A2-A1) value on the calibration curve.
curve prepared with different calibrators of different Lp(a) contents.
PERFORMANCE CHARACTERISTICS
REAGENT COMPOSITION
1. Measurement Range: 12-80 mg/dL
LIPOPROTEIN (a) R1 1 x 20 mL If the concentration is greater than linearity (80 mg/dL), dilute the sample and
Buffer solution (pH 8.3) repeat the assay. Multiply the result with dilution factor.
LIPOPROTEIN (a) R2 1 x 4 mL 2. Prozone effect: No prozone effect was detected up to 225 mg/dL.
Lipoprotein (a) latex INTERFERENCES
LIPOPROTEIN (a) CALIBRATOR 1 x 1 mL Bilirubin : up to 427 mmol/L no interference
Calibrator concentration as on the vial label Hemoglobin : up to 10 g/L no interference
STORAGE AND STABILITY Lipids : up to 5 g/L no interference
The sealed reagents are stable up to the expiry date stated on the label, when stored BIBLIOGRAPHY
at 2- 80C. DO NOT FREEZE 1. Gaubalz, J. W. et al. J.Biol Chem 1983; 258 45832 -4589
NORMAL RANGE 2. Berg, K. A. Acta Pathol Microbiol Scand 1963:59:369-382
It is recommended that each laboratory should establish its own reference values. 3. Scanu, A. M. et al. J.Clin invest 1990;85: 1709 -1715
The following value may be used as guide line.
Serum up to 30 mg/dL
PREPARATION AND STABILITY OF REAGENT
Reagent 1 & Reagent 2 are ready to use, should be gently mixed before use.
Calibrator:Reconstitute the calibrator with 1 mL of distilled water & stable for 7 days
at 2-80C.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of to light.
SAMPLE
Fresh Serum sample (free of haemolysis)
GENERAL SYSTEM PARAMETER
Mode of Reaction Fixed time with multicalibrator
Slope of reaction Increasing
Wavelength 570 nm (500-600nm)
Temperature 370C
No of calibrators 5
Calibrator Concentration as on the vial label x Dilution factor
Linearity 80 mg/dL
Blank DI water
Delay time 5 sec
Interval 240 sec
Sample volume 15 µL
Reagent 1 volume 800 µL
Reagent 2 volume 200 µL
Cuvette 1 cm light path
CALIBRATION
Calibration curve : Prepare dilutions of the Lp(a) calibrator using 9 g/L saline as diluent:
Dilution 1 2 3 4 5
Cali. (µL) - 25 50 75 100
Saline (µL) 100 75 50 25 -
Dil. factor 0 0.25 0.5 0.75 1.0

69
 1 x 45/1 x 5/1 mL
MICROALBUMIN TURBILATEX WITH CALIBRATOR 11805001
INTENDED USE GENERAL SYSTEM PARAMETER SEMI AUTO FULLY AUTO
This reagent is intended for in vitro quantitative determination of microalbumin in Mode of reaction Fixed time Rate
urine. Slope of reaction Increasing Increasing
-Turbilatex method with high sensitivity & specificity Wavelength 546 nm 546nm
-Linear up to 150 mg/L Temperature 37 0C 370C
-Single point calibration Calibrator concentration As on vial label As on vial label
CLINICAL SIGNIFICANCE Linearity 150mg/L 150mg/L
The significant increase of albumin concentration in the urine has been used some Blank DI water Reagent blank
years as an indicative value of incipient nephropathy and cardiovascular disease in Delay 2sec --
diabetic patients. Microalbuminuria has also been associated with hypertension and Interval 120 sec --
risk of cardiovascular disease in non-diabetic patients. Microalbuminuria occurs in Sample volume 7µL 3 µL
response to acute inflammatory conditions such as ischemia, trauma and thermal
injury, surgery, pancreatitis and inflammatory bowel disease. In many of these Reagent 1 volume 900 µL 270µL
conditions, albumin excretion increase within minutes or hours of the initiating Reagent 2 volume 100 µL 30µL
stimulus. The degree of microalbuminuria is proportional to the severity of the Cuvette 1 cm light path 1 cm light path
inflammatory process.
LABORATORY PROCEDURE FOR FULLY AUTO ANALYZER
PRINCIPLE Blank Calibrator Sample/control
Latex particles coated with anti human albumin are agglutinated when mixed with MAlb R1 270 µL 270 µL 270 µL
sample containing albumin. The agglutination causes an absorbance change,
dependent upon albumin concentration of the patient sample, that can be quantified Calibrator 3 µL -
by comparison with a calibrator of known microalbumin concentration Sample /control - - 3 µL
REAGENT COMPOSITION Mix and incubate for 5 minutes at 37oC.
MICROALBUMIN R1 1 x 45 mL MAlb R2 30 µL 30 µL 30 µL
Diluent) Mix and read the absorbance immediately (A1), and after 2 minutes (A2) at 546nm.
Glycine buffer (pH 10.0) 100 mmol/L
Sodium azide ALTERNATIVE PROCEDURE FOR SEMI AUTO ANALYZER
MICROALBUMIN R2 1 x 5 mL Calibrator Sample/control
Latex M Alb R1 900 µL 900 µL
Suspension of latex particles Calibrator 7 µL -
Coated with anti human Sample - 7 µL
Albumin (pH 8.2) Malb R2 100 µL 100 µL
Sodium azide 0.95 g/L
Mix and read the absorbance immediately (A1), and after 2 minutes (A2) at 546nm.
MICRO ALBUMIN CALIBRATOR 1 x 1 mL CALCULATION
Microalbumin calibrator concentration is stated on the vial label. (A2-A1) sample
Components of human serum have been tested and found to be negative for the Malb Conc. in mg/L = ------------------------- x Calibrator Conc.
presence of HBs Ag, HCV and of antibody to HIV (1/2). However handle cautiously (A2-A1) calibrator
as potentially infectious.
PERFORMANCE CHARACTERISTICS:
STORAGE AND STABILITY Measuring Range:- 2 - 150 mg/L.
The sealed reagents are stable up to the expiry date stated on the label, when stored If the concentration is greater than 150 mg/L. dilute the sample with normal saline
at 2 - 80C. DO NOT FREEZE. and repeat the assay .Multiply the result with dilution factor.
NORMAL RANGE Prozone Effect:- >1000 mg/L
It is recommended that each laboratory establish its own reference values. Precision in CV%:-
The following value may be used as guide line. Low Medium High
Urine : up to 15 mg/L Intra - Run 2.25 1.48 1.93
PREPARATION AND STABILITY OF REAGENT Inter - Run 2.28 2.06 2.55
Reagent 1 and reagent 2 are ready to use. Accuracy in mg/L
Calibrator : Ready to use. The calibrator is stable until the expiry date on the label when control Assigned value Measured value
stored tightly closed at 2-80C. level 1 19.6(15.7-23.5) 21.2
PRECAUTION level 2 67.2(53.7- 80.6) 69.8
To avoid contamination, use clean laboratory wares. INTERFERENCE
Avoid direct exposure of reagent to light. No interference upto
Hemoglobin 1000 mg/dL
SAMPLE
Creatinine 3 g/L
Fresh urine.
Bilirubin 10 mg/dL
BIBLIOGRAPHY
1. Feldt –Rasmussen, B. et al J Diab Comp 1994; 8; 137 145
2. Panuyiotou, B. N. Journal international Medical Research 1994 ; 22;181,
181-201
3. Bar, J. et al Diabetic Medicine 1995; 12;649-656
4. Gilbert ,R. E. et al Diabetic Medicine 1994; 11;636 - 645
5. Medcalf, E. A. et al. Clin chem. 1990; 36/3; 446-449
6. Young, D. S. Eeffects of drugs on clinical laboratory test, 4th ed. AACC Press, 1995.

ADL/V.02/February 2013

70
 2 x 25 /2 x 5/1 mL
MICROALBUMIN IT WITH CALIBRATOR 11824001
INTENDED USE CALIBRATION
This reagent is intended for in vitro quantitative determination of microalbumin in PREPARATION OF CALIBRATION CURVE
human urine
Prepare the following calibrator dilutions using normal saline as diluent. Multiply the
-Turbidometric Immunoassay concentration of the microalbumin calibrator by the corresponding factor stated in
-Linear up to 395 mg/L the table below to obtain the microalbumin concentration of each dilution.
-Ready to use reagents Dilution 1 2 3 4 5 6
-No need to dilute samples Calib.(µL) - 10 10 25 50 100
-Multipoint calibration Saline(µL) 100 150 70 75 50 -
CLINICAL SIGNIFICANCE Dil. Factor(µL) 0 0.0625 0.125 0.25 0.5 1.0
Albumin is normally found in the blood. When the kidneys are working properly, LABORATORY PROCEDURE FOR FULLY AUTO
albumin will not be present in the urine. However, when the kidneys are damaged, Blank Calibrator Sample /control
small amounts of albumin leak into the urine. This condition is called
microalbuminuria. Microalbumin R 1 200 µL 200 µL 200 µL
Microalbuminuria is most often caused by kidney damage from diabetes. However, Dil.Calibrator - 3 µL -
many other conditions can lead to kidney damage, such as high blood pressure, Sample/control - - 3 µL
heart failure, cirrhosis, or systemic lupus erythematosus (SLE). If early kidney
damage is not treated, larger amounts of albumin and protein may leak into the Mix and incubate for 5 minutes at 37°C. Read the absorbance (A 1) at 340 nm.
urine. This condition is called macroalbuminuria or proteinuria, this can lead to Microalbumin R2 40 µL 40 µL 40µL
chronic kidney disease.
Mix and incubate for 5 minutes at 37°C. Measure the absorbance (A2) at 340 nm.
PRINCIPLE
CALCULATION
The reagents containing polyclonal goat antihuman microalbumin when mixed with
the urine sample containing microalbumin cause changes in absorbance, due to Multipoint calibration
the development of turbidity, which is directly proportional to the concentration Calculate the abs, plot a standard curve & read the concentration of controls &
of microalbumin in the sample. samples.
REAGENT COMPOSITION PERFORMANCE CHARACTERISTICS:
Microalbumin R1 2 x 25 mL Measuring Range:- 4 - 395 mg/L
Saline (9 g/L) If the concentration is greater than linearity (395 mg/L), dilute the sample with
Accelerator normal saline and repeat the assay. Multiply the result with dilution factor.
Sodium azide (0.95 g/L) Prozone Effect:- >6000 mg/L
Microalbumin R2 2 x 5 mL Precision in CV%:-
Phosphate buffered saline Low Medium High
Polyclonal goat anti-human albumin (variable) Intra - Run 2.28 1.8 3.04
Sodium azide (0.95 g/L) Inter - Run 2.93 0.66 0.53
Calibrator 1 x 1 mL Accuracy in mg/L
Calibrator concentration is mentioned on vial label control Assigned value Measured value
STORAGE AND STABILITY level 1 19.6(15.7-23.5) 24.0
The reagents are stable until expiry date when kept at 2-80 C. DO NOT FREEZE! level 2 67.2(53.7- 80.6) 62
INTERFERENCE
NORMAL RANGE
No interference for
It is recommended that each laboratory establish its own reference values.
Hemoglobin upto 1000 mg/dl
The following values may be used as guide line.
Bilirubin upto 10 mg/dL
Urine : 0 -25 mg/L (IFCC)
BIBLIOGRAPHY
PRECAUTION
1. Mount, J. J. Clin. Pathology, 22, 12 (1986)
To avoid contamination, use clean laboratory wares. Use clean, dry disposable pipette 2. Schmidtz, A. et al., diabetic Medicine, 5 , 126 (1988)
tips for dispensing. Close reagent bottles immediately after use. Avoid direct exposure
reagent to light.Do not Freeze.
SAMPLE
Use fresh Urine.

GENERAL SYSTEM PARAMETERS FULLY AUTO

Mode of reaction Endpoint
Slope of reaction Increasing
Wavelength 340 nm
Temperature 37o C
Calibrator concentration As on vial label x Dilution factor
Linearity 395 mg/L
Blank Reagent Blank
Incubation time 5min + 5 min
Sample volume 3 µL
Reagent 1 volume 200 µL
Reagent 2 volume 40 µL
Cuvette 1 cm light path

ADL/V.02/Februay 2013

71
 1 x 30/1 x 3/1 mL
PREALBUMIN WITH CALIBRATOR 11823002
INTENDED USE CALIBRATION
This reagent is intended for in vitro quantitative determination of Prealbumin in Preparation of calibration curve:
human serum Dilute the high concentrated calibrator to 1/10 using normal saline and use this
-Turbidimetric Immunoassay diluted calibrator for the preparation of calibration curve. Prepare the following
-Linear up to 80 mg/dL calibrator dilutions using NaCl as diluent. Multiply the concentration of the
-Ready to use reagents Prealbumin calibrator by the corresponding factor stated in the table below to obtain
the Prealbumin concentration of each dilution.
CLINICAL SIGNIFICANCE Dilution 1 2 3 4 5 6
Prealbumin is a serum and cerebrospinal fluid carrier of thyroid hormone thyroxine Cali. 1/10 dil(µL) - 10 10 20 50 100
(T4) and retinol. So the more accurate name for prealbumin is transthyretin . Saline (µL) 100 150 70 60 50 -
Prealbumin is formed in the liver, it is a measure of hepatocyte function. Decreased Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
and increased levels of serum prealbumin are associated with liver disease and are
affected by the existence and degree of liver diseases. LABORATORY PROCEDURE FOR FULLY AUTO
The half life of prealbumin is approximately 2 days, making prealbumin a more timely Blank Calibrator Sample/control
and sensitive indicator of protein status. Prealbumin R 1 300 µL 300 µL 300 µL
PRINCIPLE Dil. Calibrator - 15 µL -
Antibodies to prealbumin are combined with prealbumin in the patient’s serum, Dil. Sample/control - - 15 µL
forming immune complexes.The immune complexes cause an increase in the light
scattering with the concentration of prealbumin in the serum. The light scattering is Mix and incubate for 5 minutes at 37°C. Read the absorbance (A1) at 340 nm.
measured at 340 nm and 700 nm. Prealbumin R 2 30 µL 30 µL 30 µL
REAGENT COMPOSITION Mix and incubate for 5 minutes at 37°C. Measure the absorbance (A 2) at 340 nm.
Prealbumin R1(Buffer Solution) 1 x 30 mL ALTERNATIVE PROCEDURE FOR SEMIAUTOANALYZER:
Tris (hydroxymethyl) aminomethane 100 mmol/L Blank Calibrator Sample/control
Prealbumin R2 (Anti serum solution) 1 x 3 mL
Prealbumin R 1 500 µL 500 µL 500 µL
Anti- human prealbumin anti serum(Variable)
Calibrator 1 x 1 mL Dil. Calibrator - 25 µL -
Calibrator concentration is mentioned on vial label Dil. Sample/control - - 25 µL
STORAGE AND STABILITY Mix and incubate for 5 minutes at 37°C.
The reagents are stable until expiry date when kept at 2-80 C. DO NOT FREEZE. Prealbumin R 2 50 µL 50 µL 50 µL
NORMAL RANGE Mix and incubate for 5 minutes at 37°C. Measure the absorbance at 340 nm.
It is recommended that each laboratory should establish its own reference values. CALCULATION
The following values may be used as guide line. Calculate the Abs, plot a standard curve & read the concentration of controls &
Male : 23 - 42 mg/dL samples.
Female : 22 - 34 mg/dL PERFORMANCE CHARACTERISTICS:
PRECAUTION Measuring Range:- 5 –80 mg/dL.
To avoid contamination, use clean laboratory wares. Use clean, dry disposable pipette If the concentration is greater than 80 mg/dL , dilute the diluted(1/10)sample with
tips for dispensing. Close reagent bottles immediately after use. Avoid direct exposure normal saline and repeat the assay .Multiply the result with dilution factor.
of reagent to light. Prozone Effect:- >200 mg/dL
SAMPLE Precision in CV%:-
Use fresh serum. Dilute sample/control to 1/10 with saline. Low Medium High
Intra - Run 5.30 3.04 3.96
GENERAL SYSTEM PARAMETERS FOR SEMI AUTO FOR FULLY AUTO Inter - Run 6.22 4.71 4.1
Mode of reaction End point End point Accuracy in mg/dL
Slope of reaction Increasing Increasing control Assigned value Measured value
Wavelength 340 nm 340 nm level 1 15.0(12.0-17.9 15.86
o
Temperature 37 C 37o C level 2 24.7(19.7-29.6) 26.1
Calibrator concentration As on vial label x Dilution factor level 3 32.1(25.7-38.6) 33.2
Linearity 80 mg/dL 80 mg/dL INTERFERENCE
Blank Reagent Blank Reagent Blank No interference upto
Incubation time 5min + 5min 5min + 5min Hemoglobin 1000 mg/dL
Sample volume 25 µL 15 µL Triglyceride 2500 mg/dL
Reagent 1 volume 500 µL 300 µL Bilirubin 20 mg/dL
Reagent 2 volume 50 µL 30 µL
BIBLIOGRAPHY
Cuvette 1 cm light path 1 cm light path
1. Japanese Journal of Clinical Medicine,53(enlarged) ,186 – 188 (1995)
2. Journal of Clinical Experimental Medicine, 149 (5), 277 – 279 (1989)

72
 1 X 45 mL/1 X 5 mL/1 X 2 mL
RF TURBILATEX WITH CALIBRATOR 11803001
PRECAUTION
INTENDED USE
To avoid contamination, use clean laboratory wares. Avoid direct exposure of reagents
This reagent is intended for in vitro quantitative determination of Rheumatoid factor to light.
in serum.
-Linear up to 100 IU/mL SAMPLE
-Multipoint calibration Fresh serum. (Do not use hemolyzed or lipemic serum)
CLINICAL SIGNIFICANCE GENERAL SYSTEM PARAMETERS
Rheumatoid factor are a group of antibodies directed to determinants in the Fc portion Mode of reaction End point
of the immunoglobulin G molecule. Although rheumatoid factors are found in a Slope of reaction Increasing
number of rheumatoid disorders, such as Systemic Lupus Erythematosus(SLE) and Wavelength 650 nm (600-650nm)
Sjogren’s syndrome as well as in non rheumatic conditions. Its central role in clinics Temperature 37 o C
lies in its utility as an aid to the diagnosis of rheumatoid arthritis (RA).
Calibrator concentration As on vial label x 0.3
PRINCIPLE Linearity 100 IU/mL
The RF agglutination assay is a quantitative turbidimetric assay for measurement of Blank Reagent blank
RF in human serum. Incubation time 2 minnutes
Latex particles coated with human gamma-globulin are agglutinated when mixed with Sample volume 5 µL
samples containing RF. The agglutination causes an absorbance change, dependent
upon the RF concentration of the patient sample, that can be quantified by Reagent1 volume 900 µL
comparison with a calibrator of known RF concentration. Reagent R2 volume 100 µL
Cuvette 1 cm path length
REAGENT COMPOSITION
RF TURBILATEX R1 1 x 45 mL LABORATORY PROCEDURE
Diluent Blank Calibrator Sample/control
Tris buffer 20mmol/L R1 reagent 900 µL 900 µL 900 µL
Sodium azide 0.95g/L Calibrator - 5 µL -
RF TURBILATEX R2 1 x 5 mL Sample/control - - 5 µL
RFLatex:
Reagent R2 100 µL 100 µL 100 µL
Suspension of latex particles coated with
human gamma-globulin. (pH 10.0) Mix and incubate exactly 2 minutes at 37oC. Measure the absorbance of calibrator
and sample against reagent blank.
Sodium azide 0.95g/L
RF CALIBRATOR 1 X 2 mL CALCULATION
PRECAUTIONS: Components from human origin have been tested and found to be Single point calibration
negative for the presence of HbsAg, and HCV and of antibody to HIV (1/2). However RF concentration in IU/mL =(Abs of sample /Abs of calibrator) x dil. calib con.
handle cautiously as potentially infectious. Multipoint calibration
STORAGE & STABILITY Calculate the difference in absorbance of each diluted calibrator from reagent blank
The sealed reagents are stable up to the expiry date stated on the label, when stored and plot the values obtained against the RF concentration of each dilution on the
at 2-8oC. DO NOT FREEZE. calibration curve.
RF concentration in the sample is calculated by interpolation (abs sample-abs blank)
NORMAL RANGE in the calibration curve.
It is recommended that each laboratory establish its own reference value. The following
value may be used as guideline. PERFORMANCE CHARACTERISTICS
Serum : up to 20 IU/mL Measuring Range
Multipoint calibration : 20-160 IU/mL
PREPARATION AND STABILITY OF REAGENT
Single point : up to 100 IU/mL.
Reagent R1 and Reagent R2 are ready to use.
If the concentration is greater than linearity, dilute the sample with normal saline and
RF calibrator: Reconstitute with 2mL distilled water. Stable for 30 days at 2-80C. repeat the assay. Multiply the result with dilution factor.
Dilution of calibrator for calibration curve. Prozone effect: No prozone effect was detected up to 800 IU/mL.
Prepare the following calibrator dilutions with normal saline as diluent. Multiply the
concentration of the RF calibrator by the corresponding factor stated in the table to INTERFERENCES
obtain RF concentration of each dilution. No interference for
Dilution 1 2 3 4 5 6 Bilirubin --- up to 20mg/dL
Cali. (µL) - 10 30 50 75 100 Hemoglobin --- up to 10 g/L
Saline (µL) 100 90 70 50 25 - Lipids --- up to 10 g/L
Dil. factor 0 0.1 0.3 0.5 0.75 1.0 BIBLIOGRAPHY
For single point calibration (linear up to 100IU/mL): Prepare the RF calibrator dilution Frederick Wolfe et al; Arthritis and Rheumatism 1991: 34: 951-960.
as follows.
30µLRF calibrator + 70µL normal saline
Multiply the RF calibrator concentration by 0.3 to obtain the concentration of the
diluted calibrator.

ADL/V.02/February 2013

73
 1x 24 /1 x 8 / 1 mL, 2x 24 /2 x 8 / 2 mL
RF LEIT WITH CALIBRATOR 11809003, 11809004
INTENDED USE CALIBRATION
This reagent is intended for in vitro quantitative determination of Rheumatoid factor Preparation of calibration curve:
in Serum. Prepare the following calibrator dilutions using normal saline as diluent. Multiply
-Latex enhanced immunoturbidimetry the concentration of the RF calibrator by the corresponding factor stated in the table
below to obtain the RF concentration of each dilution.
-Linear upto 135 IU/mL
Dilution 1 2 3 4 5 6
-No sample dilution required
Cali. (µL) - 10 20 50 75 100
-Ready to use reagents
Saline (µL) 100 70 60 50 25 -
CLINICAL SIGNIFICANCE Dil. factor 0 0.125 0.25 0.5 0.75 1.0
Rheumatoid Factor (RF) is an auto antibody against human IgG commonly seen in sera
of patients with rheumatoid arthritis. The measurement of RF value is useful in LABORATORY PROCEDURE FOR FULLY AUTO ANALYZER
evaluating the diagnosis, effects of therapy and prognosis of RA, systemic lupus Blank Calibrator Sample /control
erythematosus, Chronic hepatopathy etc. RF R1 210 µL 210 µL 210 µL
PRINCIPLE Dil.Calibrator 8 µL -
When a sample containing rheumatoid factor is added to denatured human IgG which Sample/control - - 8 µL
has been sensitized to latex particles, antigen-antibody reaction occurs leading to
agglutination. This agglutination leads to an absorbance change which is measured at Mix and incubate for 5 minutes at 37oC.
(550 to 660nm). The change in absorbance is proportional to agglutination and the RF R2 70 µL 70 µL 70 µL
actual concentration is determined by interpolation from a calibration curve prepared Mix and read the absorbance immediately (A1), and after 2 minutes (A2) at 660nm.
from known value calibrators.
REAGENT COMPOSITION ALTERNATIVE PROCEDURE FOR SEMI AUTO ANALYZER
RF R 1 1 x 24 mL, 2 x 24 mL Calibrator Sample/control
Glycine Buffer Solution RF R1 450 µL 450 µL
RF R2 1 x 8 mL, 2 x 8 mL Dil.Calibrator 10 µL -
Latex suspension coated with denatured human IgG Sample /control - 10 µL
CALIBRATOR 1 x 1 mL, 1 x2 mL RF R2 150 µL 150 µL
RF calibrator concentration as on vial label. Mix and read the absorbance immediately (A1), and after 2 minutes (A2) at 578nm.
STORAGE AND STABILITY CALCULATION
The sealed reagents are stable up to the expiry date stated on the label, when stored Multipoint calibration
at 2- 80C. DO NOT FREEZE.
Calculate the abs, plot a standard curve & read the concentration of controls &
NORMAL RANGE samples,by interpolation of curve.
It is recommended that each laboratory should establish its own reference values. PERFORMANCE CHARACTERISTICS:
The following value may be used as guide line. Measuring Range:- 10 - 135 IU/mL.
Serum up to 18 IU/mL If the concentration is greater than 135 IU/mL, dilute the sample with normal saline
PREPARATION OF REAGENT and repeat the assay .Multiply the result with dilution factor.
Reagent 1 and Reagent 2 are ready to use Prozone Effect:- >770 IU/mL
RF Calibrator : Ready to use Liquid stable Precision in CV%:-
Low High
PRECAUTION
Intra - Run 5.0 1.0
To avoid contamination, use clean laboratory wares. Avoid direct exposure of reagent
to light & heat. Inter - Run 8.0 5.0
The reagent should be used according to this pack insert. If used otherwise, Accuracy in IU/mL
appropriate performance is not guaranteed. control Assigned value Measured value
level 1 23.8(19-28.5) 20.1
SAMPLE
level 2 28.4(22.7-34) 30.81
Fresh serum (Do not use haemolized or lipemic serum)
level 3 37.9(30.3-45.5) 41.96
IINTERFERENCE
GENERAL SYSTEM PARAMETER SEMI AUTO FULLY AUTO
No interference upto
Mode of Reaction Fixed Time End point
Hemoglobin 500 mg/dL
Slope of reaction Increasing Increasing
Intrafat 5000 mg/dL
Wavelength 578 nm 660 nm
Bilirubin 20 mg/dL
Temperature 370C 37 0C
No.of calib. 6 6 BIBLIOGRAPHY
Calibrator concentration As on vial label x Dilution factor Frederick Wolfe et al-Arthritis and Rheumatism 1991 : 34:951-960
Linearity 135 IU/mL 135 IU/mL
Blank DI water Reagent blank
Delay 5 sec --
Interval 120 sec --
Sample volume 10 µL 8 µL
Reagent 1 volume 450 µL 210 µL
Reagent 2 volume 150 µL 70 µL
Cuvette 1 cm light path 1 cm light path

74
 1 x 30/1 x3/1 mL
TRANSFERRIN WITH CALIBRATOR 11821002
INTENDED USE LABORATORY PROCEDURE FOR FULLY AUTO
This reagent is intended for in vitro quantitative determination of Transferrin in Blank Calibrator Sample/control
human serum
Transferrin R1 300 µL 300 µL 300 µL
-Turbidimetric Immunoassay
-Linear up to 540 mg/dL Dil. Calibrator - 8.5 µL -
-Ready to use reagents Dil. Sample/control - - 8.5 µL
-Multipoint calibration Mix and incubate for 5 minutes at 37°C. Read the absorbance (A1) at 340 nm.
CLINICAL SIGNIFICANCE Transferrin R2 30 µL 30 µL 30 µL
Transferrin(TF) is synthesised in Liver. The main role of Transferrin is to deliver iron Mix and incubate for 5 minutes at 37°C. Measure the absorbance (A 2) at 340 nm.
from absorption centres to all tissues. Increased serum Transferrin is associated with
iron deficiency anemia, malignant tumor, polycythemia rubra, aplastic anemia, ALTERNATIVE PROCEDURE FOR SEMIAUTOANALYZER:
hemolytic anemia and hepatitis. Absence of Transferrin in the body creates a rare Blank Calibrator Sample/control
genetic disorder known as atransferrinemia; a condition characterized by anemia and Transferrin R1 500 µL 500 µL 500 µL
hemosiderosis in the heart and liver that leads to many complications including heart
failure. Dil. Calibrator - 15 µL -
Dil. Sample/control - - 15 µL
PRINCIPLE
Antibodies to human TF are combined with transferrin in the patients serum, forming Mix and incubate for 5 minutes at 37°C.
immune complexes. The immune complexes cause an increase in light scattering which Transferrin R 2 50 µL 50 µL 50 µL
correlate with the concentration of TF in the serum. The light scattering is measured Mix and incubate for 5 minutes at 37°C. Measure the absorbance (A) at
340 nm.
340 nm against reagent blank.
REAGENT COMPOSITION
CALCULATION
Transferrin R1(Buffer solution) 1 x 30 mL
Calculate the Abs, plot a standard curve & read the concentration of controls &
Tris (hydroxymethyl) aminomethane 100 mmol/L samples.
Transferrin R2(Anti serum solution) 1 x 3 mL
Anti- human TF anti serum (Variable) PERFORMANCE CHARACTERISTICS:
Calibrator 1 x 1 mL Measuring Range:- 40 – 540 mg/dL.
Calibrator concentration is mentioned on vial label If the concentration is greater than 540 mg/dL , dilute the diluted(1/10)sample with
normal saline and repeat the assay .Multiply the result with dilution factor.
STORAGE AND STABILITY Prozone Effect:- >1400 mg/dL
The reagents are stable until expiry date when kept at 2-80 C . Precision in CV%:-
NORMAL RANGE Low Medium High
It is recommended that each laboratory establish its own reference values. Intra - Run 4.78 1.30 0.78
The following values may be used as guide line. Inter - Run 4.64 2.46 0.9
Male : 190 - 300 mg/dL Accuracy in mg/dL
Female : 200 - 340 mg/dL control Assigned value Measured value
PRECAUTION level 1 151(121-181) 160.48
To avoid contamination, use clean laboratory wares. Use clean, dry disposable pipette level 2 250(200-300) 254.54
tips for dispensing. Close reagent bottles immediately after use. Avoid direct exposure level 3 334 (267 - 400) 351.3
of reagent to light.
INTERFERING SUBSTANCES
SAMPLE No interference for
Use fresh serum. Dilute serum/control to 1/10 with saline. Hemoglobin upto1000 mg/dL
Bilirubin upto20 mg/dL
GENERAL SYSTEM PARAMETERS FOR SEMI AUTO FOR FULLY AUTO Lipemia upto5 % of intralipid
Mode of reaction End point End point
Slope of reaction Increasing Increasing BIBLIOGRAPHY
Wavelength 340 nm 340 nm 1. K. Bergstorm, et al.: Scand. J.Clin Lab Invest., 40, 637- 640 (1980)
2. H. Maikus, et al.: Clinica Chemica Acta, 88, 523- 530(1978)
Temperature 37 oC 37 oC
Calibrator concentration As on vial label x Dilution factor
Linearity 540 mg/dL 540 mg/dL
Blank Reagent Blank Reagent Blank
Incubation time 5min + 5min -
Sample volume 15 µL 8.5 µL
Reagent 1 volume 500 µL 300 µL
Reagent 2 volume 50 µL 30 µL
Cuvette 1 cm light path 1 cm light path
CALIBRATION
Preparation of calibration curve:
Dilute the high concentrated calibrator 1/10 with normal saline and use this diluted
calibrator for the preparation of calibration curve.
Prepare the following calibrator dilutions using normal saline as diluent. Multiply the
concentration of the Transferrin calibrator by the corresponding factors stated in the
table below to obtain the Transferrin concentration of each dilution.
Dilution 1 2 3 4 5 6
1/10dilcali.(µL)| - 10 10 25 50 100
Saline (µL) 100 150 70 75 50 -
Dil. factor 0 0.0625 0.125 0.25 0.5 1

75
 50 T, 100 T
ASO 12201002, 12201003
INTENDED USE: This reagent is intended for in vitro qualitative & semi quantitative SEMI – QUANTITATIVE TEST
determination of Anti Streptolysin O (ASO) in serum. In the cases in which it is desired to find out the titre of a positive sample, it is possible
-No prozone effect detected up to 1500 IU/mL by the serial dilution methodology.
-Rapid procedures; test time only 2 minutes 1. Place 50 µL diluted physiological saline Buffer onto each of five circles of the slide
-Excellent clarity; clear agglutination 2. Using a 50 µL micro pipette add 50 µL of the serum sample to the drop of saline
CLINICAL SIGNIFICANCE buffer in 1st circle.
3. Using the same micro pipette, mix the sample with saline by aspirating back &
Streptolysin O is a toxic immunogenic exoenzyme produced by ß-haemolytic forth several times. Aspirate 50 µL from 1st circle and transfer to 2 nd circle.
Streptococcus group A, C and G. ASO antibodies are useful for the diagnosis of Repeat the same operation up to 5th circle. Aspirate 50 µL from 5th circle and
rheumatoid fever, acute glomerulonephritis and streptococcal infections. Rheumatic discard. Dilutions obtained as 1/2, 1/4 1/8, 1/16, 1/32
fever is an inflammatory disease affecting connective tissue from several parts of 4. Then add 1 drop of ASO latex to the above circles. Mix and rock the slide gently to
human body as skin, heart, joints etc. Acute glomerulonephritis is a renal infection and fro for 2 minutes; observe the agglutination under good source of light.
that affects mainly glomerulus.
CALCULATION
PRINCIPLE
ASO Conc. (IU/mL) = sensitivity x Titre (Highest dilution serum showing agglutination)
ASO latex kit is a rapid agglutination procedure for the direct detection and semi-
quantitation (on slide) of antistreptolysin-O (ASO). The antigen, latex particles Where, ASO sensitivity = 200 IU/mL
suspension coated with Streptolysin-O, agglutinates in the presence of specific NOTE:
antibodies present in the sera of patients with streptolysin O. 1. False positive results may be obtained in conditions such as rheumatoid arthritis,
scarlet fever, several other streptococcal healthy carriers.
REAGENTS & MATERIALS PROVIDED 2. Early infections and children from 6 months to 2 years may cause false negative
ASO LATEX 1 x 2.5 mL / 1 x 5 mL results.
Suspension of polystyrene particles coated with Streptolysin-O. 3. A single ASO determination does not produce much information about the
ASO POSITIVE CONTROL 1 x 0.5 mL actual state of the disease. Titrations at bi weekly intervals during 4 or 6 weeks
Human pooled serum are advisable to follow the disease evolution.
ASO NEGATIVE CONTROL 1 x 0.5 mL PERFORMANCE CHARACTERISTICS
Human pooled serum 1. Diagnostic sensitivity : 98%
PHYSIOLOGICAL SALINE BUFFER CONCENTRATE 1 x 5 mL 2. Diagnostic specificity : 97%
3. Prozone effect: No prozone effect detected up to 1500 IU/mL.
Dilute 1:20 (v/v) with distilled water Interferences
ACCESSORIES: for 50T for 100 T Hemoglobin : 10 g/L
1. Reaction slide 1 1 Bilirubin : 20 mg/dL
2. Serum droppers 50 100 Rheumatoid factor : 300 IU/mL
3. Applicator sticks 50 100 do not interfere. Other substances may interfere4.
4. Rubber teat 1 1 BIBLIOGRAPHY
PRECAUTION 1. CURTIS G. D.W, KRAAK W.A.G., MITCHELL R.G. Comparison of latex and
Reagent components of human origin have been tested and found to be negative hemolysis test determination of antistreptolysin O (ASO) antibodies. J. Clin.
for the presence of antibody to HIV (1/2) as well as for HBsAg and HCV antibody. Pathol. 41, 1331 (1988)
However, handle cautiously as potentially infectious. 2. TADZYNSKY L.A., RYAN M.E. Diagnosis of rheumatoid fever. A guide to criteria
The reagent and controls contain less than 0.1% sodium azide. and manifestations. Post grad Med. 79, 295 (1986)
STORAGE AND STABILITY 3. D’ANGELO W.A. Rheumatic Diseases. Diagnostic tests and procedures. in: The
When stored at 2-80C and protected from light, the reagent and the controls are Laboratory in Clinical Medicine (Halsted J.A. Ed.) Saunders Company,
stable until the expiry date stated on the label. DO NOT FREEZE Philadelphia, chapter 29 (1976)
4. Young D.S., Effects of Drugs on Clinical Laboratory Test 4th ed. AACC Press, 1995.
Preparation of physiological saline buffer: Prepare physiological saline buffer by
adding 95mL of distilled water to 5 mL of physiological saline buffer concentrate
(provided). It is stable up to expiry date, when stored at room temperature.
ANALYTICAL SENSITIVITY
The ASO latex reagent sensitivity has been adjusted to detect a minimum of
200 (+/- 50) IU/mL ASO antibodies in the undiluted samples.
SAMPLE
Fresh serum (free of haemolysis)
QUALITATIVE TEST
Allow all reagents as well as the sample to reach room temperature. Mix well before
use.
1. Place 1 drop of serum sample on the slide using a disposable serum dropper.
2. Add one drop of ASO-latex reagent to the above drop and mix with disposable
applicator stick.
3. Rock the slide gently to and fro for 2 minutes and immediately examine under
a good light source for agglutination, do not examine beyond 2 minutes.
4. For positive & negative controls follow the same procedure as mentioned above
by taking control serum from respective vials.
RESULT AND INTERPRETATION
Positive result:
The presence of agglutination indicate concentration of ASO in the sample equal
or greater than 200 IU/mL (above normal).
Negative result:
The lack of agglutination indicates ASO level lower than 200 IU/mL in the sample,
(within the normal range).

ADL/V.02/February 2013

76
 50 T, 100 T
CRP 12202002, 12202003
INTENDED USE: This reagent is intended for in vitro quantitative determination of SEMI – QUANTITATIVE TEST
C-reactive protein (CRP) in serum In the case in which it is desired to find out the titre of a positive sample, it is
-No prozone effect detected up to 1600 mg/L possible by the serial dilution methodology.
-Rapid procedure, only 2 minutes test 1. Place 50 µL diluted saline Buffer onto each of five circles of the slide.
-Excellent clarity, clear agglutination 2. Using a 50 µL micro pipette add 50 µL serum sample to the drop of saline
CLINICAL SIGNIFICANCE buffer in 1st circle.
3. Using the same micro pipette, mix the sample with saline by aspirating back &
CRP is a classic acute phase protein of human serum, synthesized by hepatocytes. forth several times. Aspirate 50 µL from 1st circle and transfer to 2 nd circle.
Normally it is present only in trace amounts in serum, but it can increase as much Repeat the same operation up to 5th circle. Aspirate 50 µL from 5th circle and
as 1,000 fold in response to injury or infection. The clinical measurement of CRP in discard. Dilutions obtained as 1/2, 1/4, 1/8, 1/16, 1/32
serum therefore appears to be a valuable screening test for organic disease and a 4. Then add 1 drop of CRP latex reagent to the above circles. Mix and rock the slide
sensitive index of disease activity in inflammatory, infections and ischemic conditions. gently to and fro for 2 minutes; observe the agglutination under good source of
PRINCIPLE light.
CRP latex kit is a rapid agglutination procedure for the direct detection and semi- CALCULATION
quantitation (on slide) of C-reactive protein (CRP). The reagent, latex particles Concentration of CRP in serum can be calculated as follows:
suspension coated with specific antihuman C-reactive protein antibodies, CRP Conc. (mg/L) = sensitivity x titre (highest dilution serum showing agglutination)
agglutinates in presence of CRP in patient serum.
Where, CRP sensitivity = 6 mg/L
REAGENTS & MATERIALS PROVIDED NOTE:
CRP LATEX 1 x 2.5 mL / 1 x 5 mL 1. Reaction time is critical, if reaction time exceeds two minutes, drying of reaction
Suspension of polystyrene particles coated with anti human CRP goat antibodies. mixture may cause false positive results.
CRP POSITIVE CONTROL 1 x 0.5 mL 2. Freezing the CRP latex reagent will cause spontaneous agglutination.
Human pooled serum 3. Intensity of agglutination is not necessarily indicative of relative CRP
concentration, therefore screening reaction should not be graded.
CRP NEGATIVE CONTROL 1 x 0.5 mL 4. A false negative can be attributes to a prozone phenmenon (antigen excess). It
Human pooled serum is recommended therefore to check sample with dilution.
PHYSIOLOGICAL SALINE BUFFER CONCENTRATE 1 x 5 mL 5. Clinical diagnosis should not be made on findings of a single test result, but
Dilute 1:20 (v/v) with distilled water should integrate both clinical and laboratory data.
ACCESSORIES: For 50 T For 100 T PERFORMANCE CHARACTERISTICS
1. Reaction slide 1 1 Diagnostic sensitivity : 95.6%
2. Plastic droppers 50 100 Diagnostic specificity : 96.2%
3. Applicator sticks 50 100 Prozone effect : No prozone effect detected up to 1600mg/mL.
4. Rubber teat 1 1 INTERFERENCES
PRECAUTION Bilirubin up to 20 mg/dL
Reagent components of human origin have been tested and found to be negative Hemoglobin up to 10 g/L
for the presence of antibody to HIV (1/2) as well as for HBsAg and HCV antibody. Lipids up to 10 gL
However, handle cautiously as potentially infectious. Rheumatoid factor up to 100 IU/mL
The reagent and controls contain less than 0.1% sodium azide. Do not interfere. Other substances may interfere.
STORAGE AND STABILITY BIBLIOGRAPHY
When stored at 2-80C and protected from light, the reagent and the controls are 1. Wadsworth, C.Wadsworth, E., Efficacy of latex agglutination methods for
stable until the expiry date stated on the label. DO NOT FREEZE. determination of C - reactive protein in Pediatric sera. Clin. Chem. Acta, 138,
Preparation of physiological saline buffer: Prepare physiological saline buffer by (1984), 309
adding 95mL of distilled water to 5mL of physiological saline buffer concentrate 2. Ballou S.P, Kushner, I.C. Reactive Protein and acute phase response. ADV Int.
(provided). It is stable up to expiry date, when stored at room temperature. Med, 37, (1992), 313.
ANALYTICAL SENSITIVITY 3. Young D.S., Effects of Drugs on Clinical Laboratory Test 4th ed. AACC Press, 1995.
The CRP latex sensitivity has been adjusted to detect a minimum of
6 (5-10) mg/L in the undiluted samples.
SAMPLE
Fresh serum (free of haemolysis)
QUALITATIVE TEST
Allow all reagents as well as the sample to reach room temperature. Mix well before
use.
1. Place 1 drop of serum sample on to the slide using a disposable serum dropper.
2. Add one drop of CRP-latex reagent to the above drop and mix well with
disposable applicator stick.
3. Rock the slide gently to and fro for 2 minutes and examine immediately under
good light source for agglutination, do not examine beyond 2 minutes.
4. For positive & negative controls follow the same procedures as mentioned
above by taking control serum from respective vials.
RESULT AND INTERPRETATION
Positive result:
The presence of agglutination indicate concentration of CRP in the sample equal
or greater than 6 mg/L (above normal)
Negative result:
The lack of agglutination indicates CRP level lower than 6 mg/L in the sample,
(within the normal range)

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77
 50 T, 100 T
RF 12203002, 12203003
INTENDED USE: This reagent is intended for in vitro qualitative & semi Negative result:
quantitative determination of Rheumatoid factor (RF) in serum. The lack of agglutination indicates RF level lower than 8 IU/mL in the
-Sensitivity 8 IU/mL sample, (within the normal range).
-Optimized antigen concentration; No prozone effect up to 800 IU/mL SEMI – QUANTITATIVE TEST
-Rapid procedure; only 2 minutes test In the case in which it is desired to find out the titre of a positive sample, it is
-Excellent clarity; crystal clear agglutination feasible by the serial dilution methodology.
CLINICAL SIGNIFICANCE 1. Place 50 µL diluted saline buffer onto each of five circles of the slide
Rheumatoid factors are a group of antibodies directed to the determinants in the Fc 2. Using a 50 µL micro pipette add 50 µL of the serum sample to the drop of saline
portion of the immunoglobulin G molecule (IgG). Although rheumatoid factors are buffer in 1st circle.
found in a number of rheumatoid disorders, such as systemic lupus erythematosus 3. Using the same micro pipette, mix the sample with saline by aspirating back &
(SLE) and Sjogrens syndrome as well as in non rheumatic condition, its central role forth several times. Aspirate 50 µL from 1st circle and transfer to 2 nd circle.
in clinics lies in its utility as an aid in the diagnosis of rheumatoid arthritis (RA). Repeat the same operation up to 5th circle. Aspirate 50 µL from 5th circle and
discard. Dilutions obtained as ½, ¼, 1/8, 1/16, 1/32
PRINCIPLE 4. Then add 1 drop of RF latex reagent to the above circles, mix and rock the slide
RF latex kit is a rapid agglutination procedure for the detection and semi- gently to and fro for 2 minutes; observe the agglutination under good source
quantitation (on slide) of Rheumatoid Factors (RF). The antigen, a latex particles of light.
suspension coated with human gamma-globulin, agglutinates in presence of CALCULATION
rheumatoid factors in the patient serum The Rheumatoid Factor (RF) level in serum can be calculated as follows:
REAGENTS & MATERIALS PROVIDED RF conc. (mg/dL) = sensitivity x titre (highest dilution of serum showing agglutination)
RF LATEX 1 x 2.5 mL / 1 x 5 mL Where, RF Sensitivity = 8.0 IU/mL
Suspension of polystyrene particles coated with human gamma -globulin. PERFORMANCE CHARACTERISTICS
RF POSITIVE CONTROL 1 x 0.5 mL 1. Diagnostic sensitivity : 98%
Human pooled serum 2. Diagnostic specificity : 98.8%
RF NEGATIVE CONTROL 1 x 0.5 mL 3. Prozone effect : No prozone effect was detected up to 800 IU/mL.
Human pooled serum INTERFERENCES
PHYSIOLOGICAL SALINE BUFFER CONCENTRATE 1 x 5 mL Bilirubin up to 20 mg/dL
Dilute 1:20(v/v) with distilled water Hemoglobin up to 10g/L
ACCESSORIES:For 50 T For 100 T Lipids up to 10g/L
1. Reaction slide 1 1 will not interfere. Other substances may interfere.
2. Plastic droppers 50 100 NOTE:
3. Applicator sticks 50 100 1. The incidence of false positive results is about 3-5%. Individuals suffering from
4. Rubber teat (blue) 1 1 infectious mononuclear hepatitis, syphilis as well as elderly people may give
PRECAUTION positive results.
Reagent components of human origin have been tested and found to be negative 2. Diagnosis should not be solely based on the results of latex method, but also
for the presence of antibody to HIV (1/2) as well as for HBsAg and HCV antibody. should be complemented with a Waaler Rose test along with clinical
However, handle cautiously as potentially infectious. examination.
The reagent and controls contain less than 0.1% sodium azide. BIBLIOGRAPHY
STORAGE AND STABILITY 1 . Frederick Wolf et al-Arthritis and Rheumatism 1991: 34: 951-960
When stored at 2-80C and protected from light, the reagent and the controls are 2. Robert W Dorner et al. Clinica Chemica Acta 1987; 167: 1-21
stable until the expiry date stated on the label. DO NOT FREEZE.
Preparation of physiological saline buffer: Prepare saline buffer by adding 95 mL
of distilled water to 5 mL of concentrate saline buffer (provided). It is stable up to
expiry date, when stored at room temperature.
ANALYTICAL SENSITIVITY
The RF sensitivity has been adjusted to detect a minimum of
8.0 IU/mL (6-16) RF in the undiluted samples.
SAMPLE
Fresh serum (free of haemolysis)
QUALITATIVE TEST
Allow all reagents as well as the sample to reach room temperature. Mix well before
use.
1. Place 1 drop of serum sample on to the slide with disposable serum dropper.
2. Add one drop of RF-latex reagent to the above drop and mix well with
disposable applicator stick.
3. Rock the slide gently to and fro for 2 minutes and then examine immediately
under good light source for agglutination, do not examine beyond 2 minutes.
4. For positive & negative controls follow the same procedures as mentioned
aboveby taking control serum from respective vials.
RESULT AND INTERPRETATION
Positive result:
The presence of agglutination indicated concentration of RF in the sample equal
or greater than 8 IU/mL (above normal).

ADL/V.02/February 2013

78
 50 T, 125 T, 500 T
RPR 12204001, 12204002, 12204003
INTENDED USE: RPR (Rapid Plasma Reagin) test is a non-treponemal test for the SEMI – QUANTITATIVE TEST
serological diagnosis of Syphilis. Specificity, reactivity and sensitivity are similar to In the case in which it is desired to find out the titre of a positive sample, it is
that of classical VDRL test. It is a reliable, economical and rapid test and hence possible by the serial dilution methodology.
recommended as a screening test. 1. Place 50 µL diluted saline Buffer onto each of five circles of the slide.
CLINICAL SIGNIFICANCE 2. Using a 50 µL micro pipette add 50 µL serum sample to the drop of saline buffer
Syphilis is a veneral disease caused by the spirochete microorganism T.pallidum. As in 1st circle.
the organism is difficult to be cultured on artificial media, the diagnosis of syphilis 3. Using the same micro pipette, mix the sample with saline by aspirating back &
depends on the correlation of clinical data with the detection of specific antibody forth several times. Aspirate 50 µL from 1st circle and transfer to 2 nd circle.
by serological test. Serological screening tests for syphilis using cardiolipin and Repeat the same operation up to 5th circle. Aspirate 50 µL from 5th circle and
lecithin antigen are simple to perform and reliable but may give rise to small discard. Dilutions obtained as 1/2,1/4, 1/8, 1/16, 1/32
proportion of false positive results because the tests use non treponemal antigens. 4. Then add 1 drop of RPR antigen suspension (18 µL) to the above circles.Mix and
These antigens detect reagin antibodies produced against cardiolipin during an rock the slide gently to and fro for 8 minutes; observe the agglutination under
infection. good light source for appearance of carbon particle clumping.
PRINCIPLE INTERPRETATION
RPR reagent is an antigen containing cardiolipin antigen, sensitized on carbon particles The titre of reagin antibodies is the highest dilution of the test sample which is
which detects reagin antibody present in serum of syphilitic individuals. When a reactive.
specimen contains antibody is mixed with the reagent, flocculation occurs due to NOTE
coagglutination of the carbon particles of the RPR antigen, which appear as black
clumps against the white background of the card. This coagglutination is read 1. As with tests based on reagin antibody detection, the RPR syphilis test may
macroscopically. Non-reactive specimens show a black button at the centre. produce false positive results. These can be linked to diseases such as leprosy,
systemic lupus erythoematosus (SLE), infectious mononucleosis, malaria, viral
REAGENTS AND METERIALS PROVIDED pneumonia. Any positive result must be confirmed by another serological assay
RPR ANTIGEN 1 x 1.1 mL, 1 x 2.6 mL, 4 x 2.6 mL (eg.TPHA) Final diagnosis will only be reached after correlation of the results
Antigen, Cardiolipin suspension containing carbon micro particles. with clinical signs.
2. False negative results may be seen in early and latent stages of the disease.
RPR POSITIVE CONTROL 1 x 0.3 mL 3. Qunatitative procedure must be performed to determine the response to
Human pooled serum treatment and detect re-infection.
RPR NEGATIVE CONTROL 1 x 0.3 mL 4. While dispensing reagents/specimens hold pipette/dropper vertically straight.
Human pooled serum 5. The needle assembly should be thoroughly rinsed with distilled water and air
PHYSIOLOGICAL SALINE 1 x 5mL dried before further use.
6. The test cards must not be reused.
Dilute 1:20 (v/v) with H2O. BIBLIOGRAPHY
ACCESSORIES: For 50 Tests For 125 Tests For 500 Tests 1. Caumes E., Janier M. Syphilis, editions techniques. Encyclo. Med Chir (Paris
1.Applicator stick 50 125 500 France) Maladies Infectiouses. 8-039 -A-10(1994)
2. Serum dropper 50 125 500 2. Drustin L.M. syphilis. Curr OPN. Infect Dis2 : 11-15 (1989)
3. Plastic slides 7 16 63
4. Dropper with needle 1 set 1 set 1 set
( Accessories will be provided in separate pouch)
PRECAUTION
Reagent components of human origin have been tested and found to be negative
for the presence of antibody to HIV (1/2) as well as for HBsAg and HCV antibody.
However, handle cautiously as potentially infectious.
The reagent and controls contain less than 0.1% sodium azide.
STORAGE AND STABILITY
When stored at 2-80C and protected from light, the reagent and the controls are
stable until the expiry date stated on the label. DO NOT FREEZE.
Preparation of saline buffer: Prepare saline buffer by adding 95 mL distilled water
to 5 mL concentrated saline buffer. It is stable up to expiry date when stored at
room temperature.
SAMPLE
Fresh serum (free of haemolysis)
QUALITATIVE TEST
Bring the test reagents and samples to room temperature
1. Place 1 drop of serum sample (50 µL or 0.05mL) on to the slide with disposable
serum dropper.
2. Place one drop of RPR antigen suspension (18 µL) by antigen dropper
3. Mix well and spread the liquid over the entire area of the circle using disposable
applicator stick
4. Rock the slide gently to and fro for 8 minutes on a mechanical rotator& observe
immediately under good light source for the appearance of carbon particle
clumping.
RESULT AND INTERPRETATION
Medium & large aggregates against white back ground - - Reactive
Small agglutinates around periphery - Weak reactive
No aggregates, button formation at the centre of circle - Non reactive

ADL/V.03/February 2013

79
 Blood GROUPING
1 x 10 mL
ANTI - A 13601010
INTENDED USE
This reagent is a monoclonal antibody solution intended for determination of red cells
having A antigen on the surface, who are categorized as A group individuals.
- Monoclonal antibody technology
- High avidity and high titre
- Convenient pack sizes
PRINCIPLE
This technique employs the principle of hemagglutination. When the red blood cells
bearing the A antigens are mixed with the Anti-A solution, if agglutination occurs
indicates the presence of A antigen, and the individual belongs to A group and if no
agglutination occurs indicated absence of A antigen.
REAGENT COMPOSITION
Anti A is ready to use reagent prepared from supernatents of mouse hybridoma cell
culters. These reagents contain sodium azide (<0.1%), sodium arsenite (0.02%) and
bovine albumin.
STORAGE AND STABILITY
The sealed reagent is stable up to expiry date stated on the vial label, when stored at
2-80C. It is advisable to minimize its time outside the refrigerator between two uses.
SAMPLE
Whole blood sample must be examined with in 48 hrs. Samples should be stored at
2-80C, if not tested immediately. Do not use haemolysed samples.
LABORATORY PROCEDURE
PLATE TECHNIQUE AT ROOM TEMPERATURE
Bring the reagents to room temperature. Place one drop of Anti-A reagent on a clean
slide, and then add one small drop of whole blood. Mix well with a mixing stick
uniformly. Rock the slide gently back and forth for about 3 minutes while
macroscopically observing the possible appearance of agglutination.
DIRECT METHOD IN A TUBE AT ROOM TEMPERATURE
Prepare a 5% suspension of red blood cells in isotonic saline solution. Using the vial
dropper, place one drop of Anti-A reagent in to labeled test tube. Add a drop of 5 %
RBC suspension. Shake to homogenize the mixture, then centrifuge at 1000 RPM for
60 seconds. Read macroscopically for appearance of any agglutination.
INTERPRETATION
If there is agglutination (ie clumping of red blood cells) the test result indicates the
presence of A antigen.
If there is no visible agglutination, (ie clumping is absent), the test result indicates the
absence of A antigen.
NOTE:
For getting high titre use ABD dilution buffer (code.13601330). The ABD dilution
buffer will be provided on request.
BIBLIOGRAPHY
1. Mannessier, L.; Blood transfusion center Lille France. The use of monoclonal
antibodies as blood grouping reagents: applications, advantages and problems.
Congress of the Italian society for blood transfusion –Rome-June 1992.
2. Blood group serology, Boorman, Dodd and Lincol Churchil Livingstone 6th edition.
3. Human blood groups, Geoff Daniela, 1st edition Blackwell Science, Oxford 1995.

80
 Blood GROUPING
3 x 10 mL
ANTI - A, B & D (IgG+IgM) 13601001
INTENDED USE If there is no agglutination (red blood cells form a homogenous suspension), the
This reagent is intended for in vitro determination of ABO group and Rh typing of reaction is negative and the antigen is not present on the red blood cells.
human red blood cell antigens. In case of anti D agglutination a positive test indicates presence of Rh antigen i.e. Rh
- Monoclonal antibody technology positive. No agglutination or a negative test indicated either presence weaker variants
- Highly specific of Rh antigens like Du or absence of Rh antigen. This needs confirmation by carrying
out indirect coomb’s test.
- Convenient slide and tube formats.
Drying at the periphery or fibrin strands should not be misinterpreted as agglutination.
CLINICAL SIGNIFICANCE
The ABO grouping is defined by both, the presence of ‘A’ and/or ‘B’ antigens on the NOTE:
surface of the red blood cells, and by simultaneous presence of Anti-A and or Anti-B For getting high titre use ABD dilution buffer.(code.13601330). The ABD dilution
antibodies in the serum. An individual has in his serum the antibodies corresponding buffer will be provided on request.
to the antigens which are not present on his red blood cells.
Based on the principle of hemagglutination, human red blood cells possessing ‘A’ and
/or ‘B’ antigen will agglutinate in the presence of corresponding antibody directed BIBLIOGRAPHY
towards the antigen. 1. Common Technical Specifications (CTs) for the in vitro diagnosis medical devices
Human red blood cells are classified as Rh positive (Rh+) or Rh negative (Rh-) depending of annex II, list A, of directive 98/79/EC are notified in the official journal of the
upon the presence or absence of ‘D’ antigen on them. Red blood cells possessing D European communities under document No.C (2202) 1344, with EEA relevance
antigen will agglutinate in the presence of reagent containing corresponding antibody. (2202/364/CE)
2. Mannessier .L Blood transfusion center Lille France. The use of monoclonal
REAGENT COMPOSITION antibodies as blood grouping reagents: applications, advantages and problems.
Anti-A, Anti-B and Anti-D are ready to use reagents prepared from supernatents of Congress of the Italian society for blood transfusion –Rome-June 1992.
mouse hybridoma cell cultures. These antibodies of immunoglobin class IgM (Anti- 3. Blood group serology, Boorman, Dodd and Lincoln, Churchill Livingstone, 6th
D IgM+IgG) are a mixture of several monoclonal antibodies of the same specificity edition.
but having capacity of recognising different epitopes of human red blood cell 4. Human blood groups, Geoff Daniels, 1st edition, Blackwell Science, Oxford 1995.
antigens ‘A’, ‘B’ and ‘D’ (Rh)
Anti-A 1 x 10 mL
Anti-B 1 x 10 mL
Anti-D(IgG+IgM) 1 x 10 mL
These reagents contain sodium azide (<0.1%), sodium arsenite (0.02%) and bovine
albumin.
STORAGE AND STABILITY
The sealed reagents are stable up to expiry date stated on the label when stored
at 2-80C. It is advisable to minimize its time outside the refrigerator between two uses.
SAMPLE
Blood collected with or without anticoagulant : EDTA, heparin or citrate,
stored beween 20C to 80C upto 48 hours. Haemolysed blood should not be used.
LABORATORY PROCEDURE
PLATE TECHNIQUE AT ROOM TEMPERATURE
Bring the reagents to room temperature. Place one drop of Anti-A,Anti -B & Anti D
reagent on a clean slide, and then add one small drop of whole blood. Mix well with a
mixing stick uniformly. Rock the slide gently back and forth for about 3 minutes while
macroscopically observing the possible appearance of agglutination.
DIRECT METHOD IN A TUBE AT ROOM TEMPERATURE
Prepare a 5% suspension of red blood cells in isotonic saline solution. Using the vial
dropper, place one drop of Anti-A,Anti -B & Anti D reagent in to labeled test tube.
Add a drop of 5 % RBC suspension. Shake to homogenize the mixture, then centrifuge
at 1000 RPM for 60 seconds. Read macroscopically for appearance of any
agglutination.
INTERPRETATION
With both the above methods, if there is agglutination (the red blood cells from one
or several clumps) the reaction is positive and the antigen or at least one of the
antigens corresponding to the reagent used is present on the red blood cells tested.

ADL/V.03/February 2013

81
 Blood GROUPING
3 x 10 mL
ANTI - A, B & D (IgM) 13601013
INTENDED USE
BIBLIOGRAPHY
This reagent is intended for in vitro determination of ABO group and Rh typing of
human red blood cell antigens. 1. Common Techanical Specifications (CTs) for the in vitro diagnosis medical devices
of annex II, list A, of directive 98/79/EC are notified in the official journal of the
Monoclonal antibody technology European communities under document No.C (2202) 1344, with EEA relevance
Highly specific (2202/364/CE)
Convenient slide and tube formats 2. Mannessier, .L ; Blood transfusion center Lille France. The use of monoclonal
antibodies as blood grouping reagents: applications, advantages and problems.
CLINICAL SIGNIFICANCE Congress of the Italian society for blood transfusion –Rome-June 1992.
The ABO grouping is defined by both, the presence of ‘A’ and/or ‘B’ antigens on the 3. Blood group serology, Boorman, Dodd and Lincoln, Churchill Livingstone, 6th
surface of the red blood cells, and by simultaneous presence of Anti-A and or Anti-B edition.
antibodies in the serum. An individual has in his serum the antibodies corresponding 4. Human blood groups, Geoff Daniels, 1st edition, Blackwell Science, Oxford 1995.
to the antigens which are not present on his red blood cells.
Based on the principle of hemagglutination, human red blood cells possessing ‘A’ and
/or ‘B’ antigen will agglutinate in the presence of corresponding antibody directed
towards the antigen.
Human red blood cells are classified as Rh positive (Rh+) or Rh negative (Rh-) depending
upon the presence or absence of ‘D’ antigen on them. Red blood cells possessing D
antigen will agglutinate in the presence of reagent containing corresponding antibody.
REAGENT COMPOSITION
Anti-A, Anti-B and Anti-D are ready to use reagents prepared from supernatents of
mouse hybridoma cell cultures. These antibodies of immunoglobin class IgM (Anti-D
IgM) are a mixture of several monoclonal antibodies of the same specificity but having
capacity of recognising different epitopes of human red blood cell antigens ‘A’, ‘B’ and
‘D’ (Rh)
Anti – A 1 x 10 mL
Anti – B 1 x 10 mL
Anti – D (IgM) 1 x 10 mL
These reagents contain sodium azide (<0.1%), sodium arsenite (0.02%) and bovine
albumin.
STORAGE AND STABILITY
The sealed reagents are stable up to expiry date stated on the label when stored at 2-
80C. It is advisable to minimize its time outside the refrigerator and to avoid leaving it
at room temperature between two uses.
SAMPLE
Blood collected with or without anticoagulant : EDTA, heparin or citrate, stored beween
20C to 80C upto 48 hours. Haemolysed blood should not be used.
LABORATORY PROCEDURE
Plate technique at room temperature
On a rigorously clean plate, using the vial dropper, apply one drop of each reagent.
Take one drop of blood and apply next to each drop of reagent, taking care not to
create contact between the drops. Mix the blood and reagent using a spiral movement
with the end of the stirrer so as to create a regular lozenge of diameter 2 to 3 cm.
Incubate the plate at room temperature and with out stirring for 30 seconds. Hold
the plate and give it a rolling movement for 3 minutes while macroscopically observing
the possible appearance of agglutinates. Read reaction immediately.
Direct method in a tube at room temperature
Prepare a 5% suspension of red blood cells in isotonic saline solution. Using the vial
dropper, transfer a drop reagent Anti-A, Anti-B and Anti-D into correspondingly labeled
tubes. Add a drop of red blood cell suspension. Shake to homogenize the mixture,
then centrifuge at 1000 rpm for 1 minutes. Read macroscopically while gently shaking
the tubes. Note the appearance of any agglutinates.
INTERPRETATION
With both the above methods, if there is agglutination (the red blood cells from one
or several clumps) the reaction is positive and the antigen or at least one of the
antigens corresponding to the reagent used is present on the red blood cells tested.
If there is no agglutination (red blood cells reform a homogenous suspension), the
reaction is negative and the antigen is not present on the red blood cells.
In case of anti D agglutination is a positive test indicates presence of Rh antigen i.e.
Rh positive. If there is no agglutination (i.e. clumbing is absent), it indicates either
presence of weaker varients of Rh antigens like Du or absence of Rh antigens. It is
possible to use Anti TOTEM in an andirect coomb’s test if weak / or partial antigens D
are to be detected.
Drying at the periphery or fibrin strands should not be misinterpreted as agglutination.

82
 Blood GROUPING
1 x 10 mL
ANTI - B 13601009
INTENDED USE
This reagent is a monoclonal antibody solution intended for determination of red cells
having B antigen on the surface, who are categorized as B group individuals.
- Monoclonal antibody technology
- High avidity and high titre
- Convenient pack sizes
PRINCIPLE
This technique employs the principle of hemagglutination. When the red blood cells
bearing the B antigens are mixed with the Anti-B solution, if agglutination occurs
indicates the presence of B antigen, and the individual belongs to B group and if no
agglutination occurs indicated absence of B antigen.
REAGENT COMPOSITION
Anti B is ready to use reagent prepared from supernatents of mouse hybridoma cell
culters. These reagents contain sodium azide (<0.1%), sodium arsenite (0.02%) and
bovine albumin.
STORAGE AND STABILITY
The sealed reagent is stable up to expiry date stated on the vial label, when stored at
2-80C. It is advisable to minimize its time outside the refrigerator between two uses.
SAMPLE
Whole blood sample must be examined with in 48 hrs. Samples should be stored at
2-80C, if not tested immediately. Do not use haemolysed samples.
LABORATORY PROCEDURE
PLATE TECHNIQUE AT ROOM TEMPERATURE
Bring the reagents to room temperature. Place one drop of Anti-B reagent on a clean
slide, and then add one small drop of whole blood. Mix well with a mixing stick
uniformly. Rock the slide gently back and forth for about 3 minutes while
macroscopically observing the possible appearance of agglutination.
DIRECT METHOD IN A TUBE AT ROOM TEMPERATURE
Prepare a 5% suspension of red blood cells in isotonic saline solution. Using the vial
dropper, place one drop of Anti-B reagent in to labeled test tube. Add a drop of 5%
RBC suspension. Shake to homogenize the mixture, then centrifuge at 1000 RPM for
60 seconds. Read macroscopically for appearance of any agglutination.
INTERPRETATION
If there is agglutination (ie clumping of red blood cells) the test result indicates the
presence of B antigen.
If there is no visible agglutination, (ie clumping is absent), the test result indicates the
absence of B antigen.
NOTE:
For getting high titre use ABD dilution buffer (code.13601330). The ABD dilution
buffer will be provided on request.
BIBLIOGRAPHY
1. Mannessier, L.; Blood transfusion center Lille France. The use of monoclonal
antibodies as blood grouping reagents: applications, advantages and problems.
Congress of the Italian society for blood transfusion –Rome-June 1992.
2. Blood group serology, Boorman, Dodd and Lincol Churchil Livingstone 6th edition.
3. Human blood groups, Geoff Daniela, 1st edition Blackwell Science, Oxford 1995.

ADL/V.03/February 2013

83
 Blood GROUPING
1 x 10 mL
ANTI - D (IgG+IgM) 13601003
INTENDED USE CLONAL SPECIFICITY OF ANTI D (IgG+IgM)
This reagent is intended for in vitro determination of presence or absence of Rho D
(D) antigen on human red blood cells. IIIa D D D D D D D HMi
- Monoclonal antibody technology D IIIb IVa IVb Va VI VII FR BT RoHor
- High avidity and high titre Clones Type II IIIc (RH33)
- Convenient pack sizes P3X61 IgM + + + + + - + +/- + + +
- Detects most variants of D antigen P3X212 IgM - + - - + + + + - - +
CLINICAL SIGNIFICANCE 23B10
Human erythrocytes having Rho Antigen (D-Ag) will cause agglutination is the P3X290 IgG + + +/- - + +/- + + - - +
presence of Anti-D. Antibodies present in the reagent Human red blood cells are P3X35 IgG + + + + - - + - - - +
classified as Rho(D) positive or Rho (D) negative depending upon the presence or The table gives the specificity of clones used in Anti D (IgG+IgM) reagent against
absence of D(Rho) antigen on them. All negative test results should be further variants D Antigen. The intensity of reactions obtained with Anti D (IgG+IgM) may
confirmed by coomb’s test. vary as a function of the number of antigen sites present on the test red blood cells.
REAGENT COMPOSITION BIBLIOGRAPHY
The Anti –D is a monoclonal blend (IgG+IgM) antibodies derived from the 1. Mannessier, L.; Blood transfusion center Lille France. The use of monoclonal
supernatant of Hybridomas of murine (or) human origin. These reagents contain antibodies as blood grouping reagents: applications, advantages and problems.
sodium azide (<0.1%) sodium arsenite (0.02%) and bovine albumin. Congress of the Italian society for blood transfusion –Rome-June 1992.
STORAGE AND STABILITY 2. Blood group serology, Boorman, Dodd and Lincoln, Churchill Livingstone, 6th
edition.
The sealed reagents are stable up to expiry date stated on the label when stored 3. Human blood groups, Geoff Daniels, 1st edition, Blackwell Science, Oxford 1995.
at 2-80C. It is advisable to minimize its time outside the refrigerator and to avoid
leaving it at room temperature between two uses.
SAMPLE
Whole blood samples must be examined within 48 hrs. Samples should be stored
at 2-80C, if not tested immediately. Do not use haemolysed samples.
LABORATORY PROCEDURE
A) PLATE TECHNIQUE AT ROOM TEMPERATURE
Bring the reagents to room temperature. Place one drop of Anti-D (IgG+IgM) reagent
on a clean slide, then add one small drop of whole blood. Mix well with a mixing
stick uniformly. Rock the slide gently back and forth for about 3 minutes while
macroscopically observing the possible appearance of agglutinates.
B) DIRECT METHOD IN A TUBE AT ROOM TEMPERATURE
Prepare a 5% suspension of red blood cells in isotonic saline solution. Using the
vial dropper, transfer a drop reagent Anti- D(IgG+IgM)reagent in to a labelled test
tube. Add a drop of red blood cell suspension. Shake to homogenize the mixture,
then centrifuge at 1000 rpm for one minute. Read macroscopically while gently
shaking the tubes so as to detach the RBC pellets. Note the appearance of any
agglutinates.
INTERPRETATION
If there is agglutination (i.e. clumping red blood cells) while using direct
hemagglutination method on a plate or in a tube, the test result indicates the
presence of D antigen (Rh positive)
If there is no agglutination, while using direct hemagglutination method on a plate
or in a tube, the test result indicates the absence of D antigen (Rh negative)
The presence or absence of weak and / or partial D antigen, should be confirmed
by carrying out Indirect Antiglobulin Test (IAT)

Drying at the periphery or fibrin strands should not be misinterpreted as

agglutination.
NOTES
1. The reactions must be read immediately after centrifuging and re-suspending.
2. Anti D (IgG+IgM) have the special feature of recognizing certain rare antigen
motives of type RH33 (RoHar) and may thus yield discordant reactions with
polyclonal reagents that recognize them little or not at all.
3. For specific identification of partial D antigen, the use of any 3rd party kit for
this purpose is recommended.
4. A false positive reaction may occur if the subject tested has cold agglutinatinins
5. Anti D (IgG+IgM) cannot ensure the recognition of all weak or variant subjects,
due to the variability of antigen motifs.
6. Certain discordances (negative reaction for the direct hemagglutination method
and positive reaction for the indirect antiglobulin method) may occur with Anti
D (IgG+IgM). A weak and/or partial D antigen may be suspected.
7. A false –positive reaction may occur, when Anti D (IgG+IgM) is used in the
indirect antiglobulin method (IAT), if the RBC from the test subject shows a
positive reaction in the direct antiglobulin test (DAT)
8. A negative reaction obtained in an indirect antiglobulin test can be validated
with IgG-sensitized red blood cells (not provided with this kit)
9. For getting high titre use ABD dilution buffer (code.13601330) . The ABD dilution
buffer will be provided on request.

ADL/V.02/February 2013

84
 Blood GROUPING
1 x 10 mL
ANTI - D (IgM) 13601015
INTENDED USE
This reagent is intended for in vitro determination of presence or absence of Rho (D)
antigen on human red blood cells.
- Monoclonal IgM Antibodies
- High avidity and high titre
- Convenient pack sizes
PRINCIPLE
The test procedure recommended for the use of this antisera are based upon the
agglutination (clumping) of red blood cells carrying the D antigen in the presence of
an IgM Anti-D antibody. All negative test results should be further confirmed by Du
test.
REAGENT COMPOSITION
The reagents contain monoclonal antibodies. The monoclonal antibodies are derived
from the supernantants of in vitro cultures of hybridomas of murine origin. These
reagents contain sodium azide (<0.1%) sodium arsenite (0.02%) and bovine albumin.
STORAGE AND STABILITY
The reagents must be stored between +2oC and +80C. It is advisable to minimize its
time outside the refrigerator and to avoid leaving it at room temperature between two
uses.
SAMPLE
Blood collected in anticoagulant : EDTA, heparin or citrated in a stoppered sterile tube,
stored between 2-80C. At the time of the test, centrifuge the blood sample at 1200 g
for 3 minutes. Do not use hemolysed samples
LABORATORY PROCEDURE
A) PLATE TECHNIQUE AT ROOM TEMPERATURE
Bring the reagents to room temperature. Place one drop of Anti-D (IgM) reagent on a
clean slide, then add one small drop of whole blood. Mix well with a mixing stick
uniformly. Rock the slide gently back and forth for about 3 minutes while
macroscopically observing the possible appearance of agglutination.
B) DIRECT METHOD IN A TUBE AT ROOM TEMPERATURE
Prepare a 5% suspension of red blood cells in isotonic saline solution. Using the vial
dropper, transfer a drop reagent Anti- D(IgM)reagent in to a labelled test tube. Add a
drop of red blood cell suspension. Shake to homogenize the mixture, then centrifuge
at 1000 rpm for one minute. Read macroscopically while gently shaking the tubes so
as to detach the RBC pellets. Note the appearance of any agglutination.
INTERPRETATION
If there is agglutination (ie, clumping red blood cells) with Anti-D(IgM) antigen D is
present.
If there is no agglutination (ie, clumping is absent) it is possible to use Anti D (IgG)
in a coomb’s test to rule out the presence of weak and partial D antigens.
NOTES
1. The reactions must be read immediately after centrifuging and resuspending.
2. A false positive reaction may occur if the subject tested has cold agglutinins.
3. Anti D (IgM) cannot ensure the recognition of weak or variant subjects, due to
the variability of antigen motifs.
4. For getting high titre use ABD dilution buffer (code.13601330) . The ABD dilution
buffer will be provided on request.
BIBLIOGRAPHY
1. Betermieux, C., Beolet, M. , Keyser, L.; A new strategy for D phenotyping with
TOTEM multimonoclonal ANTI –D reagent, XX111rd I.S.B.T. Congress, July 1994.
2. Aramburu, E., Rabasa, P. , Esquiroz, R., Galarretat, B. Valoracion de un antisureo
anti-D IgM-IgG monoclonal (DIAGAST) en donantes de sangre concentration
expresividaddedli del anti geno. Hematology congress, Madrid, October 1990.
3. Mannessier, L. Blood transfusion center, Lille, France. The use of monoclonal
antibodies as blood grouping reagents: applications, advantages and problems.
Congress of the Italian society for blood transfusion ,Rome,June 199

85
 2 x 4 mL
PT (S.L) 12601003
INTENDED USE Mix gently, 9 parts of blood in a plastic tube or siliconized glass tube containing 1
This reagent is intended for the in vitro determination of Prothrombin Time in citrated part of 3.2% tri sodium citrate solution (0.109 M). Centrifuge immediately for 15
plasma. min at 3000 rpm to obtain platelet poor plasma. Transfer supernatant plasma in a
siliconized glass tube or plastic tube immediately, do not disturb buffy coat while
CLINICAL SIGNIFICANCE collecting supernatant plasma. For best results the test should be done within 2
The Prothrombin Time is an indicator of the extrinsic blood coagulation mechanism. hours of blood collection.
Deficiencies of Prothrombin and co factors V, VII and X give rise to a prolonged
clotting time. TEST PROCEDURE
Presence of high levels of Heparin in the blood sample hypofibrinogenemia also The PT for each sample should be determined at least twice. This procedure pertains
attribute for prolonged time. to manual or semi-automated coagulation systems. Refer to your instrument
manual for more detailed instrument specific instruction.
Common causes prolonged one stage prothrombin time are:
1. Therapy with coumarin or indanedione drugs. Manual Method
2. Obstructive jaundice 1. Gently swirl the reagent vials before use. Do not shake.
3. Hemorrhagic disease of the new born 2. Dispense from the vial enough PT Reagent for immediate use, into a thoroughly
4. Liver disease. clean dry test tube.
Less common causes: 3. Pre-warm the dispensed PT Reagent to 370C for 10 minutes.
1. Heparin therapy 4. Pipette 100 µL of plasma into test cuvette at 37 0 C, and incubate for
2. Loss of clotting proteins from blood via kidneys in renal disease. 3 minutes.
Eg. Nephrotic syndrome 5. Add forcibly 200 µL pre-warmed PT reagent into the test cuvette.
3. Congenital deficiency of clotting factor(s) 6. Start timer simultaneously and record the clotting time in seconds.
4. Fibrinogen deficiency CALCULATION
5. Vitamin K deficiency
The ISI as well as nature of preparation varies worldwide, it is recommended to
PRINCIPLE express results of the coagulation assays in terms of INR and this can be derived
Tissue thromboplastin in the presence of Ca++ activates extrinsic pathway of human from the accompanying INR conversion table or calculated from the below
blood coagulation cascade. Activation time is proportional to the concentration of mentioned relationship
individual clotting factors taking part in the coagulation cascade. This assists in (International Normalized Ratio) INR = RISI where,
estimating cause and extent of haemorrhagic disorder. Mean PT of the patients plasma in sec
When thromboplastin reagent is added to citrated plasma, clotting cascade is R(prothrombin ratio) = -----------------------------------------------------
initiated forming gel clot. The time required for clot formation would be prolonged
if there is deficiency of factor (s) activity in the extrinsic pathway of the coagulation MNPT (Mean Normal PT) for the reagent
cycle. MNPT: Each laboratory must establish its own MNPT for each lot of reagent and
instrument used. Usually plasma from at least 20 normal healthy individual should
REAGENT COMPOSITION be used to establish the MNPT. ISI value of the reagent is mentioned on the vial
PROTHROMBIN TIME (PT) label.
TF (Rabbit origin) PRECAUTION
Ca++ Venous blood should be directly drawn into the tube containing anticoagulant.
Antimicrobials Ensure that the sample is free of microclots.
Stabilizers Separate plasma immediately by centrifugation after collection of blood.
PACK CONTENTS The test should be done within two hours of blood collection.
PT Reagent 2 x 4 mL Plasma must be stored in siliconized glass tubes or plastic containers.
Buffered tri sodium citrate (0.109M) 3.2% 1 x 10 mL Avoid turbid, lipemic or hemolyzed samples.
Use clean dry micropipette tips and plasticware to dispense the reagent.
STORAGE AND STABILITY
Close reagent vial and replace immediately to 2-80C after dispensing.
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2-80C. GUARANTEE
Do not freeze. This product is guaranteed to perform as described on label and package insert.
The manufacturer disclaims any warranty of use and sale for any other purpose.
NORMAL RANGE
Clotting time : 10 - 15 sec BIBLIOGRAPHY
Prothrombin ratio : 1 ± 0.15 (depends on methodology) 1. Dacie, J.V., Lewis, S.M.; Practical hematology. 1984
INR value : 0.8 -1.5 2. R Biggs, R, Mcfarlane, R. G; Human blood coagulation and its disorders 1963
3. Burtis, et al. Tietz: Text book of Clinical Chemistry AACC 1999
The clotting time of abnormal plasma will depend on the International Sensitivity 4. Roadck, B. F.; Diagnostic Hematology, clinical principles and applications 2nd
Index (ISI) of the reagent lot. Normal range should be established in the user’s edition.
laboratory. 5. John Bernad Henry: Clinical Diagnosis and management by laboratory methods
SAMPLE COLLECTION PREPARATION 20th edition.
Citrated plasma. 6. Data on file of Agappe Diagnostics Ltd. Kerala.

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86
 2 x 4 mL
APTT 12602001
INTENDED USE Bring contents of the vial to room temperature and then swirl gently to mix to a
This reagent is intended for the in vitro determination of Activated Partial homogenized suspension. Keep the reagents at 370C for 10 minutes prior to use.
Thromboplastin Time (APTT) in citrated plasma. 1. Gently swirl the reagent vials before use. Do not shake.
2. Pre-warm enough volume of Reagent1 (CaCl2) for immediate use, in a clean & dry
CLINICAL SIGNIFICANCE plastic test tube at 370C.
The activated partial thromboplastin time (APTT) is used as a general screening test 3. Pipette 100 µL of test plasma or control in to a test cuvette at 370C.
for the detection of coagulation abnormalities in the intrinsic pathway. APTT is sensitive 4. Pipette 100 µL of the pre-warmed reagent 2 (APTT Reagent) in to the test cuvette.
to deficiencies or abnormalities of factors VIII, IX, XI, XII, X, V, II and I. APTT is also 5. Mix well and incubate at 370C for 3 minutes.
sensitive to inhibitors of blood coagulation such as lupus inhibitor and fibrin/ 6. Forcibly pipette 100 µL of pre warmed Reagent1 (CaCl2) into the test cuvette.
fibrinogen degradation products. APTT is the most widely used method for monitoring 7. Start a timer simultaneously and record the clotting time in seconds.
intravenous heparin anticoagulation therapy. Calibration curve for the determination of Heparin concentration:
PRINCIPLE Dilute Heparin (as used for treatment) with physiological saline to concentration of
In presence of Calcium ions cephaloplastin activates coagulation factors of intrinsic 10 IU/mL.
pathway in plasma leading to clot formation. Clotting time is proportional to the Mix 0.2 mL of 10 IU/mL diluted heparin with 1.8 mL of FNP (Fresh Normal Plasma) to
concentration of factors VIII, IX, XI and XII as well as common pathway factors II, V, yield heparin standard of 1 IU/mL concentration.
and X. As the reagent is prepared using one single species rabbit brain, it has the Dilute the Heparin standard as prepared above (1 IU/ml) with FNP as follows.
required sensitivity to be used in heparin assays, also has better sensitivity for factors Test Tube 1 2 3 4 5 6 7
VIII & LA. Heparin std.(1IU/mL) 0.5 0.4 0.3 0.2 0.1 0.1 -
PACK CONTENTS FNP in mL - 0.1 0.2 0.3 0.4 0.9 0.5
APTT Reagent 1 2 x 4 mL Heparin con.(IU/mL) 1 0.8 0.6 0.4 0.2 0.1 0
Calcium chloride solution 0.020 M/L Procedure: Manual method to estimate Heparin concentration in the plasma/sample.
. Pipette 0.1mL of each Heparin dilution into clean test tubes.
APTT Reagent 2 2 x 4 mL . Add 0.1 mL APTT Reagent (pre-warmed at 370C). Mix and incubate for exactly
Rabbit brain cephalin 3 minutes at 370C.
Ellagic acid activator . Add. 0.1 mL Pre-warmed Calcium chloride (0.0290 M/L) and simultaneously start
Buffer stopwatch.
. Observe clot formation carefully and note the time at the appearance of first
Stabilizers and preservatives fibrin web.
Tri sodium citrate (0.109 M/L) 3.2% 1 x 10 mL . Plot mean of double determination in seconds against each heparin
STORAGE AND STABILITY concentration on heparin calibration graph paper provided.
. Connect points in a straight line.
The sealed reagents are stable up to the expiry date stated on the label, when stored *Plot clotting time of sample on the calibration curve and read heparin
at 2-80C. concentration in IU/mL
Do not freeze. Note: Laboratories using coagulometers should follow instructions (sequence) of
NORMAL RANGE the coagulometer manufacturer.
The normal values are between 21-38 seconds (at 3 minutes activation). The normal Warranty: The product is designed to perform as described in the pack insert. The
time depends on the method, activation time, instrument etc. and must be determined manufacturer disclaims any implied warranty of use and sale for any other purpose.
in each laboratory. CALCULATION
PRECAUTION The result of APTT test can be reported directly in seconds.
Venous blood should be directly drawn into the tube containing anticoagulant. BIBLIOGRAPHY
Ensure that the sample is free of microclots. 1. Dacie, J.V., Lewis, S.M.; Practical hematology. 1984
Separate plasma immediately by centrifugation after collection of blood. 2. R Biggs, R, Mcfarlane, R. G; Human blood coagulation and its disorders 1963
The test should be done preferably within two hours of blood collection. 3. Burtis, et al. Tietz: Text book of Clinical Chemistry AACC 1999
Plasma must be stored in siliconized glass tubes or plastic containers. 4. Roadck, B. F; Diagnostic Hematology, clinical principles and applications 2nd
Avoid turbid, lipemic or hemolyzed samples. edition.
5. John Bernad Henry: Clinical Diagnosis and management by laboratory methods
Use clean dry micropipette tips and plasticware to dispense the reagent. 20th edition.
Mix the reagent (by gentle swirling) before use. 6. Data on file of Agappe Diagnostics Ltd. Kerala.
Close reagent vial and replace immediately to 2-80C after dispensing.
SAMPLE COLLECTION & PREPARATION
Citrated plasma.
Mix gently, 9 parts of blood in a plastic tube or siliconzied glass tube containing 1
part of 3.2% tri-sodium citrate solution (0.109 M/L). Centrifuge immediately for 15
minutes at 3000 rpm to obtain platelet poor plasma. Transfer supernatant plasma in
a siliconized glass tube or plastic tube immediately; do not disturb the buffy coat while
collecting supernatant plasma. The test should be done preferably within 2 hours of
blood collection.
TEST PROCEDURE
APTT of each sample should be determined at each level twice. This procedure pertains
to manual or semi-automated coagulation systems. Refer to your instrument manual
for more detailed instrument specific instructions

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 Haemo CHEK
1 x 10 Litre, 1 x 20 Litre
DILUENT 14001001, 14001002
INTENDED USE
Diluent is intended for counting and sizing of blood cells in MINDRAY- 3 part
Differential Hematology Analyzers of BC Series. It is an azide free filtered isotonic
solution.
REAGENT COMPOSITION
Sodium chloride 3 - 5.5 g/L
Sodium sulphate anhydrous 7.5 - 11.5g/L
Buffering agents 1- 3 g/L
Anti fungal & anti bacterial Agent 0.8 - 2.5 g/L
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 150C to 300C.
ONCE OPENED STABLE FOR 60 DAYS.
DIRECTIONS FOR USE
Follow the procedures given in the operation manual of Mindray 3 part differential
Hematology Analyzer.
PRECAUTIONS AND WARNING
1. For in vitro diagnostic use only.
2. Do not pipette by mouth.
3. Do not inhale the reagent.
4. If the reagent comes in contact with, eye or skin wash off immediately with large
quantity of water and seek medical attention immediately
5. Do not use the reagent in any procedures other than those described herein
6. Do not use containers and other materials in the package for any purpose other
than those described herein
7. When discarding the reagents dispose of them according to local regulations.
8. Take normal precautions required for handling laboratory reagents.

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 Haemo CHEK
4 x 50 mL
E-Z CLEANER 14002001
INTENDED USE
EZ cleaner is intended for daily cleaning of MINDRAY- 3 part Differential Hematology
Analyzers of BC Series.
REAGENT COMPOSITION
Proteolytic enzyme 3.0 - 10 g/L
Substrate 0.3 - 1.5 g/L
Sodium chloride 3.0 - 5.0 g/L
Buffering agents 1.0 - 4.0 g/L
Anti fungal & anti bacterial agent 0.5 -2.5 g/L
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 150C to 300C.
Discard the reagent if kept opened for more than 30 days.
DIRECTIONS FOR USE
Follow the procedures given in the operation manual of Mindray 3 part differential
hematology analyzer.
PRECAUTIONS AND WARNING
1. For in vitro diagnostic use only.
2. Do not pipette by mouth.
3. Do not inhale the reagent.
4. If the reagent comes in contact with eye or skin, wash off immediately with large
amount of water and seek medical attention immediately
5. Do not use the reagent described above in any procedures other than those
described herein.
6. Do not use containers and other materials in the package for any purpose other
than those described herein.
7. When discarding the reagents dispose of them according to local regulations.
8. Attend to the normal precautions required for handling all laboratory reagents.

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 Haemo CHEK
1x500 mL/2x500 mL
LYSE 14003001/14003002
INTENDED USE
Lyse is intended for lysing of cells for WBC Count and Hemoglobin measurement
in MINDRAY-3 part Differential Hematology Analyzers of BC Series.
REAGENT COMPOSITION
Quaternary ammonium salts - < 50 g/L
Non-ionic surfactant - < 15 g/L
2-Propanol - 0.1 - 1.5mL/L
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 150C to 300C.
ONCE OPENED STABLE FOR 60 DAYS
DIRECTIONS FOR USE
Follow the procedures given in the operation manual of Mindray 3 part differential
hematology analyzer.
PRECAUTIONS AND WARNING
1. For in vitro diagnostic use only.
2. Do not pipette by mouth.
3. Do not inhale the reagent
4. If the reagent comes in contact with eye or skin, wash off immediately with large
quantity of water and seek medical attention immediately
5. Do not use the reagent described above in any procedures other than those
described herein.
6. Do not use containers and other materials in the package for any purpose other
than those described herein.
7. When discarding the reagents dispose of them according to local regulations.
8. Attend to the normal precautions required for handling all laboratory reagents.

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 Haemo CHEK
4 x 50 mL
PROBE CLEANER 14004001
INTENDED USE
Probe cleaner is intended for periodical cleaning of sample probe inMINDRAY-3 part
Differential Hematology Analyzers of BC Series.
REAGENT COMPOSITION
Surfactant > 2.0 g/L
Sodium hypochlorite > 100 g/L
Sodium chloride > 100 g/L
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 150C to 300C.
DIRECTIONS FOR USE
Follow the procedures given in the operation manual of Mindray 3 part differential
Hematology Analyzer.
PRECAUTIONS AND WARNING
1. For in vitro diagnostic use only.
2. Do not pipette by mouth.
3. Do not inhale the reagent.
4. If the reagent comes in contact with eye or skin, wash off immediately with large
amount of water and seek medical attention immediately
5. Do not use the reagent described above in any procedures other than those
described here in.
6. Do not use containers and other materials in the package for any purpose other
than those described here in.
7. When discarding the reagents dispose of them according to local regulations
8. Attend to the normal precautions required for handling all laboratory reagents.

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 Haemo CHEK
1 x 10 Litre, 1 x 20 Litre
RINSE 14005001, 14005002
INTENDED USE
Rinse is intended for cleaning the volumetric tubes of MINDRAY-3 part Differential
Hematology Analyzers of BC Series.
It is an azide free filtered solution.
REAGENT COMPOSITION
Sodium chloride 3.0 - 5.5 g/L
Sodium sulphate anhydrous 7.5 - 11.5 g/L
Buffering agents 1.0 - 3.0 g/L
Non ionic surfactant 5.0 - 8.0 g/L
Anti fungal & anti bacterial agent 0.8 - 2.5 g/L
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 150C to 300C.
ONCE OPENED THE REAGENT IS STABLE FOR 60 DAYS
DIRECTIONS FOR USE
Follow the procedures given in the operation manual of Mindray 3 part differential
Hematology Analyzer.
PRECAUTIONS AND WARNING
1. For in vitro diagnostic use only.
2. Do not pipette by mouth.
3. Do not inhale the reagent.
4. If the reagent comes in contact with eye or skin, wash off immediately with large
quantity of water and seek medical attention immediately.
5. Do not use the reagent described above in any procedures other than those
described here in.
6. Do not use containers and other materials in the package for any purpose
other than those described here in.
7. When discarding the reagents dispose of them according to local regulations.
8. Attend to the normal precautions required for handling all laboratory reagents.

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 1 x 1 mL
ASO CALIBRATOR 11615003
INTENDED USE
This reagent is intended for the preparation of calibration curve for ASO estimation.
REAGENT COMPOSITION
ASO calibrator is prepared by diluting human plasma which contains high levels of
Anti Streptolysin – O (ASO) with physiological saline containing 1%(w/v) bovine
serum albumin.
STORAGE AND STABILITY
The sealed vials are stable up to expiry date if kept at 2-80C, protected from light.
PREPARATION AND STABILITY OF CALIBRATOR
Calibrator is ready to use and concentration is mentioned on the vial.
PRECAUTION
To avoid contamination, use clean laboratory wares. Close the vials immediately
after use. Protect from light and heat. Improper handling or storage of the
calibrators can affect results.
WARNING
Human source material. Each donor unit although tested negative for HbsAg, HCV,
HIV(1&2) treat as potentially infectious material
Reagents containing sodium azide must be handled with care.
BIBLIOGRAPHY
1. Galuin, J.Pet al., Particle enhanced photometric immunoaasay system
2. Singer, J. M.et al., The latex fixation test Application to the serologic diagnosis
of rheumatoid arthritis, Amer. J. med., 21, 888(1956)

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93
 1 x 1 mL
MICROALBUMIN CALIBRATOR 11618003
INTENDED USE
This reagent is intended for the preparation of calibration curve for microalbumin
estimation.
REAGENT COMPOSITION
A dilution of defibrinated human albumin solution with phosphate buffered saline,
liquid stabilized filtered through 0.2m filter.
Sodium azide – 0.095%
STORAGE AND STABILITY
The sealed vials are stable up to expiry date at 2-80C, protected from light.
PREPARATION AND STABILITY OF CALIBRATOR
Calibrator is stable liquid and the concentration will be mentioned on the vial.
Generate a calibration curve by diluting the calibrator as follows:
Preparation of calibration curve:
Prepare the following calibrator dilution using NaCI as diluent. Multiply the
concentration of the microalbumin calibrator by the corresponding factors stated in
the table below to obtain the microalbumin concentration of each dilution.
Dilution 1 2 3 4 5 6
Cali. (µL) - 10 10 25 50 100
Saline (µL) 100 150 70 75 50 -
Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
Opened vials are stable up to 6 weeks when stored at 2-8 0C.
PRECAUTION
To avoid contamination, use clean laboratory wares. Close the vials immediately
after use. Protect from light and heat. Improper handling or storage of the
calibrators can affect results.
WARNING
Human source material. Each plasma donor unit although tested negative for HbsAg,
HCV, HIV(1&2) treat as potentially infectious material.
Reagents containing sodium azide must be handled with care.
BIBLIOGRAPHY
Mount, N.J. Clin, Pathology, 22, 12(1986)

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 1 x 2 mL
CRP CALIBRATOR 11616001
INTENDED USE
This reagent is intended for the preparation of calibration curve for CRP estimation.
REAGENT COMPOSITION
CRP calibrator is prepared by diluting defibrinated human plasma with phosphate
buffered saline.
STORAGE AND STABILITY
The sealed vials are stable up to expiry date when kept at 2-80C, protected from light.
PREPARATION AND STABILITY OF CALIBRATOR
Calibrator is stable liquid and concentration will be mentioned on the vial. Generate a
calibration curve by diluting the calibrator serially.
Preparation of calibration Curve:
Prepare the following calibrator dilution using NaCI as diluent. Multiply the
concentration of the CRP calibrator by the corresponding factors stated in the table
below to obtain the CRP concentration of each dilution.
Dilution 1 2 3 4 5 6
Calib.(µL) - 10 10 20 50 100
Saline(µL) 100 150 70 60 50 -
Dil. Factor 0 0.0625 0.125 0.25 0.5 1.0

PRECAUTION
To avoid contamination, use clean laboratory wares. Close the vials immediately after
use. Protect from light and heat. Improper handling or storage of the calibrators can
affect results.
WARNING
Human source material. Each donor unit although tested negative for HbsAg, HCV,
HIV(1&2) treat as potentially infectious material.
Reagents containing sodium azide must be handled with care.
BIBLIOGRAPHY
1. Tillett. W.et al: Serological reactions in pneumonia with a non-protein somatic
fraction of pneumoccous.J. exp. Med.. 52,561(1930)
2. Ziegenhagen G,. Drahovshy D. Klimishe Bedeutung desc-Reakriven protein. Med
Klin 1983; 78:45-50

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95
 1 x 1 mL
Lp(a) CALIBRATOR 11619001
INTENDED USE
This reagent is intended for the preparation of calibration curve for Lp(a) estimation.
REAGENT COMPOSITION
Lyophilized human serum.
STORAGE AND STABILITY
The sealed vials are stable up to the expiry date at 2-80C, protected from light.
PREPARATION AND STABILITY OF CALIBRATOR
Remove the vial cap carefully and add exactly 1.0 mL of deionized water. After leaving
it for more than 10 minutes, shake it gently until the content is completely dissolved.
The reconstituted calibrator is stable for 7 days at 2-80C when protected from light
and heat.
PREPARATION OF CALIBRATION CURVE

Prepare the following calibrator dilution using NaCI as diluent. Multiply the
concentration of the Lp(a) calibrator by the corresponding factors stated in the table
below to obtain the Lp(a) concentration of each dilution.
Dilution 1 2 3 4 5 6
Calib.(µL) - 10 10 25 50 100
Saline(µL) 100 150 70 75 50 -
Dil. Factor 0 0.0625 0.125 0.25 0.5 1.0

PRECAUTION
To avoid contamination, use clean laboratory wares. Close the vials immediately after
use. Protect from light and heat. Improper handling or storage of the calibrators can
affect results.
WARNING
Human source material. Each plasma donor unit although tested negative for HbsAg,
HCV, HIV(1&2) treat as potentially infectious material.
BIBLIOGRAPHY
1. Utermann, G.et al. Lp(a) Glycoprotein phenotypes. Inheritance and
relation to Lp(a) Lipoprotein concentration in plasma.
2. J.Clin Invest., 80, 458(1987) MClea, J. W.et al. C DNA sequence of
human apo lipoprotein (a) is homologous, nature, 300, 132(1987)

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96
 1 x 1 mL
PROTEIN MULTICALIBRATOR 11614004
INTENDED USE
This reagent is intended for the preparation of reference curves for quantitative
immunochemical determination of protein in human serum.
REAGENT COMPOSITION
Protein multicalibrator is a defibrinated human plasma, liquid stabilized and filtered
through 0.2 m filter.
Sodium azide – 0.05%
STORAGE AND STABILITY
The sealed vials are stable up to expiry date at 2-80C, if protected from light.
PREPARATION AND STABILITY OF CALIBRATOR
This protein multicalibrator should be treated similar to sample/control and the test
needs to be performed as per the procedure of the respective reagent.
Opened vials are stable up to 6 weeks when stored at 2-8 0C.
PRECAUTION
To avoid contamination, use clean laboratory wares. Close the vials immediately
after use. Protect from light and heat. Improper handling or storage of the
calibrators can affect results.
WARNING
Human source material. Each plasma donor unit although tested negative for HbsAg,
HCV, HIV(1&2) treat as potentially infectious material.
Reagents containing sodium azide must be handled with care.
BIBLIOGRAPHY
1. Dati, F. et al. Med. 13,87 (1889)
2. Poulik, M.D. and klesis in The plasma proteinso, vol.2 second
edition.F.W. Putman Acedemic press, New York, PP 52-108

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97
 5 x 3 mL
MULTICALIBRATOR 11610001
INTENDED USE ASSIGNED VALUES AND TRACEABILITY
Multicalibrator is a calibration serum intended for calibration of clinical chemistry The assigned values were determined using the methods mentioned in the value
assays suitable for manual procedure and automated analyzers. sheet. Determinations were performed under standardized conditions on
automated analyzers using Agappe reagents and Master Calibrator (SRM/NIST where
DESCRIPTION ever applicable).
Multicalibrator is lypholized calibrator based on human serum. The concentration The calibrator value specified is the median of all values obtained from separate
and activities of calibrator components have been chosen so as to ensure optimum participating laboratories in several independent series. Multicalibrator values are
calibration of automated analyzers. The chemical and biological components traceable to reference materials (SRM/NIST) where applicable.
included in this product were chosen to act in the serum matrix in a similar manner
to the corresponding components found in human serum. PRECAUTIONS AND WARNING
REAGENT COMPOSITION 1. For in vitro diagnostic use only
2. Do not pipette by mouth
Multicalibrator 5 x 3mL 3. If the multicalibrator comes in contact with, eye or skin, immediately wash off
Lyophilized human serum with additives with large quantity of water, and seek medical attention immediately.
Bacteriostatic agents and stabilizers. 4. Do not use containers and other materials in the package for any purpose other
(The concentration/activities of each calibrator components are Lot Specific. Please than those described herein.
refer to the attached value sheet). 5. When discarding the reagents dispose of them according to local regulations
6. Attend to the normal precautions required for handling laboratory reagents.
PREPARATION 7. All human material should be considered potentially infectious. All products
1. Carefully open one multicalibrator vial. derived from human blood are prepared exclusively from the blood of donors
2. Remove the cap and carefully lift the rubber stopper without removing it tested individually and shown to be free from HBsAg and antibodies to HCV
completely, allowing air to enter the vial through the groove of the lower part and HIV. The testing methods applied were FDA-approved or cleared in
of the stopper. compliance with the European Directve 98/79/EC, Annex II, List A. However, as
3. Remove the rubber stopper, avoiding any loss of the lyophilized material. no testing is absolute, the material should be treated just as carefully as patient
4. Carefully pipette exactly the same amount of deionized water as mentioned specimen.
on the vial label, into the opened vial 8. Do not use multicalibrator over the expiration date/stability period.
5. Replace the rubber stopper carefully. 9. MSDS is available upon request
6. Dissolve the contents completely by occasional gentle swirling (within 30 10. Use clean and dry micropipette tips and glassware to dispense multicalibrator.
minutes) (avoiding froth formation). DO NOT SHAKE NOTES
7. Let it stand at room temperature and away from light for 10 minutes.
8. Lyophilizate should be completely dissolved before use. 1. Bacterial contamination of the reconstituted multicalibrator will cause
reductions in the stability of many components.(Criterion for the stability is;
STORAGE AND STABILITY recovery within ±5% of initial value)
Store at 2-8oC, away from light. Unopened vial is stable until expiry date stated on 2. Bilirubin and Acid phosphatase are light sensitive.
the vial label. 3. Creatinine Kinase is sensitive to light and temperature.
Store the reconstituted calibrator vial tightly capped and protected from light when 4. For alkaline phosphate assay, allow the reconstituted multicalibrator to stand
not in use. for one hour at room temperature
The components of the reconstituted calibrator is stable for, 5. Inaccurate reconstitution and errors in assay technique can cause improper
calibration.
At least 8 hours at 15-250C 6. Excessive turbidity may indicate microbial contamination in which case the vial
At least 2 days at 2-80C should not be used.
At least 30 days at -20oC. BIBLIOGRAPHY
Aliquot and freeze once only. 1. Directive 2000/54/EC. Official Journal of the European Communities No. L262
Bilirubin in the reconstituted calibrator (when stored in dark) is stable for; October 17,2000
At least 3 hrs at 15-250C 2. ISO/DIS 17511. In vitro Diagnostic Medical Devises origin-Metrological
At least 8 hours at 2-80C Traceability of values assigned to calibrators and control materials. Geneva,
At least 14 days at -20oC. International Organization for standardization 2000.
3. SRM for clinical Chemistry of the National Institute of Standards & Technology
Aliquot and freeze once only. (NIST), Gaithersburg, Maryland, USA.
Acid phosphate in the reconstituted calibrator (when stored in dark) is stable for;
At least 4 hours 15-250C
At least 1 day at 2-80C
DIRECTIONS FOR USE
Multicalibrator is to be used in accordance with the directions accompanying the
reagents or kits referring to the same method, and following the technical data
sheet of the reagent in use. While following these directions, multicalibrator has
to be handled as patient serum.

ADL/V.01/APR 2012

98
 1 x 1 mL
FERRITIN CALIBRATOR 11620003
INTENDED USE
This reagent is intended for the preparation of calibration curve for Ferritin.
REAGENT COMPOSITION
Ferritin calibrator is prepared by diluting human plasma with phosphate buffered
saline.
STORAGE AND STABILITY
The sealed vials are stable up to expiry date at 2-80C, protected from light.
PREPARATION AND STABILITY OF CALIBRATOR
Ferritin calibrator is available in liquid form. Concentration will be mentioned on
the vials. Opened vials are stable for 4 weeks when stored at 2-8 0C.
PREPARATION OF CALIBRATION CURVE
Prepare the following calibrator dilution using NaCI as diluent. Multiply the
concentration of the ferritin calibrator by the corresponding factors stated in the table
below to obtain the ferritin concentration of each dilution.
Dilution 1 2 3 4 5 6
Calib.(µL) - 10 10 25 50 100
Saline(µL) 100 150 70 75 50 -
Dil. Factor 0 0.0625 0.125 0.25 0.5 1.0

PRECAUTION
To avoid contamination, use clean laboratory wares. Close the vials immediately
after use. Protect from light and heat. Improper handling or storage of the
calibrators can affect results.
WARNING
Human source material. Each donor unit although tested negative for HbsAg, HCV,
HIV(1&2) treat as potentially infectious material.
Reagents containing sodium azide must be handled with care.
BIBLIOGRAPHY
1. Cook, J.D., Lipschitz, D.A. Laughton, M.B.B., Miles, E.M. & Finch, C.A. Serum
ferritin as a measure of iron stores in normal subjects. A.M.J.clin Nutr 27:680-
1974
2. Walters, G.O. Miller, F.M & Wormwood, M.Serum ferritn concentration and iron
stores in normal subjects J. Clin pathol 26 770-1973

ADL/V.01/APR 2012

99
 4 x 0.5 mL
HbA1c DIRECT MULTICALIBRATOR 11604001
INTENDED USE
The reagent is intended for the calibration of photometric systems with HbA1c
Direct kit.
REAGENT COMPOSITION
Four levels Hemoglobin A1c calibrator set.
Lyophilized hemolysate prepared from human erythrocytes. Stabilizers to maintain
hemoglobin in the reduced state for the accurate calibration of the HbA1c
procedure.
Values are LOT specific please refer to table with lot specific assay data.
STORAGE AND STABILITY
The sealed vials are stable up to the expiry date stated on the label, when stored
at 2-8 0C.
PREPARATION & STABILITY OF THE CALIBRATOR
1. Open the vial carefully, avoiding any loss of the lyophilized material.
2. Add exactly 500 µl of deionized water (inaccurate reconstitution of the
calibrators and error in assay technique can cause erroneous results).
3. Close the vial carefully and gently mix for 10 minutes, or until all material has
dissolved, avoiding the formation of foam. Do not use shaker.
4. Reconstituted calibrators should be assayed in the same manner as blood
specimens including the hemolysate procedure (please refer to HbA1c Direct
pack insert. Code No: 11806001
4.1 Dispense 1 mL hemolysis Reagent (R3) into a tube.
4.2 Add 20 µL of calibrators and mix. Allow to stand for 5 minutes.
Note: The reconstituted calibrators are stable for 30 days at 2-80C, if protected from
light and heat. Do not freeze.
PRECAUTION
1. To avoid contamination, use clean laboratory wares.
2. Close the vials immediately after use. Protect from light and heat. Improper
handing and /or storage of the calibrators can affect results.
WARNING
Human source material. Each donor unit although tested negative for HbsAg, HCV,
HIV(1&2) treat as potentially infectious material.
BIBLIOGRAPHY
1. Nathan, D.M. clin. Chem.29 pp 466-469 (1983) Engbeak, F.et al. Clin.
Chem. 35 pp 93-97 (1989)
2. America Diabets Association : Clinical Practice recommendations (position
statement). Diabetes care 24 (suppl.1): S33-S55, (2001)
3. Tietz, N.W. Textbook of Clinical chemistry, W.B Saunders Company, p.
794- 7795 (1999)

ADL/V.01/APR 2012

100
 1 x 1 mL
RF CALIBRATOR 11617001
INTENDED USE
This reagent is intended for the preparation of calibration curve for RF estimation.
REAGENT COMPOSITION
RF calibrator prepared by diluting a high level of RF human plasma with saline. Solution
contains 0.05 g% Sodium azide as preservative.
STORAGE AND STABILITY
The sealed vials are stable up to expiry date at 2-80C, if protected from light.
PREPARATION AND STABILITY OF CALIBRATOR
Calibrator is stable liquid and the concentration will be mentioned on the vial. Generate
a calibration curve by diluting the calibrator as follows:
Preparation of calibration curve:
Prepare the following calibrator dilution using NaCI as diluent. Multiply the
concentration of the RF calibrator by the corresponding factors stated in the table
below to obtain the RF concentration of each dilution.
Dilution 1 2 3 4 5
Calib.(µL) 20 25 50 75 100
Saline(µL) 140 75 50 25 0
Dil. Factor 0.125 0.25 0.5 0.75 1

PRECAUTION
To avoid contamination, use clean laboratory wares. Close the vials immediately after
use. Protect from light and heat. Improper handling or storage of the calibrators can
affect results.
WARNING
Human source material. Each plasma donor unit although tested negative for HbsAg,
HCV, HIV(1&2) treat as potentially infectious material.
Reagents containing sodium azide must be handled with care.
BIBLIOGRAPHY
Frederick Wlofe et al. Arthritis and Rheumatism 1991: 34: 951-960

101
 2 x 0.5 mL
HbA1c CONTROL LEVEL 1 & 2 11625002
INTENDED USE
HbA1c control is an assayed quality control intended for monitoring the precision of
laboratory testing procedures.
CHARACTERISTICS
This product is prepared from human blood. The control is provided in liquid form.
To obtain consistent vial-to-vial assay values, the control requires proper storage and
handling as described.
STORAGE AND STABILITY
Unopened vial is stable until expiry date stated on the vial label at 2-8oC. Once control
is opened, all the analytes will be stable for 7 days when stored tightly capped at 2-
8oC.
EXPECTED VALUES
The expected values mentioned in the label are specific for this lot of product.
Determinations were performed under strictly standardized conditions on automated
analyzers using Agappe reagents.
PROCEDURE
To determine HbA1c a heamolysate must be prepared for each test procedure
1.Dispense 500 µL hemolysis reagent into a tube.
2.Add 10 µL of HbA1c control and mix.
3.Allow to stand for 5 minutes or until complete lysis is evident.
Follow the same procedure instructed for Sample and Calibrator
PRECAUTIONS AND WARNING
1. For in vitro diagnostic use only
2. Do not pipette by Mouth
3. If the control comes in contact with eye or skin, wash off immediately with large
amount of water, and seek medical attention immediately.
4. Do not use containers and other materials in the package for any purpose other
than those described herein.
5. When discarding the controls dispose of them according to local regulations
6. Attend to the normal precautions required for handling all laboratory reagents.
7. All human material should be considered as potentially infectious. All products
derived from human blood are prepared exclusively from the blood of donors
tested individually and shown to be free from HBsAg and antibodies to HCV and
HIV, The testing methods applied were FDA-approved or cleared in compliance with
European Directive 98/79/EC, Annex II, List A. However, as no testing with absolute
certainly, the material should be treated just as carefully as patient specimen.
8. Do not use HbA1c Control over the expiration date/stability period. Use clean and
dry micropipette tips and glassware to dispense HbA1c Control.

102
 1 x 1 mL
PROTEIN CONTROL ( IMMUNOLOGY CONTROL ) 11614005
INTENDED USE
Immunology control is an assayed quality control serum intended for monitoring the
precision of laboratory testing procedures.
CHARACTERISTICS
This product is prepared from human serum with added serum proteins. It is a
stabilized liquid product manufactured under rigid quality control standards. To obtain
consistent vial-to-vial assay values, the control requires proper storage and handling
as described.
STORAGE AND STABILITY
Unopened vial is stable until expiry date stated on the vial label at 2-8oC. Once opened,
this product will be stable for 30 days when stored tightly capped at 2-8oC.
EXPECTED VALUES
The expected values mentioned in the value sheet are specific for this lot of product.
Determinations were performed under strictly standardized conditions on automated
analyzers using Agappe reagents.
PRECAUTIONS AND WARNING
1. For in vitro diagnostic use only
2. Do not pipette by mouth
3. If the control comes in contact with eye or skin, wash off immediately with large
amount of water, and seek medical attention immediately.
4. Do not use containers and other materials in the package for any purpose other
than those described here in.
5. When discarding the reagents dispose of them according to local regulations
6. Attend to the normal precautions required for handling all laboratory reagents.
7. All human material should be considered as potentially infectious. All products
derived from human blood are prepared exclusively from the blood of donors
tested individually and shown to be free from HBsAg and antibodies to HCV and
HIV, The testing methods applied were FDA-approved or cleared in compliance with
European Directive 98/79/EC, Annex II, List A. However, as no testing can rule out
the presence with absolute certainty, the material should be treated just as
carefully as patient specimen.
8. Do not use immunology control over the expiration date/stability period.
9. Use clean and dry micropipette tips and glassware to dispense immunology
control.

103
 2 x 5 mL
QUALICHECK NORM & PATH 11601001
INTENDED USE
Qualicheck Norm & Path is an assayed human serum used for quality control
checking of clinical chemistry assays suitable for manual procedure and automated
analyzers.
CHARACTERISTICS
Qualicheck Normal or Pathologic is lyophilized control sera based on human serum.
The values given for routine methods, referred to hereafter as specified values, are
determined under routine conditions according to the method indicated using
different manual or automated assay instructions.
PREPARATION
Open the bottle very carefully, avoiding any loss of the lyophilized material and
add exactly 5 mL dist. water. Close bottle carefully and let stand for 30 minutes.
Dissolve contents completely by swirl gently, avoiding the formation of foam. DO
NOT SHAKE.
STABILITY
The expiry date for the lyophilized control serum is given on the pack
The components of the reconstituted control serum are stable for:-
At least 8 hours at +250C
At least 3 days at +40C
At least 1 month at - 200C when frozen once.
Bilirubin in the reconstituted control serum when stored in the dark is stable for:-
At least 2 hours at + 250C
At least 6 hours at 40C
At least 2 weeks at – 200C when frozen once.
NOTES
This product has been prepared exclusively from the blood of donors tested
individually by FDA approved methods and shown to be free from HbsAg and
antibodies to HIV 1 & 2.
As the risk of infection cannot be excluded with certainty, the product must be
handled just as the patient specimen.

ADL/V.01/APR 2012

104
ADL/V.01/APR 2012
 1 x 25mL /1 x4 mL
ALPHA 1-ACID GLYCOPROTEIN 12005054
INTENDED USE: This reagent is intended for in vitro quantitative determination of PERFORMANCE CHARACTERISTICS:
Alpha1- Acid Glycoprotein in human serum Measuring Range:- 4- 300 mg/dl.
-Turbidimetric Immunoassay If the concentration is greater than linearity (300 mg/dL), dilute the diluted sample
-Linear up to 300 mg/dL (1/10) with normal saline and repeat the assay. Multiply the result with dilution factor.
-Multipoint calibration Prozone Effect:- >600 mg/dL
CLINICAL SIGNIFICANCE Precision in CV%:-
Alpha-1-acid Glycoprotein is an acute-phase serum protein that is produced by the Low Medium High
liver in response to inflammation and infection. AGP is useful in monitoring tumor Intra - Run 4.66 1.14 2.45
recurrence. Levels are also helpful in differentiating acute phase responses (elevated
levels) from estrogen effects (normal or depressed levels). In addition, it is an Inter - Run 2.55
excellent protein in assessing in vivo hemolysis. Interference:-
PRINCIPLE No interference for
The reagents containing polyclonal goat antihuman AGP when mixed with the serum Hemoglobin upto 1000 mg/dL
sample containing AGP cause changes in absorbance, due to the development of Na- citrate upto 1000 mg/dL
turbidity, which is directly proportional to the concentration of Alpha 1- Acid
Glycoprotein in the sample. Heparin upto 50 mg/dL
REAGENT COMPOSITION Bilirubin upto 20 mg/dL
ALPHA 1- ACID GLYCOPROTEIN (AGP) R1 1 x 25 mL Triglyceride upto 2500 mg/dL
Phosphate buffered saline (pH 7.43) BIBLIOGRAPHY
Polyethylene glycol (60 g/L) 1. Schmid,K. in FW Putman,Editor, The plasma protein,Vol 1,second edition,
Academic Press, New York 2975, ppt 184-228
Sodium azide 2. Johnson, A.M. et al., J. Clin. Invest., 48 (1969)2293
(0.95 g/L) 3. Dati,F.et al.,Lab.Med. 13 (1989)87
ALPHA 1- ACID GLYCOPROTEIN (AGP) R2 1 x 4 mL
Phosphate buffered saline (pH 7.43)
Polyclonal goat anti-human Alpha 1- Acid Glycoprotein
(variable)
Sodium azide (0.95 g/L)

STORAGE AND STABILITY

The reagents are stable until expiry date when kept at 2-80C.
PRECAUTION
To avoid contamination, use clean laboratory wares. Use clean, dry disposable
pipette tips for dispensing. Close reagent bottles immediately after use. Avoid direct
exposure of reagent to light.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following values may be used as guide line.
Male : 50 - 130 mg/dL
Female : 40 - 120 mg/dL
SAMPLE
Use fresh serum. Dilute sample/control to 1/10 with saline.
CALIBRATION
Agappe Protein calibrator (11614002) is recommended for calibration of this assay.
Preparation of calibration curve:
Dilute the high concentrated calibrator 1/10 using saline and use this diluted
calibrator for the preparation of calibration curve.
Prepare the following calibrator dilution using NaCl as diluent. Multiply the
concentration of the AGP calibrator by the corresponding factor stated in the table
below to obtain the AGP concentration of each dilution.
Dilution 1 2 3 4 5 6
1/10 dil.cal.(µL) - 10 10 25 50 100
Saline (µL) 100 150 70 75 50 -
Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
Quality Control
It is recommended to use Agappe protein control(11614003) to verify the
performance of the assay. Each laboratory has to establish its own internal quality
control scheme and procedure for corrective action, if controls do not recover with
in the acceptable tolerance.

ADL/V.01/APR 2012
ALPHA 1-ACID GLYCOPROTEIN
Parameters Screen Calibration Screen
Test AGP Rule Spline
No Sensitivity
Full Name AGP Replicates 1
Standard No. 6 Interval ( day) 0
Reaction Type Endpoint Difference Limit
Primary WL 340 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time -1 22 Determination Coeff. 0
Incubation Time 20 QC Screen
Unit mg/dL Control 1
Precision 0.01 Control 2
R1 300 µL
R2 30 µL
Sample 3 µL
R1 Blank
Mixed Rgt.Blank
Linearity Range 4 300
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Reference Screen
Low
High

ADL/V.01/APR 2012
 1 x 35mL /1 x6mL
C3 12005051
INTENDED USE: This reagent is intended for in vitro quantitative determination of PERFORMANCE CHARACTERISTICS:
complement C3 in human serum. Measuring Range:- 20 –400 mg/dL.
-Turbidimetric Immunoassay If the concentration is greater than linearity (400 mg/dL), dilute the diluted sample
-Linear up to 400 mg/dL (1/10) with normal saline and repeat the assay. Multiply the result with dilution factor.
-Multipoint calibration Prozone Effect : >1000mg/dL
CLINICAL SIGNIFICANCE Precision in CV% :
complement C3 is the central point of the classic and alternative complement Low Medium High
pathway. Intra - Run 2.82 3.43 3.28
Complement testing help to diagnose the cause of recurrent microbial infections,
angioedema, or inflammation. It may be used to help diagnose and to monitor the Inter - Run 3.71 2.56
activity of acute or chronic autoimmune diseases such as Systemic Lupus Interference:- No interference for
Erythematosus (SLE). Hemoglobin upto 1000 mg/dL
Decreased levels of C3 are significant in autoimmune disease, immune infections Na-citrate upto 1000 mg/dL
with pyrogenic bacteria, bacteremia, neonatal respiratory distress syndrome and Heparin upto 50 mg/dL
congenital deficiencies.C3 behaves as an acute phase protein hence increased levels
may found in acute inflammatory reactions. Bilirubin upto 20 mg/dL
PRINCIPLE Triglyceride upto 2500 mg/dL
The reagents containing polyclonal goat antihuman C3 when mixed with the serum BIBLIOGRAPHY
sample containing C3 cause changes in absorbance, due to the development of 1. Dati, F. et al., Lab. Med.13, 87 (1989)
turbidity, which is directly proportional to the concentration of C3 in the sample. 2. Muller-Eberhard, H.H., Ann. Rev.Biochem.44, 697(1975)
REAGENT COMPOSITION 3. Lachmann, P.J., Hobart, M.J. and Ashton, W.P. (1973)
C3 R1 1 x 35 mL
Phosphate buffered saline (pH 7.43)
Polyethylene glycol (40 g/L)
Sodium azide (0.95 g/L)
C3 R2 1 x 6 mL
Phosphate buffered saline (pH 7.43)
Polyclonal goat anti-human C3C (variable)
Sodium azide (0.95 g/L)

STORAGE AND STABILITY

The reagents are stable until expiry date when kept at 2-80 C
PRECAUTION
To avoid contamination, use clean laboratory wares. Use clean, dry disposable
pipette tips for dispensing. Close reagent bottles immediately after use. Avoid direct
exposure of reagent to light.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following values may be used as guide line.
Serum 75-135 mg/dL
SAMPLE
Use fresh serum. Dilute sample/control to 1/10 with saline. If the test cannot be
carried out on the same day, the serum may be stored at 2-80 C for 48 hours.
CALIBRATION
Agappe Protein calibrator (11614002) is recommended for calibration of this assay.
Preparation of calibration curve:
Dilute the calibrator to 1/10 using normal saline and use this diluted calibrator for
the preparation of the calibration curve. Prepare the following calibrator dilution
using NaCl as diluent. Multiply the concentration of the C3 calibrator by the
corresponding factors stated in the table below to obtain the C3 concentration of each
dilution.
Dilution 1 2 3 4 5 6
1/10 Cali. (µL) - 10 10 25 50 100
Saline (µL) 100 150 70 75 50 -
Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
Quality Control
It is recommended to use Agappe protein control(11614003) to verify the
performance of the assay. Each laboratory has to establish its own internal quality
control scheme and procedure for corrective action, if controls do not recover with
in the acceptable tolerance.

ADL/V.01/APR 2012
C3
Parameters Screen Calibration Screen
Test C3 Rule Spline
No Sensitivity
Full Name C3 Replicates 1
Standard No. 6 Interval ( day) 0
Reaction Type Endpoint Difference Limit
Primary WL 340 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time -1 22 Determination Coeff. 0
Incubation Time 20 QC Screen
Unit mg/dL Control 1
Precision 0.01 Control 2
R1 200 µL
R2 30 µL
Sample 3 µL
R1 Blank
Mixed Rgt.Blank
Linearity Range 20 400
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Reference Screen
Low
High

ADL/V.01/APR 2012
 1 x35 mL/1x6mL
C4 12005052
INTENDED USE PERFORMANCE CHARACTERISTICS:
This reagent is intended for in vitro quantitative determination of complement C4 in Measuring Range:- 2 –80 mg/dL.
human serum. If the concentration is greater than linearity (80 mg/dL), dilute the diluted sample (1/
-Turbidimetric Immunoassay 10) with normal saline and repeat the assay. Multiply the result with dilution factor.
-Linear up to 80 mg/dL Prozone Effect:- >1000mg/dL
-Multipoint calibration Precision in CV%:-
CLINICAL SIGNIFICANCE Low Medium High
C4 is a constituent of C3 convertase & C5 convertase. Intra - Run 4.54 2.18 3.96
Decreased levels are found in hereditary angioneurotic odema, immune complex Inter - Run 4.17 3.08
disease and congenital deficiencies. Interference:-
PRINCIPLE No interference for
The reagents containing polyclonal goat antihuman C4 when mixed with the serum Hemoglobin upto 1000 mg/dL
sample containing C4 cause changes in absorbance, due to the development of Na-citrate upto 1000 mg/dL
turbidity, which is directly proportional to the concentration of C4 in the sample. Heparin upto 50 mg/dL
REAGENT COMPOSITION Turbidity upto 5%
C4 R1 1 x 35 mL Bilirubin upto 20 mg/dL
Phosphate buffered saline (pH7.43) Triglyceride upto 2500 mg/dL
Polyethylene glycol (40 g/L) BIBLIOGRAPHY
Sodium azide (0.95 g/L) 1. Dati, F. et al., Lab. Med.13, 87 (1989)
C4 R2 1 x 6 mL 2. Muller-Eberhard, H.H., Ann. Rev.Biochem.44, 697(1975) Lachmann, P.J., Hobart,
Phosphate buffered saline (pH 7.43) M.J. and Ashton, W.P. (1973)
Polyclonal goat anti-human C4C (variable)
Sodium azide (0.95 g/L)
STORAGE AND STABILITY
The reagents are stable until expiry date when kept at 2-80 C.
PRECAUTION
To avoid contamination, use clean laboratory wares. Use clean, dry disposable pipette
tips for dispensing. Close reagent bottles immediately after use. Avoid direct exposure
of reagent to light.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following values may be used as guide line.
Serum : 9 - 36 mg/dL
SAMPLE
Use fresh serum. Dilute the sample/control to 1/10 with saline. If the test cannot be
carried out on the same day, the serum may be stored at 2-80 C for 48 hours.
CALIBRATION
Agappe Protein calibrator (11614002) is recommended for calibration of this assay.
Preparation of calibration curve:
Dilute the high concentration calibrator to 1/10 with normal saline and use this diluted
calibrator for the preparation of calibration curve. Prepare the following calibrator
dilution using NaCl as diluent. Multiply the concentration of the C4 calibrator by the
corresponding factors stated in the table below to obtain the C4 concentration of each
dilution.
Dilution 1 2 3 4 5 6
1/10 dil.Cali. (µL) - 10 10 25 50 100
Saline (µL) 100 150 70 75 50 -
Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
Quality Control
It is recommended to use Agappe protein control(11614003) to verify the
performance of the assay. Each laboratory has to establish its own internal quality
control scheme and procedure for corrective action, if controls do not recover with
in the acceptable tolerance.

ADL/V.01/APR 2012
C4
Parameters Screen Calibration Screen
Test C4 Rule Spline
No Sensitivity
Full Name C4 Replicates 1
Standard No. 6 Interval ( day) 0
Reaction Type Endpoint Difference Limit
Primary WL 340 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time -1 22 Determination Coeff. 0
Incubation Time 20 QC Screen
Unit mg/dL Control 1
Precision 0.01 Control 2
R1 200 µL
R2 30 µL
Sample 3 µL
R1 Blank
Mixed Rgt.Blank
Linearity Range 0 80
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Refence Screen
Low
High

ADL/V.01/APR 2012
 1 x 35/1x6mL
APO A1 12005030
INTENDED USE : This reagent is intended for in vitro quantitative determination of PERFORMANCE CHARACTERISTICS:
Apolipoprotein A1 in serum or plasma. Measuring Range:- 4 - 300 mg/dL.
-Turbidimetric Immunoassay If the concentration is greater than 300mg/dl dilute the diluted sample (1/10) with
-Linear up to 300 mg/dL normal saline and repeat the assay. Multiply the result with dilution factor.
-Multipoint calibration. Prozone Effect:- >5500mg/dL
CLINICAL SIGNIFICANCE Precision in CV%:-
Apo A1 is the main protein component of HDL. Apo A1 activates lecithin cholesterol Low Medium High
acyltransferase which catalyses the esterification of cholesterol this can then be Intra - Run 3.05 1.12 1.48
transported to the liver, metabolized and excreted. People with atherosclerotic
vascular changes frequently exhibit decreased levels of Apo A1. Even if the Inter - Run 1.63
concentrations of apolipoprotein B are normal, a decreased ApoA1 level may be a Hemoglobin 1000mg/dL
risk factor for atherosclerosis. Decreased levels of ApoA1 also occur in Triglyceride 2500 mg/dL
dyslipoproteinemias, acute hepatic cirrhosis and insulin treated patients.
Bilirubin 20mg /dL
PRINCIPLE
BIBLIOGRAPHY
Anti-human Apo A1 antisera when mixed with human serum containing Apo A1,
react to cause an absorbance change , which is measured by immunoturbidometric 1. Tillett. W. S.et al: serological reactions in pneumonia with a non-protein samatic
principle. The change in the absorbance can be interpolated in a calibration curve fraction of pneumococcus. J.Exp.Med..52,561(1930)
prepared with different known concentrations of calibrator. 2. Ziegenhagen G, Drahovshy D. klinishe Bedeutung des Creaktiven protein. Med
klin 1983;78:45-50.
REAGENT COMPOSITION 3. Rifal. N.Tracy.R.P.Ridker, P.M.clinical efficacy of an Automated high sensitivity
Apo A1 R1 1 x 35 mL C-Reactive protein Assay, Clin. chem. 45:12.
Phosphate buffered saline(pH 7.43)
Polyethylene glycol 60 g/L
Detergent 0.1%
Sodium azide 0.95 g/L
Apo A1 R2 1 x 6 mL
Phosphate buffered saline(pH 7.43)
Polyclonal goat anti-human Apo-A1(Variable)
Sodium azide 0.95g/L

STORAGE AND STABILITY

The sealed reagents are stable up to expiry date stated on the label, when stored
at 2 - 8oC.
PRECAUTION
To avoid contamination, use clean laboratory wares; use clean dry disposable
pipette tips for dispensing, close reagent bottle immediately after use . Avoid direct
exposure of reagent to light.
REFERENCE RANGE
It is recommended that , each laboratory establish its own
reference values. The following values may be used as guidelines.
Men : 107 - 177 mg/dL
Women : 107 - 205 mg/dL
SAMPLE
Use fresh serum. Dilute sample/control to 1 /10 with saline
CALIBRATION
Agappe ApoA1&B calibrator (11613002) is recommended for calibration of this
assay.
Preparation of calibration curve:
Reconstitute the Apo A1 calibrator with 1 mL of distilled water. The reconstituted
calibrator is stable for 7 days at 2-8oC.
Dilute the high concentrated calibrator 1/10 using saline and use this diluted
calibrator for the preparation of calibration curve.
Prepare the following calibrator dilution using NaCl as diluent. Multiply the
concentration of the Apo A1 calibrator by the corresponding factors stated in the table
below to obtain the Apo A1 concentration of each dilution.
Dilution 1 2 3 4 5 6
1/10dilCali. (µL) - 10 10 20 50 100
Saline (µL) 100 150 70 60 50 -
Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
Quality Control
It is recommended to use Agappe control to verify the performance of the assay.
Each laboratory has to establish its own internal quality control scheme and
procedure for corrective action, if controls do not recover with in the acceptable
tolerance.

ADL/V.01/APR 2012
APO A1
Parameters Screen Calibration Screen
Test APO A1 Rule Spline
No Sensitivity
Full Name Apo A1 Replicates 1
Standard No. 6 Interval ( day) 0
Reaction Type Endpoint Difference Limit
Primary WL 340 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time -1 22 Determination Coeff. 0
Incubation Time 20 QC Screen
Unit mg/dL Control 1
Precision 0.01 Control 2
R1 225 µL
R2 37 µL
Sample 3 µL
R1 Blank
Mixed Rgt.Blank
Linearity Range 4 300
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Reference Screen
Low
High

ADL/V.01/APR 2012
 1 x 35mL/1 x 6 mL
APO B 12602001
INTENDED USE : This reagent is intended for in vitro quantitative determination of PERFORMANCE CHARACTERISTICS:
Apo B in serum. Measuring Range:- 8 - 330 mg/dL.
-Turbidometric Immuno assay If the concentration is greater than 300 mg/dL, dilute the diluted sample (1/10) with
-High Linearity of 330 mg/dL normal saline and repeat the assay. Multiply the result with dilution factor.
-Multi point calibration Prozone Effect:- >5000mg/dL
CLINICAL SIGNIFICANCE Precision in CV%:-
Apo B is the main protein component of LDL. It is necessary for the reaction with Low Medium High
LDL receptors in the liver and on cell walls and thus involved in transporting Intra - Run 5.24 1.16 0.91
cholesterol, from the liver to the vessel cells.
Elevated levels of Apo-B are frequently found in atherosclerotic vascular changes Inter - Run 1.02
and are a risk factor for atherosclerosis. Interference:-No interference for
PRINCIPLE Hemoglobin 1000mg/dL
The reagents containing polyclonal goat antihuman Apo-B antibodies when mixed Triglyceride 2500 mg/dL
with the serum sample containing Apo-B cause changes in absorbance due to Bilirubin 20mg /dL
the development of turbidity, which is directly proportional to the concentration BIBLIOGRAPHY
of Apo-B in the sample.
1. Tillett. W.S. et al: Serological reactions in Pneumonia a non-protein somatic
REAGENT COMPOSITION fraction of pneumococcus. J. Exp.Med..52,561(1930)
Apo B R1 1 x 35 mL 2. Ziegenhagen G, Drahovshy D. klinishe Bedeutung des Creaktiven protein.
Phosphate buffered saline(pH 7.43) Med klin 1983;78:45-50.
Polyethyleneglycol 60 g/L 3. Rifal. N.Tracy.R.P.Ridker, P.M.clinical efficacy of an
Detergent 0.1% Automated High sensitivity C-Reactive protein Assay Clin chem. 45:12.
Sodium azide. 0.95 g/L
Apo B R2 1 x 6 mL
Polyclonal goat anti-human Apo-B(Variable)
Sodium azide 0.95 g/L
Phosphate buffer pH 7.43

STORAGE AND STABILITY

The sealed reagents are stable upto the expiry date mentioned on the label when
stored at 2-8oC.
PRECAUTION
To avoid contamination, use clean laboratory wares, such as pipette tips and test
tubes. Close reagent bottle immediately after use. Avoid direct exposure of reagent
to light
REFERENCE RANGE
It is recommended that, each laboratory establishes its own reference values. The
following values may be used as reference.
Men : 60 - 138 mg/dL
Women : 52 - 129 mg/dL
SAMPLE
Use fresh serum . Dilute sample/ control to 1/10 in saline
CALIBRATION
Agappe Protein calibrator (11614002) is recommended for calibration of this assay.
Preparation of calibration curve:
Reconstitute the Apo B calibrator with 1 mL of distilled water. The reconstituted
calibrator is stable for 7 days at 2-8oC. Dilute the high concentrated calibrator 1/10
using saline and use this diluted calibrator for the preparation of calibration curve.
Prepare the following calibrator dilution using NaCl as diluent. Multiply the
concentration of the Apo B calibrator by the corresponding factor stated in the table
below to obtain the Apo B concentration of each dilution.

Dilution 1 2 3 4 5 6
1/10Dil.cal.(µL) - 10 10 20 50 100
Saline (µL) 100 150 70 60 50 -
Dil. factor 0 0.0625 0.125 0.25 0.5 1.0

ADL/V.01/APR 2012
APO B
Parameters Screen Calibration Screen
Test APO B Rule Spline
No Sensitivity
Full Name Apo B Replicates 1
Standard No. 6 Interval ( day) 0
Reaction Type Endpoint Difference Limit
Primary WL 340 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time -1 22 Determination Coeff. 0
Incubation Time 20 QC Screen
Unit mg/dL Control 1
Precision 0.01 Control 2
R1 225 µL
R2 37 µL
Sample 3 µL
R1 Blank
Mixed Rgt.Blank
Linearity Range 8 330
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Reference Screen
Low
High

ADL/V.01/APR 2012
 1 x 35 mL/1 x6 mL
CERULOPLASMIN 12005032
INTENDED USE : This reagent is intended for in vitro quantitative determination of PERFORMANCE CHARACTERISTICS:
Ceruloplasmin in serum. Measuring Range:- 4 - 100 mg/dL.
-Turbidimetric Immuno assay If the concentration is greater than 100 mg/dl , dilute the sample with normal saline
-Linear up to 100 mg/dL and repeat the assay. Multiply the result with dilution factor.
-Multipoint calibration Prozone Effect:- >400mg/dL
CLINICAL SIGNIFICANCE Precision in CV%:-
Ceruloplasmin is a copper oxidase enzyme, important in regulating the ionic state Low Medium High
of iron and other metallic ions. Levels are decreased in hepatolenticular Intra - Run 6.31 2.07 2.20
degeneration or Wilson's disease and Menke's kinky hair syndrome. Levels are
elevated by the acute phase response and particularly by estrogens. Inter - Run 3.91
PRINCIPLE Interference:-
The reagents containing polyclonal goat antihuman ceruloplasmin when mixed with No interference for
the serum sample containing ceruloplasmin cause changes in absorbance due to Hemoglobin upto 1000 mg/dL
the development of turbidity, which is directly proportional to the concentration Na - citrate upto 1000 mg/dL
of Ceruloplasmin in the sample.
Heparin upto 50 mg/dL
REAGENT COMPOSITION
Bilirubin upto 20 mg/dL
Ceruloplasmin - R1 1 x 35 mL
Triglycerides upto 2500 mg/dL
Phosphate buffered saline (pH 7.43)
BIBLIOGRAPHY
Polyethylene glycol 40 g/L
Poulik , M.D and Kleiss M.L in The plasma proteins”, F.W. Putman, editor,Vol. 2
Sodium azide 0.95 g/L second edition, Academic press, New York, PP 52-108
Ceruloplasmin - R2 1 x 6 mL
Phosphate buffered saline (pH 7.43)
Polyclonal goat anti- human Ceruloplasmin
Sodium azide 0.95 g/L

STORAGE AND STABILITY

The sealed reagents are stable upto the expiry date mentioned on the label when
stored at 2-8oC. Do not freeze.
PRECAUTION
To avoid contamination, use clean laboratory wares, such as pipette tips and test
tubes. Close reagent bottle immediately after use. Avoid direct exposure of reagent
to light.
REFERENCE RANGE
It is recommended that, each laboratory should establishes its own reference values.
The following value may be used as a reference.
serum : 22 - 61 mg/dL
SAMPLE
Fresh serum.
CALIBRATION
Agappe Protein calibrator (11614002) is recommended for calibration of this assay.
Preparation of calibration curve:
Prepare the following calibrator dilution using NaCl as diluent. Multiply the
concentration of the Ceruloplasmin calibrator by the corresponding factors stated in
the table below to obtain the Ceruloplasmin concentration of each dilution.
Dilution 1 2 3 4 5 6
Cali. (µL) - 10 10 20 50 100
Saline (µL) 100 150 70 60 50 -
Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
Quality Control
It is recommended to use Agappe protein control(11614003) to verify the
performance of the assay. Each laboratory has to establish its own internal quality
control scheme and procedure for corrective action, if controls do not recover with
in the acceptable tolerance.

ADL/V.01/APR 2012
CERULOPLASMIN
Parameters Screen Calibration Screen
Test Ceruloplasmin Rule Spline
No Sensitivity
Full Name Ceruloplasmin Replicates 1
Standard No. 6 Interval ( day) 0
Reaction Type Endpoint Difference Limit
Primary WL 340 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time -1 22 Determination Coeff. 0
Incubation Time 20 QC Screen
Unit mg/dL Control 1
Precision 0.01 Control 2
R1 225 µL
R2 37 µL
Sample 3 µL
R1 Blank
Mixed Rgt.Blank
Linearity Range 4 100
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Reference Screen
Low
High

ADL/V.01/APR 2012
 1 x25mL /1 x 4 mL
PREALBUMIN 12005055
INTENDED USE: This reagent is intended for in vitro quantitative determination of Low Medium High
Prealbumin in human serum Intra - Run 5.30 3.04 3.96
-Turbidimetric Immunoassay
Inter - Run 6.22 4.71 4.1
-Linear up to 80 mg/dL
CLINICAL SIGNIFICANCE Interference:-
Prealbumin is a serum and cerebrospinal fluid carrier of the thyroid hormone No interference for
thyroxine (T4) and retinol. So the more accurate name for prealbumin is Hemoglobin 1000mg/dL
transthyretin . Triglyceride 2500 mg/dL
Prealbumin is formed in the liver, it is a measure of hepatocyte function. Decreased Bilirubin 20mg /dL
and increased levels of serum prealbumin are associated with liver disease and are BIBLIOGRAPHY
affected by the existence and degree of liver diseases. 1. Japanese Journal of Clinical Medicine,53(enlarged) , 186 – 188 (1995)
The half life of prealbumin is approximately 2 days, making prealbumin a more 2. Journal of Clinical Experimental Medicine , 149 (5) , 277 – 279 (1989)
timely and sensitive indicator of protein status.
PRINCIPLE
Antibodies to prealbumin are combined with prealbumin in the patient’s serum,
forming immune complexes.The immune complexes cause an increase in the light
scattering with the concentration of prealbumin in the serum. The light scattering
is measured by reading turbidity at 340 nm and 700 nm.
REAGENT COMPOSITION
Prealbumin R1(Buffer Solution) 1 x 25 mL
Tris (hydroxymethyl) aminomethane 100 mmol/L
Prealbumin R2 (Anti Serum Solution) 1 x 4 mL
Anti- human prealbumin anti serum(Variable)

STORAGE AND STABILITY

The reagents are stable until expiry date when kept at 2-80 C.
PRECAUTION
To avoid contamination, use clean laboratory wares. Use clean, dry disposable
pipette tips for dispensing. Close reagent bottles immediately after use. Avoid direct
exposure of reagent to light.
NORMAL RANGE
It is recommended that each laboratory should establish its own reference values.
The following values may be used as guide line.
Male : 23 - 42 mg/dL
Female : 22 - 34 mg/dL
SAMPLE
Use fresh serum. Dilute sample/control to 1/10 with saline.
CALIBRATION
Agappe Protein calibrator (11614002) is recommended for calibration of this assay.
Preparation of calibration curve:
Dilute the high concentrated calibrator to 1/10 using saline and use this diluted
calibrator for the preparation of calibration curve. Prepare the following calibrator
dilutions using NaCl as diluent. Multiply the concentration of the Prealbumin
calibrator by the corresponding factor stated in the table below to obtain the
Prealbumin concentration of each dilution.
Dilution 1 2 3 4 5 6
Cali.1/10 dil(µL) - 10 10 20 50 100
Saline (µL) 100 150 70 60 50 -
Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
Quality Control
It is recommended to use Agappe protein control(11614003) to verify the
performance of the assay. Each laboratory has to establish its own internal quality
control scheme and procedure for corrective action, if controls do not recover with
in the acceptable tolerance.
PERFORMANCE CHARACTERISTICS:
Measuring Range:- 5 –80 mg/dL.
If the concentration is greater than 80 mg/dL, dilute the diluted sample (1/10) with
normal saline and repeat the assay. Multiply the result with dilution factor.
Prozone Effect:- >200mg/dL
Precision in CV%:-

ADL/V.01/APR 2012
PREALBUMIN
Parameters Screen Calibration Screen
Test Pre Alb Rule Spline
No Sensitivity
Full Name Pre Alb Replicates 1
Standard No. 6 Interval ( day) 0
Reaction Type Endpoint Difference Limit
Primary WL 340 SD
Sec. WL 670 Blank Response
Direction Increase Error Limit
Reaction Time -1 22 Determination Coeff. 0
Incubation Time 20 QC Screen
Unit mg/dL Control 1
Precision 0.01 Control 2
R1 300 µL
R2 30 µL
Sample 15 µL
R1 Blank
Mixed Rgt.Blank
Linearity Range 5 80
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Reference Screen
Low
High

ADL/V.01/APR 2012
 1 x 25mL /1 x 4mL
TRANSFERRIN 12005056
INTENDED USE: This reagent is intended for in vitro quantitative determination of PERFORMANCE CHARACTERISTICS:
Transferrin in human serum Measuring Range:- 40 – 540 mg/dL.
-Turbidimetric Immunoassay If the concentration is greater than 540 mg/dL, dilute the diluted sample (1/10) with
-Linear up to 540 mg/dL normal saline and repeat the assay. Multiply the result with dilution factor.
-Multipoint calibration Prozone Effect:- >1400mg/dL
CLINICAL SIGNIFICANCE Precision in CV%:-
Transferrin(TF) is synthesised in Liver. The main role of Transferrin is to deliver Low Medium High
iron from absorption centres to all tissues. Increased serum Transferrin is associated Intra - Run 4.78 1.30 0.78
with iron deficiency anemia, malignant tumor, polycythemia rubra. Increased levels
of serum transferrin are observed in patients with aplastic anemia, hemolytic Inter - Run 4.64 2.46 0.9
anemia and hepatitis. Absence of Transferrin in the body creates a rare genetic INTERFERING SUBSTANCES
disorder known as atransferrinemia; a condition characterized by anemia and No interference for
hemosiderosis in the heart and liver that leads to many complications including
heart failure. Hemoglobin upto 1000 mg/dL
PRINCIPLE Bilirubin upto 20 mg/dL
Antibodies to human TF are combined with transferrin in the patients serum, Lipemia upto 5 % of intralipid
forming immune complexes. The immune complexes cause an increase in light BIBLIOGRAPHY
scattering which correlate with the concentration of TF in the serum. The light 1. K. Bergstorm, et al.: J.Clin Lab Invest., 40, 637-640 (1980)
scattering is measured by reading turbidity at 340 nm. 2. H. Maikus, et al.: Clinica Chemica Acta, 88, 523-530(1978)
REAGENT COMPOSITION
Transferrin R1(Buffer solution) 1 x 25 mL
Tris (hydroxymethyl) aminomethane 100 mmol/L
Transferrin R2(Anti serum solution) 1 x 4 mL
Anti- human TF anti serum (Variable)

STORAGE AND STABILITY

The reagents are stable until expiry date when kept at 2-80 C .
PRECAUTION
To avoid contamination, use clean laboratory wares. Use clean, dry disposable
pipette tips for dispensing. Close reagent bottles immediately after use. Avoid direct
exposure of reagent to light.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following values may be used as guide line.
Male : 190 - 300 mg/dL
Female : 200 - 340 mg/dL
SAMPLE
Use fresh serum. Dilute serum/control to 1/10 with saline.
CALIBRATION
Agappe Protein calibrator (11614002) is recommended for calibration of this assay.
Preparation of calibration curve:
Dilute the high concentrated calibrator 1/10 with normal saline and use this diluted
calibrator for the preparation of calibration curve.
Prepare the following calibrator dilutions using NaCl as diluent. Multiply the
concentration of the Transferrin calibrator by the corresponding factors stated in the
table below to obtain the Transferrin concentration of each dilution.
Dilution 1 2 3 4 5 6
1/10dilcali.(µl) - 10 10 25 50 100
Saline (µL) 100 150 70 75 50 -
Dil. factor 0 0.0625 0.125 0.25 0.5 1
Quality Control
It is recommended to use Agappe protein control(11614003) to verify the
performance of the assay. Each laboratory has to establish its own internal quality
control scheme and procedure for corrective action, if controls do not recover with
in the acceptable tolerance.

ADL/V.01/APR 2012
TRANSFERRIN
Parameters Screen Calibration Screen
Test Trans Rule Spline
No Sensitivity
Full Name TRF Replicates 1
Standard No. 6 Interval ( day) 0
Reaction Type Endpoint Difference Limit
Primary WL 670 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time -1 22 Determination Coeff. 0
Incubation Time 20 QC Screen
Unit mg/dL Control 1
Precision 0.01 Control 2
R1 300 µL
R2 30 µL
Sample 8.5 µL
R1 Blank
Mixed Rgt.Blank
Linearity Range 40 540
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Reference Screen
Low
High

ADL/V.01/APR 2012
 1 x 30/1 x 10 mL
IgM 12005037
INTENDED USE : This reagent is intended for in vitro quantitative determination of PERFORMANCE CHARACTERISTICS:
IgM antibodies in serum. Measuring Range:- 6 – 500 mg/dL.
-Turbidimetric Immuno assay If the concentration is greater than 500 mg/dL, dilute the sample with normal saline
-Linear up to 500 mg/dL and repeat the assay. Multiply the result with dilution factor.
-Multipoint calibration Prozone Effect:- >5000mg/dL
CLINICAL SIGNIFICANCE Precision in CV%:-
IgM is important in early response to infections . The measurement of IgM is Low Medium High
important for typing immuno deficiencies and myelomas. IgM plays an important Intra - Run 1.43 1.59 0.64
role in the humoral defense of the body. Serum levels may be increased in all kind
of acute infections. Elevated levels in cord serum suggest clinical infection in the Inter - Run 3.17 3.65 2.49
new born. Interference:-
PRINCIPLE No interference for
Antibodies to IgM are combined with IgM in the patient’s serum, forming immune Hemoglobin 1000 mg/dL
complexes. The immune complexes cause an increase in light scattering which Triglyceride 2500 mg/dL
correlate with the concentration of IgM in the serum. The light scattering is
measured by reading turbidity at 340 nm and 700 nm. Bilirubin 20mg /dL
REAGENT COMPOSITION Turbidity 5%
IgM R1 (Buffer solution) 1 x 30 mL BIBLIOGRAPHY
Tris(hydroxymethyl)aminomethane 100 mmol/L 1. Otani,H. :Medical Technology,14, 965(1986)
2. Rinsho Kensa Guide 1992, 269-274(1992) Published by BUNKODO CO., LTD
IgM R2 (Antiserum solution) 1 x 10 mL 3. Kanai’s manual of Clinical laboratory Medicine, the 30 th edition,868-
Anti-human IgM antiserum 873(1993)published by KANEHARA & CO.,LTD

STORAGE AND STABILITY

The sealed reagents are stable upto the expiry date mentioned on the label when
stored at 2-8 0C. Do not freeze.
PRECAUTION
To avoid contamination, use clean laboratory wares. Avoid direct exposure of
reagent to light.
The reagent should be used according to this pack insert. If used otherwise,
appropriate performance is not guaranteed.
REFERENCE RANGE
It is recommended that each laboratory establish its own reference values. The
following values may be used as reference.
Serum : 35 - 220 mg/dL
SAMPLE
Fresh Serum.
CALIBRATION
Agappe Protein calibrator (11614002) is recommended for calibration of this assay.
Preparation of calibration curve:
Prepare the following calibrator dilutions using NaCl as diluent. Multiply the
concentration of the IgM calibrator by the corresponding factor stated in the table
below to obtain the IgM concentration of each
Dilution 1 2 3 4 5 6
Cal. (µL) - 10 10 20 50 100
Saline (µL) 100 150 70 60 50 -
Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
Quality Control
It is recommended to use Agappe protein control(11614003) to verify the
performance of the assay. Each laboratory has to establish its own internal quality
control scheme and procedure for corrective action, if controls do not recover with
in the acceptable tolerance.

ADL/V.01/APR 2012
IgM
Parameters Screen Calibration Screen
Test IgM Rule Spline
No Sensitivity
Full Name IgM Replicates 1
Standard No. 6 Interval ( day) 0
Reaction Type EP Difference Limit
Primary WL 340 SD
Sec. WL 670 Blank Response
Direction Increase Error Limit
Reaction Time -1 22 Determination Coeff. 0
Incubation Time 18 QC Screen
Unit mg/dL Control 1 *
Precision 0.1 Control 2 *
R1 210 µL
R2 70 µL
Sample 3 µL
R1 Blank
Mixed Rgt.Blank
Linearity Range 6 500
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Reference Screen
Low *
High *
* Data entered by the operator

ADL/V.01/APR 2012
 1 x 15mL/1 x 15 mL
IgG 12005036
INTENDED USE : This reagent is intended for in vitro quantitative determination of PERFORMANCE CHARACTERISTICS:
IgG antibodies in serum. Measuring Range:- 90 –2700 mg/dL.
-Turbidimetric Immuno assay If the concentration is greater than 2700 mg/dL, dilute the diluted sample (1/10) with
-High linearity of 2700 mg/dL normal saline and repeat the assay .Multiply the result with dilution factor.
-Multipoint calibration Prozone Effect:- >10000mg/dL
CLINICAL SIGNIFICANCE Precision in CV%:-
IgG is a predominant serum immunoglobulin . The measurement of IgG is important Low Medium High
for typing immunodeficiencies and myelomas. Increased levels are found in chronic Intra - Run 2.5 3.25 4.18
infections and chronic inflammation. IgG is the only immunoglobulin which crosses
the placenta and is therefore of special importance in infants defense against Inter - Run 4.08 1.83
infection. Interference:-
PRINCIPLE No interference for
Antibodies to IgG are combined with IgG in the patient’s serum, forming immune Hemoglobin 1000 mg/dL
complexes. The immune complexes cause an increase in light scattering which Triglyceride 2500 mg/dL
correlate with the concentration of IgG in the serum. The light scattering is
measured by reading turbidity at 700 nm. Bilirubin 20mg/dL
REAGENT COMPOSITION BIBLIOGRAPHY
IgG R1 (Buffer solution) 1 x 15 mL 1. Otani,H. :Medical Technology,14, 965(1986)
2. Rinsho Kensa Guide 1992, 269-274(1992) Published by BUNKODO CO., LTD
Tris(hydroxymethyl)aminomethane 100 mmol/L 3. Kanai’s manual of Clinical laboratory Medicine, the 30 th edition,868-
IgG R2 (Antiserum solution) 1 x 15 mL 873(1993)published by KANEHARA & CO.,LTD
Anti-human IgG antiserum

STORAGE AND STABILITY

The sealed reagents are stable upto the expiry date mentioned on the label when
stored at 2-8 0C.
PRECAUTION
To avoid contamination, use clean laboratory wares, such as pipette tips and test
tubes. Close reagent bottle immediately after use. Avoid direct exposure of reagent
to light.
REFERENCE RANGE
It is recommended that , each laboratory should establish its own reference values.
The following value may be used as a reference.
serum : 870 - 1700 mg/dL
SAMPLE
Use fresh serum. Dilute sample/control to 1/10 with saline.
CALIBRATION
Agappe Protein calibrator (11614002) is recommended for calibration of this assay.
Preparation of calibration curve:
Dilute the high concentration calibrator to 1/10 using normal saline and use this
diluted calibrator for the preparation of calibration curve.
Prepare the following calibrator dilutions using NaCl as diluent. Multiply the
concentration of the IgG calibrator by the corresponding factor stated in the table
below to obtain the IgG concentration of each dilution.
Dilution 1 2 3 4 5 6
1/10dil.Cal(µL) - 10 10 20 50 100
Saline (µL) 100 150 70 60 50 -
Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
Quality Control
It is recommended to use Agappe protein control(11614003) to verify the
performance of the assay. Each laboratory has to establish its own internal quality
control scheme and procedure for corrective action, if controls do not recover with
in the acceptable tolerance.

ADL/V.01/APR 2012
IgG
Parameters Screen Calibration Screen
Test IgG Rule Spline
No Sensitivity
Full Name IgG Replicates 1
Standard No. 6 Interval ( day) 0
Reaction Type EP Difference Limit
Primary WL 670 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time -1 22 Determination Coeff. 0
Incubation Time 3 QC Screen
Unit mg/dL Control 1 *
Precision 0.1 Control 2 *
R1 180 µL
R2 180 µL
Sample 4 µL
R1 Blank
Mixed Rgt.Blank
Linearity Range 90 2700
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Reference Screen
Low *
High *
* Data entered by the operator

ADL/V.01/APR 2012
 1 x 30mL/1 x 10mL
IgA 12005035
INTENDED USE : This reagent is intended for in vitro quantitative determination of PERFORMANCE CHARACTERISTICS:
IgA antibodies, in serum. Measuring Range:- 1 –600 mg/dL.
-Turbidimetric Immuno assay If the concentration is greater than 600 mg/dL , dilute the sample with normal saline
-Linear up to 600 mg/dL and repeat the assay .Multiply the result with dilution factor.
-Multipoint calibration Prozone Effect:- >6000mg/dL
CLINICAL SIGNIFICANCE Precision in CV%:-
The measurement of IgA is important for typing immunodeficiencies and myelomas. Low Medium High
Further more it plays a role in acute and chronic infections as first line of defence. Intra - Run 0.84 0.94 1.20
Increased levels may be found in acute infectious hepatitis, chronic aggressive
hepatitis, cryptogenic cirrhosis, active alcoholic cirrhosis, chronic infections, Inter - Run 1.70 1.41 1.07
rheumatoid arthritis, mixed connective tissue diseases etc.
Interference:-
PRINCIPLE
No interference for
Antibodies to IgA are combined with IgA in the patient’s serum, forming immune
complexes. The immune complexes cause an increase in light scattering which Hemoglobin 1000 mg/dL
correlate with the concentration of IgA in the serum. The light scattering is Triglyceride 2500 mg/dL
measured by reading turbidity at 700 nm. Bilirubin 20mg /dL
REAGENT COMPOSITION BIBLIOGRAPHY
IgA R1(Buffer solution) 1 x 30 mL 1. K.Bergstorm, et al.: Scand. J. Clin. Lab. Invest., 637(1980)
Tris(hydroxymethyl)aminomethane 100 mmol/L 2. Rinsho Kensa Guide 1992, 269-274(1992) Published by BUNKODO CO., LTD
IgA R2(Antiserum solution) 1 x 10 mL 3. Kanai’s manual of Clinical laboratory Medicine, the 30 th edition,868-
873(1993)published by KANEHARA & CO.,LTD
Anti-human IgA antiserum

STORAGE AND STABILITY

The sealed reagents are stable upto the expiry date mentioned on the label when
stored at 2-8oC.
PRECAUTION
To avoid contamination, use clean laboratory wares, such as pipette tips and test
tubes. Close reagent bottle immediately after use. Avoid direct exposure of reagent
to light.
REFERENCE RANGE
It is recommended that , each laboratory should establish its own reference values.
The following values may be used as reference.
Serum : 110 - 410 mg/dL
SAMPLE
Use fresh Serum
CALIBRATION
Agappe Protein calibrator (11614002) is recommended for calibration of this assay.
Preparation of calibration curve:
Prepare the following calibrator dilutions using NaCl as diluent. Multiply the
concentration of the IgA calibrator by the corresponding factor stated in the table
below to obtain the IgA concentration of each dilution.
Dilution 1 2 3 4 5 6
Cali. (µL) - 10 10 20 50 100
Saline (µL) 100 150 70 60 50 -
Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
Quality Control
It is recommended to use Agappe protein control(11614003) to verify the
performance of the assay. Each laboratory has to establish its own internal quality
control scheme and procedure for corrective action, if controls do not recover with
in the acceptable tolerance.

ADL/V.01/APR 2012
IgA
Parameters Screen Calibration Screen
Test IgA Rule Spline
No Sensitivity
Full Name IgA Replicates 1
Standard No. 6 Interval ( day) 0
Reaction Type EP Difference Limit
Primary WL 670 SD
Sec. WL Blank Response
Direction Increasing Error Limit
Reaction Time -1 22 Determination Coeff. 0
Incubation Time 3 QC Screen
Unit mg/dL Control 1 *
Precision 0.1 Control 2 *
R1 210 µL
R2 70 µL
Sample 3 µL
R1 Blank
Mixed Rgt.Blank
Linearity Range 1 600
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Reference Screen
Low *
High *
* Data entered by the operator

ADL/V.01/APR 2012
 1 x 22mL/1 x 6.5mL
IgE 12005045
INTENDED USE : This reagent is intended for in vitro quantitative determination of PERFORMANCE CHARACTERISTICS:
IgE in human serum and plasma samples. Measuring Range:- 25 –1000 IU/mL.
-Latex enhanced Immunoturbidimetry If the concentration is greater than 1000 IU/mL , dilute the sample with normal saline
-Linearity up to 1000 IU/mL and repeat the assay .Multiply the result with dilution factor.
-Multipoint calibration Prozone Effect:- >50000IU/mL
CLINICAL SIGNIFICANCE Precision in CV%:-
IgE is an immunoglobulin with a molecular weight of approximately 190 KD. It is Low Medium High
normally present in the blood in trace amounts. IgE, like all immunoglobulins, is Intra - Run 1.18 0.36 0.82
produced by plasma cells in response to antigenic stimuli. However abnormal IgE levels
often results in the development of clinically important Type 1 allergic reactions such Inter - Run 4.56 1.88 1.21
as asthma, hay fever, dermatitis and food allergies. Elevated levels are also seen in cases Interference:-
of parasitic infections, pulmonary aspergillosis, Wiskott-Aldrich Syndrome, hepatitis No interference for
and myeloma.
Hemoglobin 1000 mg/dL
The measurement of IgE in human serum is thus considered to be useful in the
diagnosis, treatment, assessment of disease progression, or post-operative Triglyceride 2500 mg/dL
prognosis for such conditions. Bilirubin 20 mg /dL
PRINCIPLE BIBLIOGRAPHY
When an antigen-antibody reaction occurs between IgE and anti-IgE antibody which 1. Human neutrophils synthesize IL-8 in an IgE-mediated activation Monteseirin J
has been coated on latex particles, agglutination results. This agglutination is et al. J Leukoc Biol. 76: 692-700, 2004
detected as an absorbance change, with the magnitude of the change being 2. Myeloperoxidase release after allergen-specific conjunctival challenge
proportional to the quantity of IgE in the sample. The actual concentration is then Monteseirin J et al. J Asthma. 41: 639-643, 2004
determined by interpolation from a calibration curve prepared from calibrators of 3. IgE-dependent release of myeloperoxidase by neutrophils from allergic patients
known concentration. Monteseirin J et al. Clin Exp Allergy. 31 (6): 889-891, Jun 2001
REAGENT COMPOSITION
IgE R1 1 x 22mL
Glycine buffer solution
IgE R2 1 x 6.5 mL
Latex suspension
0.125 % w/v suspension of latex
particles sensitized with anti IgE
antibodies (mouse)

STORAGE AND STABILITY

The reagents are stable until expiry date when kept at 2-80 C
PRECAUTION
To avoid contamination, use clean laboratory wares. Use clean, dry disposable
pipette tips for dispensing. Close reagent bottles immediately after use. Avoid direct
exposure of reagent to light.
REFERENCE RANGE
It is recommended that each laboratory should establish its own reference values.
The following values may be used as guide line.
Normal value in Serum/ Plasma : up to 358 IU/mL
SAMPLE
Use Serum / Plasma
CALIBRATION
Agappe IgE calibrator is recommended for calibration of this assay.
Preparation of calibration curve:
Prepare the following calibrator dilution using NaCl as diluent. Multiply the
concentration of the IgE calibrator by the corresponding factors stated in the table
below to obtain the IgE concentration of each dilution.
Dilution 1 2 3 4 5 6
Cali. (µL) - 10 10 20 50 100
Saline (µL) 100 150 70 60 50 -
Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
Quality Control
It is recommended to use Agappe protein control(11614003) to verify the
performance of the assay. Each laboratory has to establish its own internal quality
control scheme and procedure for corrective action, if controls do not recover with
in the acceptable tolerance.

ADL/V.01/APR 2012
IgE
Parameters Screen Calibration Screen
Test IgE Rule Spline
No Sensitivity
Full Name IgE Replicates 1
Standard No. 6 Interval ( day)
Reaction Type FT Difference Limit
Primary WL 578 SD
Sec. WL 670 Blank Response
Direction Increase Error Limit
Reaction Time 1 9 Determination Coeff. 0
Incubation Time 3 QC Screen
Unit IU/mL Control 1
Precision 0.1 Control 2
R1 200µL
R2 50 µL
Sample 3 µL
R1 Blank 0
Mixed Rgt.Blank 0
Linearity Range 25 1000
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC Abs
Reference Screen
Low
High

ADL/V.01/APR 2012
 1 x 20mL/1 x 11mL
FERRITIN 12005044
INTENDED USE : The reagent is intended for in vitro quantitative determination of PERFORMANCE CHARACTERISTICS:
Ferritin in serum Measuring Range:- 10 –1000 ng/mL.
-Latex Enhanced Immunoturbidimetry If the concentration is greater than 1000 ng/mL , dilute the sample with normal saline
-High Linearity of 1000 ng/mL and repeat the assay .Multiply the result with dilution factor.
-Multipoint calibration Prozone Effect:- >30000ng/mL
CLINICAL SIGNIFICANCE Precision in CV%:-
Ferritin is an iron-containing protein. It is mainly found in liver and spleen, where Low High
its function is to eliminate and store iron in the body. It is also found in small Intra - Run 10 7
amounts in human serum. The serum levels tend to increase due to hepatitis and
malignant tumors. The measurement of ferritin is useful in diagnosis, treatment, Inter - Run 12 10
assessment of disease progression and post operative prognosis of abnormal iron Interference:-
metabolism and iron deficiency anaemia. No interference for
PRINCIPLE Hemoglobin 500mg/dL
Latex particles coated with anti-ferritin antibody are agglutinated when mixed with Triglyceride 3000 mg/dL
samples containing Ferritin. The agglutination causes an absorbance change which
depends on the Ferritin concentration in the sample, this can be interpolated using Bilirubin 30mg /dL
a calibration curve prepared from calibrators of different concentrations. Rheumatoid factor up to 560 IU/mL
REAGENT COMPOSITION BIBLIOGRAPHY
Ferritin - R1 1 x 20 mL 1. Cook, J.D., Lipschitz,D.A., Laughton, M.B.B., Miles, E.M. & Finch, C.A: Serum
Glycine buffer ferritin as a measure of iron stores in normal subjects. Am.J.clin.Nutr. 27: 680,
1974.
Ferritin - R2 1 x 11 mL 2. Walters,G.O.,Miller, F.M & Wormwood, M. : Serum ferritin concentration on
Suspension of latex particle bound to anti-ferritin antibodies and iron stores in normal subjects. J.clin.pathol. 26: 770-, 1973.

STORAGE AND STABILITY

The sealed reagents are stable upto the expiry date mentioned on the label when
stored at 2-8oC.
PRECAUTION
To avoid contamination, use clean laboratory wares, use clean dry disposable
pipette tips for dispensing, close reagent bottle immediately after use. Avoid direct
exposure of reagent to light.
NORMAL RANGE
It is recommended that, each laboratory should establish its own reference values.
The following value may be used as a guide line.
Male : 30 - 220 ng/mL
Females : 20 - 110 ng/mL
SAMPLE
Fresh Serum
CALIBRATION
Agappe Ferritin calibrator (11620002) is recommended for calibration of this assay.
Preparation of calibration curve:
Prepare the following calibrator dilutions using NaCl as diluent. Multiply the
concentration of the Ferritin calibrator by the corresponding factor stated in the table
below to obtain the Ferritin concentration of each dilution.
Dilution 1 2 3 4 5 6
Cali. (µL) - 10 10 20 50 100
Saline (µL) 100 150 70 60 50 -
Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
Quality Control
It is recommended to use Agappe protein control(11614003) to verify the
performance of the assay. Each laboratory has to establish its own internal quality
control scheme and procedure for corrective action, if controls do not recover with
in the acceptable tolerance.

ADL/V.01/APR 2012
FERRITIN
Parameters Screen Calibration Screen
Test Ferittin Rule Spline
No Sensitivity
Full Name Ferittin Replicates 1
Standard No. 5 Interval ( day) 0
Reaction Type EP Difference Limit
Primary WL 578 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time 0 30 Determination Coeff. 0
Incubation Time 3 QC Screen
Unit ng/L Control 1
Precision 0.1 Control 2
R1 180 µL
R2 90 µL
Sample 3 µL
R1 Blank
Mixed Rgt.Blank
Linearity Range 10 1000
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Refence Screen
Low
High

ADL/V.01/APR 2012
 1 x 23mL/1 x 5.5 mL
CYSTATIN-C 12005043
INTENDED USE: This reagent is intended for in vitro quantitative determination of Interference:-
Cystatin C in human serum. No interference for
-Latex enhanced Immunoturbidimetry Hemoglobin 500 mg/dL
-Linear of 10 mg/L Intrafat 1400 mg/dL
CLINICAL SIGNIFICANCE Bilirubin 25 mg /dL
Cystatin C is a low molecular weight (13 Da) cytoplasmic protein, functioning as an BIBLIOGRAPHY
inhibitor of various cystein protease in the blood stream. Cystatin C has a stable Filler G,.Bokenkamp A, Hofmann W, Le Bricon T, Martnez – Bru C, Grubb A
production rate and is removed from the blood circulation by glomerular filtration. Dharnidharka VR, Kwon Stevens G.
In healthy individuals Cystatin C is completely reabsorbed and degraded in the tubules
but in subject with renal disorders its level in blood may be raised as high as 2 to 5
times the normal values. Cystatin C is superior to serum creatinine as a marker of
glomerular filtration Rate.
PRINCIPLE
Cystatin C in the test sample binds to the specific polyclonal rabbit anti-Cystatin C
antibody, which has been adsorbed to latex particle and agglutinates. The
agglutination is detected as absorbance change at 546 nm. The magnitude of change
is proportional to the quantity of Cystatin C in the sample and its concentration is
determined by interpolation from a calibration curve prepared from calibrators of
known concentration.
REAGENT COMPOSITION
Cystatin C R1 1 x 23 mL
Tris buffer 1.2% (100 mM)
pH 8.5+0.3
Cystatin C R2 1 x 5.5 mL
Polystyrene latex particle coated with polyclonal anti Cystatin C antibody (rabbit)
Reagents required but not provided:
Cystatin C Calibrator (Product code -11623003)
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2- 80C.
PRECAUTIONS:
To avoid contamination, use clean laboratory wares, such as pipette tips and test
tubes. Close reagent bottle immediately after use. Avoid direct exposure of reagent
to light.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Individuals up to 50 years : 0.55 – 1.15 mg/L
Individuals above 50 years : 0.63 – 1.44 mg/L
SAMPLE
Required sample material is human serum or EDTA/ Heparinized plasma. It is
recommended to analyze the sample as fresh as possible.
CALIBRATION
Agappe Cystatin C calibrator is recommended for calibration of this assay.
Dilution of calibrator for calibration curve:
Calibration Curve (range between 0-10 mg/L). Prepare the following calibrator
dilution using NaCI as diluent. Multiply the concentration of the Cystatin C calibrator
by the corresponding factor stated in the table below to obtain the Cystatin C
concentration of each dilution.
Dilution 1 2 3 4 5 6
Cali. (µL) - 10 10 20 50 100
Saline (µL) 200 190 70 60 50 -
Dil. factor 0 0.05 0.125 0.25 0.5 1.0
PERFORMANCE CHARACTERISTICS:
Measuring Range:- 0.1 - 10 mg/L.
If the concentration is greater than 10 mg/L, dilute the sample with normal saline
and repeat the assay .Multiply the result with dilution factor.
Prozone Effect:- >60 mg/L
Precision :
MEAN INTRA RUN INTER RUN n
VALUE CV(%) CV(%)
Low human serum pool 0.77 2.16 2.54 20
High human serum pool 5.94 0.67 1.45 20
Medium human serum pool 1.45 1.58 1.95 20
Medium human serum pool 2.72 1.22 1.37 20
Low human serum pool 0.46 3.96 4.77 20
High human serum pool 3.82 1.81 3.05 20

ADL/V.01/APR 2012
CYSTATIN-C
Parameters Screen Calibration Screen
Test Cys - C Rule Spline
No Sensitivity
Full Name Cystatin -C Replicates 1
Standard No. 6 Interval ( day) 0
Reaction Type EP Difference Limit
Primary WL 546 SD
Sec. WL 670 Blank Response
Direction Increase Error Limit
Reaction Time 0 18 Determination Coeff. 0
Incubation Time 3 QC Screen
Unit mg/L Control 1
Precision 0.1 Control 2
R1 200 µL
R2 40 µL
Sample 3 µL
R1 Blank
Mixed Rgt.Blank
Linearity Range 0.1 10
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Reference Screen
Low
High

ADL/V.01/APR 2012
 1 x 30/1 x 9.5/1 x 0.5/2x63mL
HbA1c DIRECT 12005029
INTENDED USE: This reagent is intended for in vitro quantitative determination of Quality Control
HbA1c in human blood. It is recommended to use Agappe HbA1C Control level 1&2 (11604003) to verify
-Latex enhanced Immunoturbidimetry the performance of the assay. Each laboratory has to establish its own internal quality
-Multipoint calibration control scheme and procedure for corrective action, if controls do not recover with
-Direct result in % HbA1c from analyzer in the acceptable tolerance.
-No total Hb determination required PRECAUTION
CLINICAL SIGNIFICANCE To avoid contamination, use clean laboratory wares. Use clean, dry disposable
pipette tips for dispensing. Close reagent and standard bottles immediately after
HbA1c is a glycated form of haemoglobin formed by the attachment of glucose use.
residues in the blood to the hemoglobin molecules. In the diabetic population
where blood glucose levels are abnormally elevated the level of HbA1c also Avoid direct exposure of working reagent to light.
increases. The level of HbA1c is proportional to the level of glucose in the blood SAMPLE
and has been widely accepted as an indicator of the mean blood glucose Whole blood, collected with EDTA
concentration in the preceeding 6-8 weeks. It is therefore a long-term indicator of To determine HbA1c a heamolysate must be prepared for each sample
diabetic control. For routine use HbA1c levels should be monitored every 3-4 1. Dispense 1mL hemolysis reagent into a tube.
months. However in gestational diabetes and after a change in therapy it may be 2. Add 20 µL of well-mixed whole blood and mix.
useful to measure HbA1c more frequently at 2-4 week intervals. 3. Allow to stand for 5 minutes or until complete lysis is evident.
PRINCIPLE Follow the same procedure with calibrators and controls.
This method utilizes the interaction of antigen and antibody to directly determine INTERFERENCES
the HbA1c in whole blood. Total heomoglobin and HbA1c have the same No interference up to :
nonspecific absorption rate to latex particle. When mouse antihuman HbA1c Ascorbic acid 50 mg/dL
monoclonal antibodies are added (R2), latex HbA1c – mouse antihuman HbA1c
antibody complex is formed. Agglutination occurs when goat anti mouse IgG Bilirubin 50 mg/dL
polyclonal antibody interacts with the monoclonal antibody. The amount of Triglycerides 2000 mg/dL
agglutination is proportional to the amount of HbA1c absorbed onto the surface Carbamylated Hb 7.5 mmol/L
of latex particles. The amount of agglutination is measured as absorbance, which Acetylated Hb 5.0 mml/L
is used to calculate HbA1c % from a calibration curve. It has been reported that results may be inconsistent in patients who have the
REAGENT COMPOSITION following conditions: opiate addiction, lead poisoning, alcoholism, and ingestion of
HbA1c R1 1 x 30 mL large doses of aspirin. Elevated HbF levels may lead to under estimation of HbA1c.
Latex 0.13%(w/v) BIBLIOGRAPHY
Glycine buffer 20 mmol.L 1. Nathan, D.M., Clin, Chem. 29, pp.466-469 (1983)
HbA1c R2A 1 x 9.5 mL 2. Engbeak, F., et al. Clin chem.35 pp. 93-97 (1989)
Glycine buffer 80 mmol/L 3. American Diabetes Association : Clinical practice recommendations (position
statement). Diabetes care 24 (suppl.1) S33-S55, (2001).
HbA1c R2B 1 x 0.5 mL 4. Tietz, N.W. Textbook of Clinical Chemistry, W.B. Saunders Company,
Mouse anti-human HbA1c 10 mmol/L p.794 -7795 (1999).
Monoclonal antibody
Goat anti-mouse IgG 0.05 mg/dL
(Polyclonal)
Stabilizers 0.08 mg/dL
HbA1c R3 2x 63 mL
Haemolysis Reagent

STORAGE AND STABILITY

The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2- 80C, protected from light.
LINEARITY
The reagent is linear up to 16% (NGSP)
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
According NGSP :
<6% for non-diabetic
< 7% for glycemic control of person with diabetes
According to IFCC:
< 4.2% for a nion-diabetic
< 5.3% for glycemic control of a person with diabetes.
PREPARATION AND STABILITY OF WORKING REAGENT
Reagent 1 & Reagent 3 are ready to use.
Reagent R2 is prepared by pouring the entire contents of the R2B vial into the R2A
vial. Mix gently. This working reagent is stable for 30 days at 2-80C.
CALIBRATION
Agappe HbA1C Direct Multicalibrator ( 11604001) is recommended for calibration
of this assay. Reconstitute the calibrator with 0.5 mL distilled water and it will be
stable up to 30 days at 2-80C. Do not freeze.

ADL/V.01/APR 2012
HbA1c DIRECT
Parameters Screen Calibration Screen
Test HbA1C D Rule Spline
No Sensitivity
Full Name HbA1C Direct Replicates 1
Standard No. 5 Interval ( day) 0
Reaction Type Endpoint Difference Limit
Primary WL 630 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time -1 19 Determination Coeff. 0
Incubation Time 18 QC Screen
Unit % Control 1 *
Precision 0.01 Control 2 *
R1 210 µL
R2 75 µL
Sample 6 µL
R1 Blank
Mixed Rgt.Blank
Linearity Range 3 16
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Refence Screen
Low *
High *
* Data entered by the operator

ADL/V.01/APR 2012
 1 x 20/1 x 11 mL
ASO 12005040
INTENDED USE: This reagent is intended for in vitro quantitative determination of PERFORMANCE CHARACTERISTICS:
Anti Streptolysin – O (ASO). Measuring Range:- 20–800 IU/mL.
-Latex enhanced immunoturbidimetry If the concentration is greater than 800 IU/mL, dilute the sample with normal saline
-Linear up to 800 IU/mL. and repeat the assay. Multiply the result with dilution factor.
CLINICAL SIGNIFICANCE Prozone Effect:- >5600 IU/mL
ß-hemolytic streptococcus bacteria especially group A, C and G, produce an exotoxin Precision in CV%:-
known as Streptolysin-O. People infected with this bacterium produce an antibody Medium High
known as Anti Streptolysin-O (ASO). Measuring the levels of ASO is effective for
diagnosing, judging the progress of medical treatment and assessing the recovery Intra - Run 5.0 3.0
from diseases like rheumatic fever, acute glomerulonephritis and tonsillitis. Inter - Run 8 5
PRINCIPLE INTERFERENCES
When an antigen-antibody reaction occurs between ASO in the sample and Do not interfere for
streptolysin-O which has been sensitized to latex particles, agglutination occurs. This Hemoglobin up to 500 mg/dL
agglutination results in change of absorbance and is proportional to the quantity
of ASO in the sample. The actual concentration is determined by interpolation from Bilirubin up to 20 mg/dL
a calibration curve prepared from calibrators of known concentration. Intrafat up to 5000 mg/dL
REAGENT COMPOSITION BIBLIOGRAPHY
ASO R 1 1 x 20 mL 1. Galuin, J.P. et al.: Particle enhanced photometric immune assay system, Clin.
Glycine buffer solution Lab Assays (pap .Annu.clin.Lab.Assays Conf.)
2. Singer J.M. et al. The latex fixation test Application to the serologic diagnosis
ASO R2 1 x 11 mL or rheumatoid arthritis , Amer J.Med 21, 888(1956)
ASO Latex suspension particles coated with Streptolysin - O

STORAGE AND STABILITY

The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2- 80C.
PRECAUTION
To avoid contamination use clean laboratory wares. Use clean dry disposable pipette
tips for dispensing. Close reagent bottles immediately after use. Avoid direct
exposure of reagent to light.
NORMAL RANGE
It is recommended that each laboratory should establish its own reference values.
The following values may be used as guide line.
Serum
Adults : 200 IU/mL
children < 5 years : 100 IU/mL
CALIBRATION
Agappe ASO Calibrator ( Product code-11615002) is recommended for calibration
of this assay.
Quality Control
It is recommended to use Agappe protein control(11614003) to verify the
performance of the assay. Each laboratory has to establish its own internal quality
control scheme and procedure for corrective action, if controls do not recover with
in the acceptable tolerance.
SAMPLE
Fresh serum / plasma

ADL/V.01/APR 2012
ASO
Parameters Screen Calibration Screen
Test ASO Rule Spline
No Sensitivity
Full Name ASO Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type Endpoint Difference Limit
Primary WL 578 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time 0 15 Determination Coeff. 0
Incubation Time 10 QC Screen
Unit IU/mL Control 1
Precision 0.01 Control 2
R1 180µL
R2 90µL
Sample 3 µL
R1 Blank
Mixed Rgt.Blank
Linearity Range 20 800
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Reference Screen w

High

ADL/V.01/APR 2012
 1 x 20/1 x8 mL
CRP 12005041
INTENDED USE : This reagent is intended for in vitro quantitative determination of PERFORMANCE CHARACTERISTICS:
C-reactive protein in human serum or plasma by immunoturbidimetry. Measuring Range:- 1 –200 mg/L.
-Latex enhanced immunoturbidimetry If the concentration is greater than 200mg/L, dilute the sample with normal saline and
-Linear up to 200 mg/L repeat the assay. Multiply the result with dilution factor.
CLINICAL SIGNIFICANCE Prozone Effect:- >1000mg/L
CRP (C – reactive Protein) is a cytokine - induced, acute phase protein that Precision in CV%:-
increases in concentration as a result of inflammation. CRP levels in the body has Low Medium High
been used as a marker or indicator of infections and inflammation. The assay of
CRP is more sensitive than the erythrocyte sedimentation rate (ESR) and leukocyte Intra - Run 7.0 5.0 3.0
count. The CRP levels rise and return to reference ranges more rapidly after the Inter - Run 10 8 5
disease has subsided.
PRINCIPLE Interference:-
This is a latex enhanced turbidimetric immuno assay. CRP in the samples binds to No interference for
specific anti-CRP antibodies, which have been adsorbed to latex particles and Hemoglobin 500mg/dL
agglutinates. The agglutination is proportional to the quantity of CRP in the sample. Intrafat 500 mg/dL
The actual concentration is then determined by interpolation from a calibration Bilirubin 30mg /dL
curve prepared from calibrators of known concentrations. RF up to 500 IU/mL
REAGENT COMPOSITION BIBLIOGRAPHY
CRP R1 1 x 20 mL 1. Tillett.W.S..et al: Serological reactions in pneumonia with a non protein somatic
Glycine buffer fraction of pneumococcus.J.Exp.Med..52,561(1930).
CRP R2 1 x 8 mL 2. Zeigenhagen G,Drahovshy D.Klinishe Bedeutung des C-reaktiven protein.Medklin
Latex suspension coated with anti-CRP antibodies. (rabbit polyclonal antibody) 1983;78:45-50.
3. Rifal.N.Tracy.R.P.Ridker,P.M.Clinical efficacy of an Automated High sensitivity C
Reactive protein Assay..45-12.

STORAGE AND STABILITY

The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2-8oC.
PRECAUTION
To avoid contamination, use clean laboratory wares. Avoid direct exposure of
reagent to light.
The reagent should be used according to this pack insert. If used otherwise,
appropriate performance is not guaranteed.
NORMAL RANGE
It is recommended that each laboratory should establish its own reference values.
The following value may be used as a guide line.
Serum up to 6 mg/L
SAMPLE
Fresh serum (Do not use hemolized or lipemic serum)
CALIBRATION
Agappe CRP Calibrator ( 11616002) is recommended for calibration of this assay.
Preparation of calibration curve:
Prepare the following calibrator dilutions using NaCl as diluent. Multiply the
concentration of the CRP calibrator by the corresponding factor stated in the table
below to obtain the CRP concentration of each dilution.
Dilution 1 2 3 4 5 6
Cali. (µL) - 10 10 20 50 100
Saline (µL) 100 150 70 60 50 -
Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
Quality Control
It is recommended to use Agappe protein control(11614003) to verify the
performance of the assay. Each laboratory has to establish its own internal quality
control scheme and procedure for corrective action, if controls do not recover with
in the acceptable tolerance.

ADL/V.01/APR 2012
CRP
Parameters Screen Calibration Screen
Test CRP LEIT Rule Spline
No Sensitivity
Full Name CRP LEIT Replicates 1
Standard No. 6 Interval ( day) 0
Reaction Type Endpoint Difference Limit
Primary WL 578 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time 0 15 Determination Coeff. 0
Incubation Time 10 QC Screen
Unit mg/L Control 1
Precision 0.01 Control 2
R1 210 µL
R2 70 µL
Sample 3 µL
R1 Blank
Mixed Rgt.Blank
Linearity Range 1 200
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Reference Screen w

High

ADL/V.01/APR 2012
 1x 20/1 x 8 mL
RF 12005048
INTENDED USE: This reagent is intended for in vitro quantitative determination of PERFORMANCE CHARACTERISTICS:
Rheumatoid factor in Serum. Measuring Range:- 10 - 135 IU/mL.
-Latex enhanced immunoturbidimetry If the concentration is greater than 135 IU/mL, dilute the sample with normal saline
-Linear upto 135 IU/mL and repeat the assay .Multiply the result with dilution factor.
CLINICAL SIGNIFICANCE Prozone Effect:- >770 IU/mL
Rheumatoid Factor (RF) is an auto antibody against human IgG commonly seen in Precision in CV%:-
sera, particularly in patients with rheumatoid arthritis. The measurement of RF value Low High
is useful in evaluating the diagnosis, effects of therapy and prognosis of RA, systemic
lupus erythematosus, Chronic hepatopathy etc. Intra - Run 5.0 1.0
PRINCIPLE Inter - Run 8.0 5.0
When a sample containing rheumatoid factor is added to denatured human IgG Interference:-
which has been sensitizied to latex particles, antigen-antibody reaction occurs
leading to agglutination. This agglutination leads to an absorbance change which No interference for
is measured at (550 to 660nm). The change in absorbance is proportional to Hemoglobin 500mg/dL
agglutination and the actual concentration is determined by interpolation from a Intrafat 5000mg/dL
calibration curve prepared from known value calibrators. Bilirubin 20mg /dL
REAGENT COMPOSITION BIBLIOGRAPHY
RF R 1 1 x 20 mL Frederick Wolfe et al-Arthritis and Rheumatism 1991 : 34:951-960
Glycine Buffer Solution
RF R2 1 x 8 mL
Latex suspension coated with denatured human IgG

STORAGE AND STABILITY

The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2- 80C.
PRECAUTION
To avoid contamination, use clean laboratory wares. Avoid direct exposure of
reagent to light & heat.
The reagent should be used according to this pack insert. If used otherwise,
appropriate performance is not guaranteed.
NORMAL RANGE
It is recommended that each laboratory should establish its own reference values.
The following value may be used as guide line.
Serum up to 18 IU/mL
SAMPLE
Fresh serum (Do not use haemolized or lipemic serum)
CALIBRATION
Agappe RF Calibrator ( Product code-11617002)) is recommended for calibration
of this assay.
Preparation of calibration curve:
Prepare the following calibrator dilutions using NaCl as diluent. Multiply the
concentration of the RF calibrator by the corresponding factor stated in the table
below to obtain the RF concentration of each dilution.
Dilution 1 2 3 4 5 6
Cali. (µL) - 10 20 50 75 100
Saline (µL) 100 70 60 50 25 -
Dil. factor 0 0.125 0.25 0.5 0.75 1.0
Quality Control
It is recommended to use Agappe protein control(11614003) to verify the
performance of the assay. Each laboratory has to establish its own internal quality
control scheme and procedure for corrective action, if controls do not recover with
in the acceptable tolerance.

ADL/V.01/APR 2012
RF
Parameters Screen Calibration Screen
Test RF Rule Spline
No Sensitivity
Full Name RF Replicates 1
Standard No. 6 Interval ( day) 0
Reaction Type Endpoint Difference Limit
Primary WL 578 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time 0 15 Determination Coeff. 0
Incubation Time 10 QC Screen
Unit IU/dL Control 1
Precision 0.01 Control 2
R1 210 µL
R2 70 µL
Sample 6 µL
R1 Blank
Mixed Rgt.Blank
Linearity Range 10 135
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Refence Screen
Low
High

ADL/V.01/APR 2012
 1 x 23/1 x 5.5 mL
Lp (a) 12005046
INTENDED USE: This reagent is intended for in vitro quantitative determination of
Lipoprotein (a) in serum.
-Multipoint calibration with fixed time mode
-Linearity up to 80 mg/dL
CLINICAL SIGNIFICANCE
Lp(a) is a low density lipoprotein like particle containing apoliprotein B-100
disulphide-linked to one large glycoprotein called apoliprotein(a). Many investigators
have confirmed that a high lipoprotein(a) concentration represents an indicator of
risk for cardio vascular diseases, especially when, the serum LDL-cholesterol or apo
B are elevated. The quantification of Lp (a) in serum or plasma is important for
identification of individuals at risk for developing artherosclerosis.
PRINCIPLE
Latex particles coated with anti-human Lp(a) are agglutinated when mixed with
samples containing Lp(a). The agglutination causes an absorbance change
dependent upon the Lp(a) contents of the patient sample, that can be interpolated
in a calibration curve prepared with different calibrators of different Lp(a) contents.
REAGENT COMPOSITION
LIPOPROTEIN (a) R1 1 x 23 mL
Buffer solution (pH 8.3)
LIPOPROTEIN (a) R2 1 x 5.5 mL
Lipoprotein (a) latex
Reagents required but not provided:
Lp(a) Calibrator ( Product code-11619002)
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2- 80C.
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of working reagent to light.
NORMAL RANGE
It is recommended that each laboratory should establish its own reference values.
The following value may be used as guide line.
Serum up to 30 mg/dL
SAMPLE
Fresh Serum sample (free of haemolysis)
CALIBRATION
Agappe Lp(a) Calibrator ( 11619002) is recommended for calibration of this assay.
Calibration curve : Prepare dilutions of the Lp(a) calibrator using 9 g/L saline as
diluent:
Dilution 1 2 3 4 5
Cali. (µL) - 25 50 75 100
Saline (µL) 100 75 50 25 -
Dil. factor 0 0.25 0.5 0.75 1.0
Multiply the Lp(a) calibrator concentration by the corresponding dilution factor
indicated in the table to obtain the Lp(a) concentration of the different (diluted)
calibrators.
PERFORMANCE CHARACTERISTICS
1. Measurement Range: 12-80mg/dL
If the concentration is greater than linearity (80mg/dL), dilute the sample and
repeat the assay. Multiply the result with dilution factor.
2. Prozone effect: No prozone effect was detected up to 225 mg/dL.
INTERFERENCES
Bilirubin : up to 427 mmol/L no interference
Hemoglobin : up to 10 g/L no interference
Lipids : up to 5 g/L no interference
BIBLIOGRAPHY
1. Gaubalz JW, et al. J.Biol Chem 1983; 258 45832 -4589
2. Berg K A Acta Pathol Microbiol Scand 1963:59:369-382
3. Scanu AM , et al. J.Clin invest 1990;85: 1709 -1715

ADL/V.01/APR 2012
Lp (a)
Parameters Screen Calibration Screen
Test LP(a) LEIT Rule Spline
No Sensitivity
Full Name LP(a) LEIT Replicates 1
Standard No. 6 Interval ( day) 0
Reaction Type EP Difference Limit
Primary WL 670 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time 0 18 Determination Coeff. 0
Incubation Time 3 QC Screen
Unit mg/dL Control 1 *
Precision 0.1 Control 2 *
R1 200 µL
R2 40 µL
Sample 3 µL
R1 Blank
Mixed Rgt.Blank
Linearity Range 12 80
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Refence Screen
Low *
High *
* Data entered by the operator

ADL/V.01/APR 2012
 1 x 23/1 x 5.5 mL
MICROALBUMIN 12005047
INTENDED USE: This reagent is intended for in vitro quantitative determination of PERFORMANCE CHARACTERISTICS:
microalbumin in human urine Measuring Range:- 4 - 395 mg/L
-Turbidometric Immunoassay If the concentration is greater than linearity (395 mg/L), dilute the sample with normal
-Linear up to 395 mg/L saline and repeat the assay. Multiply the result with dilution factor.
-Multipoint calibration Prozone Effect:- >6000 mg/L
CLINICAL SIGNIFICANCE Precision in CV%:-
Albumin is normally found in the blood. When the kidneys are working properly, Low Medium High
albumin will not be present in the urine. However, when the kidneys are damaged, Intra - Run 2.28 1.8 3.04
small amounts of albumin leak into the urine. This condition is called
microalbuminuria. Inter - Run 2.93 0.66 0.53
Microalbuminuria is most often caused by kidney damage from diabetes. However, Interference:-
many other conditions can lead to kidney damage, such as high blood pressure,
heart failure, cirrhosis, or systemic lupus erythematosus (SLE). If early kidney No interference for
damage is not treated, larger amounts of albumin and protein may leak into the Hemoglobin 1000mg/dl
urine. This condition is called macroalbuminuria or proteinuria, this can lead to Bilirubin 10mg/dL
chronic kidney disease. BIBLIOGRAPHY
PRINCIPLE 1. Mount,J., J. Clin. Pathology, 22, 12 (1986)
The reagents containing polyclonal goat antihuman microalbumin when mixed with 2. Schmidtz, A., et al., diabetic Medicine, 5 , 126 (1988)
the urine sample containing microalbumin cause changes in absorbance, due to
the development of turbidity, which is directly proportional to the concentration
of microalbumin in the sample.
REAGENT COMPOSITION
Microalbumin R1 1 x 23 mL
Saline (9 g/L)
Accelerator
Sodium azide (0.95 g/L)
Microalbumin R2 1 x 5.5 mL
Phosphate buffered saline
Polyclonal goat anti-human albumin (variable)
Sodium azide (0.95 g/L)

STORAGE AND STABILITY

The reagents are stable until expiry date when kept at 2-80 C.
PRECAUTION
To avoid contamination, use clean laboratory materials. Use clean, dry disposable
pipette tips for dispensing. Close reagent bottles immediately after use. Avoid direct
exposure of reagent to light. Do not Freeze.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following values may be used as guide line.
Urine : 0 -25 mg/L (IFCC)
SAMPLE
Use fresh Urine.
CALIBRATION
Agappe Microalbumin Calibrator ( Product code-11618002) is recommended for
calibration of this assay.
PREPARATION OF CALIBRATION CURVE
Prepare the following calibrator dilutions using NaCl as diluent. Multiply the
concentration of the microalbumin calibrator by the corresponding factor stated in
the table below to obtain the microalbumin concentration of each dilution.

Dilution 1 2 3 4 5 6
Calib.(µL) - 10 10 25 50 100
Saline(µL) 100 150 70 75 50 -
Dil. Factor(µL) 0 0.0625 0.125 0.25 0.5 1.0

ADL/V.01/APR 2012
MICROALBUMIN
Parameters Screen Calibration Screen
Test MicroAlb Rule Spline
No Sensitivity
Full Name Micro Albumin Replicates 1
Standard No. 6 Interval ( day) 0
Reaction Type Fixed time Difference Limit
Primary WL 340 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time -1 22 Determination Coeff. 0
Incubation Time 20 QC Screen
Unit mg/L Control 1
Precision 0.01 Control 2
R1 200 µL
R2 40 µL
Sample 3 µL
R1 Blank
Mixed Rgt.Blank
Linearity Range 4 395
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Refence Screen
Low
High

ADL/V.01/APR 2012
 1x20 / 1x11 mL
CRP Ultra 12005042
INTENDED USE: This reagent is intended for in vitro quantitative determination of PERFORMANCE CHARACTERISTICS:
C-reactive protein (CRP) in serum. Measuring Range:- 0.13 – 10mg/L.
-Latex Enhanced Immuno Turbidimetric assay Prozone Effect:- >1000mg/L
-Sensitivity of 0.13 mg/L Precision in CV%:-
-Linearity up to 10 mg/L Low Medium High
CLINICAL SIGNIFICANCE Intra - Run 7 5 3
CRP is an acute phase protein produced by liver. It’s level will rise in response to
inflammations and infections. Inter - Run 10 8 5
Inflammation of arteries is a risk factor for cardiovascular disease. It is linked to an INTERFERING SUBSTANCES
increased risk of heart disease, heart attack, stroke and peripheral arterial disease. Test will not be affected by:
CRP ultra/HS CRP is the strongest predictor of cardiac risk. The value more than 10 Hemoglobin up to 500 mg/dL
mg/L cannot be considered for cardiac risk factors. Conjugated Bilirubin up to 30 mg/dL
Routinely available CRP methods are to determine infections or chronic Intra Fat up to 500 mg/dL
inflammatory disease where CRP concentration is above 10 mg/L. These methods
are with limited sensitivity hence it cannot precisely measure CRP concentrations Rheumatoid Factor up to 500 IU/mL
below 10 mg/L. BIBLIOGRAPHY
Studies have shown that measuring CRP with improved methodology of high 1. Claus DR,Osmand AP, Gewurz H. Radioimmunoassay of human C-reactive
sensitive assay can identify the risk level of CVD in apparently healthy people. protein and levels in normal sera. J Lab Clin Med 1976;87: 120-128
Relatively high levels of hs CRP in healthy individuals are predictive of the future 2. Wasunna A, Whitelaw A,Gallimore R,Hawkins PN,Pepys MB. C-reactive protein
risk of heart disease even when cholesterol levels are within the acceptable range. and bacterial infection in preterm infants. Eur J Pediatr 1990; 149: 424-427
PRINCIPLE
This is a latex-enhanced turbidimetric invitro immuno assay. CRP in the sample binds
to specific anti-CRP antibodies, which had been adsorbed to latex particles and
agglutinates. The agglutination is detected as an absorbance change. The magnitude
of the change is proportional to the concentration of CRP in the sample. The actual
concentration is then detected by interpolation from a calibration curve prepared
from calibrators of known concentration.
REAGENT COMPOSITION
CRP Ultra R1 1 x 20 mL
Glycine buffer
CRP Ultra R2 1 x 11 mL
Latex suspension coated with anti-CRP antibodies. (Rabbit polyclonal antibody)

STORAGE AND STABILITY

The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2-80C. Stability in the instrument is at least 4 weeks if contamination is avoided.
Do not freeze.
PRECAUTION
To avoid contamination, use clean laboratory wares. Use clean, dry disposable
pipette tips for dispensing. Close reagent bottles immediately after use.
Avoid direct exposure of reagent to light. Do not blow into the reagent bottles.
REFERENCE RANGE
It is recommended that each laboratory should establish its own reference values.
The following value may be used as guide line.
Less than 1 mg/L = Low risk for CVD
1.0-2.9 mg/L = Intermediate Risk for CVD
Greater than 3 mg/L = High Risk for CVD
SAMPLE
Fresh serum (free of haemolysis)
CALIBRATION
Agappe CRP Ultra calibrator is recommended for calibration of this assay.
PREPARATION OF CALIBRATION CURVE
Prepare the following calibrator dilution using NaCl as diluent. Multiply the
concentration of the CRP ultra calibrator by the corresponding factors stated in the
table below to obtain the CRP ultra concentration of each dilution.
Dilution 1 2 3 4 5 6
Calib.(µL) - 10 10 20 50 100
Saline(µL) 100 150 70 60 50 -
Dil. Factor 0 0.0625 0.125 0.25 0.5 1.0

ADL/V.01/APR 2012
CRP Ultra
Parameters Screen Calibration Screen
Test CRP Rule Spline
No Sensitivity
Full Name CRP Replicates 1
Standard No. 6 Interval ( day) 0
Reaction Type Endpoint Difference Limit
Primary WL 578 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time 0 15 Determination Coeff. 0
Incubation Time 10 QC Screen
Unit mg/L Control 1
Precision 0.01 Control 2
R1 180 µL
R2 90 µL
Sample 3 µL
R1 Blank
Mixed Rgt.Blank
Linearity Range 0.13 10
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Refence Screen
Low
High

ADL/V.01/APR 2012
SyRe - BS120/200 - Updated

ADL/V.01/APR 2012
 4 x 30 mL
ALBUMIN 12005001
INTENDED USE
This reagent is intended for in vitro quantitative determination of Albumin in serum
or plasma.
-Bromocresol green methodology
-Linear up to 6 g/dL
CLINICAL SIGNIFICANCE
Albumin which is synthesized in the liver constitutes a major part of the total
proteins in the body, the other part being globulin; they form the major portion of
the dissolved substances in the plasma. Functions of Albumin includes distribution
of extracellular fluid, regulation of osmotic pressure, acts as transport agent for a
wide variety of substance such as hormones lipids, vitamins etc.
Increased levels are seen in dehydration.
Decreased levels are seen in liver disease (Hepatitis, Cirrhosis), malnutrition, kidney
disorders, increased fluid loss during extensive burn & malabsorption.
PRINCIPLE
The reaction between albumin from serum or plasma and the dye bromocresol-
green produces a change in colour that is proportional to the albumin concentration
REAGENT COMPOSITION
ALBUMIN REAGENT 4 x 30 mL
Succinate Buffer (pH 4.20) 75 mmol/L
Bromocresol green 0.14 g/L
Reagents Required But not Provided
Multi Calibrator ( Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at room temperature.
LINEARITY
This reagent is linear upto 6 g/dL
If the concentration is greater than linearity (6 g/dL), dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum/plasma – 3.5 – 5.5 g/dL
CALIBRATION
Agappe Multicalibrator( Product Code No - 11610001)is recommended for
calibration .
Quality Control – It is recommended to use Qualicheck Norm (Code No. 11601003)
or Qualicheck path (Code No. 11601002) to verify the performance of the
measurement procedure.
Each Laboratory has to establish its own internal quality control scheme and
procedures for corrective action if controls do not recover within the acceptable
tolerance.
BIBLIOGRAPHY
1. Doumasa B.T.etal: Clin. Chim Acta 31, 87 pp (1971)
2. Weis, W.A. :Klin. Wochenschr. 43, S.273 (1965)

ADL/V.01/APR 2012
Albumin
Parameters Screen Calibration Screen
Test ALB Rule Two Point Linear
No Sensitivity
Full Name Albumin Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type End Point Difference Limit
Primary WL 630 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time 0 15 Determination Coeff. 0
Incubation Time QC Screen
Unit g/dL Control 1 *
Precision 0.1 Control 2 *
R1 250 µL
R2 0
Sample 3 µL
R1 Blank 0 3000
Mixed Rgt.Blank
Linearity Range 0 6
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Reference Screen
Low *
High *

ADL/V.01/APR 2012
 2 x 30 / 2 x 8 mL
ALKALINE PHOSPHATASE 12005002
INTENDED USE
This reagent is intended for in vitro quantitative determination of Alkaline
Phosphatase in serum or plasma.
-DGKC – SCE recommended procedure .
-Linear up to 700 U/L
CLINICAL SIGNIFICANCE
Alkaline phosphatase is widely distributed throughout the body, but clinically
important one for diagnostic reasons are in bone, liver, placenta & intestine.
Growing bone is associated with the release of ALP and so in childhood the level
of ALP is around 3 times of that of adult. During pregnancy in 2nd & 3rd trimester
the enzyme rises considerably due to placenta releasing ALP. It can be used to
examine placental function.
Elevated levels are seen in bone diseases, e.g. Paget’s disease, Rickets, Osteoblastic
metastatic & in obstructive disease of biliary tract.
Decreased levels are rarely seen. e.g. in Vitamin A resistant rickets.
ALP = Alkaline Phophatase
PRINCIPLE
Kinetic determination of Alkaline Phosphatase(ALP) is based upon the following
reaction.
ALP
Para nitrophenyl phosphate + H2O ------------> p-nitrophenol+Inorganic phosphate
ALP = Alkaline Phosphatase
REAGENT COMPOSITION
ALKALINE PHOSPHATASE R1 2 x 30 mL
Diethanolamine Buffer,(pH10.2) 125 mmol/L
Magnesium Chloride 0.625mmol/L
ALKALINE PHOSPHATASE R2 2 x 8 mL
P-Nitrophenyl phosphate 50 mmol /L
REAGENTS REQUIRED BUT NOT PROVIDED
Multi Calibrator (Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2-80C.
LINEARITY
The reagent is linear, up to 700 U/L
If the concentration is greater than linearity (700 U/L), dilute the sample with
normal saline & repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values. The
following value may be used as guideline.
Women 64 – 306 U/L
Men 80 – 306 U/L
Children up to 15yrs < 644 U/L
PRECAUTION
To avoid contamination use clean laboratory wares.
Avoid direct exposure of working reagent to light.
SAMPLE
Fresh serum/plasma (free of haemolysis)
CALIBRATION
Agappe Multicalibrator( Product Code No - 11610001)is recommended for
calibration .
Quality Control – It is recommended to use Qualicheck Norm (Code No. 11601003)
or Qualicheck path (Code No. 11601002) to verify the performance of the
measurement procedure.
Each Laboratory has to establish it’s own internal quality control scheme and
procedures for corrective action if controls do not recover within the acceptable
tolerance.
BIBLIOGRAPHY
1. Schlebush, H.et al.,Dtsh.med.Wschr.99,765(1974)
2. Z.Klin. Chem.,Klin. Biochem.8,658(1980)10,182(1972)

ADL/V.01/APR 2012
ALKALINE PHOSPHATASE
Parameters Screen Calibration Screen
Test ALP Rule Two Point Linear
No Sensitivity
Full Name Alk. Phosphatase Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type Kinetic Difference Limit
Primary WL 405 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time 4 12 Determination Coeff. 0
Incubation Time 10 QC Screen
Unit U/L Control 1
Precision 0.1 Control 2
R1 200 µL
R2 50 µL
Sample 5 µL
R1 Blank 0 10000
Mixed Rgt.Blank
Linearity Range 0 700
Linearity Limit 0.2
Substrate Limit 13000
Factor
Prozone chek
q1 q2 q3 q4
PC
Reference Screen
Low
High

ADL/V.01/APR 2012
 2 x 30 mL
AMYLASE 12005003
INTENDED USE
This reagent is intended for in vitro quantitative determination of Amylase in serum,
plasma & urine.
-CNPG3 methodology.
-Linear up to 2000 U/L
CLINICAL SIGNIFICANCE
Amylase occurs in the salivary glands, fallopian tubes & in pancreas.
a -amylase is secreted by the pancreas from where it enters the duodenum, through
the pancreatic duct. Any obstruction to these ducts causes
a-amylase enzyme to enter the blood stream.
Elevated levels are seen in acute pancreatitis, peptic ulcers, biliary disease, parotitis
& other intestinal obstructions.
Decreased levels are seen in chronic pancreatic disorders having pancreatic cell
destruction.
PRINCIPLE
Amylase
5CNPG3 -------------> 3 CNP +2CNPG2+3 Maltotriose + 2 Glucose.
CNP : Chloro-4-nitrophenol
CNP-G2 : 2-chloro -4-nitrophenyl-a maltoside
REAGENT COMPOSITION
ALPHA AMYLASE (S.L) R1 2 x 30 mL
MES Buffer (pH6.0) 50mmol/L
CNPG3 2.27 mmol/L
Calcium chloride 60 mmol/L
Sodium chloride 70 mmol/L
Activator 900 mmol/L
REAGENTS REQUIRED BUT NOT PROVIDED
Multi Calibrator (Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2-80C.
LINEARITY
The reagent is linear, up to 2000 U/L
If the concentration is greater than linearity (2000 U/L), dilute the sample with
normal saline & repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values. The
following value may be used as guide line.
Serum , plasma 25-86 U/L
Urine < 470 U/L
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
This reagent is very sensitive to external contamination, ie Saliva, Sweat etc which
contains a-amylase. Handle with gloves & keep vial tightly sealed after use.
Discard reagent if it turns cloudy.
SAMPLE
Fresh serum, plasma (free of haemolysis)
Urine (1/3 diluted)
CALIBRATION
Agappe Multicalibrator( Product Code No - 11610001)is recommended for
calibration .
Quality Control – It is recommended to use Qualicheck Norm (Code No. 11601003)
or Qualicheck path (Code No. 11601002) to verify the performance of the
measurement procedure.
Each Laboratory has to establish its own internal quality control scheme and
procedures for corrective action if controls do not recover within the acceptable
tolerance.
BIBLIOGRAPHY
1. Junge, W. et al., Clin. Biochem. 22, 109(1989)
2. Hohenwallnern, W., J.Clin. chem.. Clin. Biochem. 27,97(1989)

ADL/V.01/APR 2012
AMYLASE
Parameters Screen Calibration Screen
Test Amy Rule Two Point Linear
No Sensitivity
Full Name Amylase Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type Kinetic Difference Limit
Primary WL 405 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time 4 12 Determination Coeff. 0
Incubation Time QC Screen
Unit U/L Control 1
Precision 0.1 Control 2
R1 200 µL
R2 0
Sample 5 µL
R1 Blank 0 2000
Mixed Rgt.Blank
Linearity Range 0 2000
Linearity Limit 0.2
Substrate Limit 18000
Factor
Prozone chek
q1 q2 q3 q4
PC
Reference Screen
Low
High

ADL/V.01/APR 2012
 4 x 30 / 2 x 8 mL
BILIRUBIN DIRECT 12005004
INTENDED USE
This reagent is intended for in vitro quantitative determination of Bilirubin in serum
or plasma .
-Linear up to 20 mg/dL
CLINICAL SIGNIFICANCE
Bilirubin is formed by the breakdown of RBC’s in the spleen, liver & bone marrow.
Small amount of bilirubin circulates in the plasma loosely bound to albumin, which
is not water soluble. This is referred to as indirect or unconjugated bilirubin. In the
liver bilirubin is conjugated with glucuronic acid, which forms a soluble compound.
This is referred to a direct bilirubin.
Elevated levels are found in Hepatitis, Cirrhosis, Haemolytic jaundice, obstruction
of biliary tract & drug induced reactions.
PRINCIPLE
Sulfanilic acid reacts with sodium nitrite to form diazotized sulfanilic acid. Direct
Bilirubin reacts with diazotized sulfanic acid to form azobilirubin.
REAGENT COMPOSITION
DIRECT BILIRUBIN REAGENT 4 x 30 mL
Sulfanilic acid 28.9 mmol/L
Hydrochloric acid 165 mmol/L
Preservatives and stabilizers
DIRECT BILIRUBIN ACTIVATOR 2 x 8 mL
REAGENTS REQUIRED BUT NOT PROVIDED
Multi Calibrator ( Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at RT. Activator should be stored at 2 - 80C
LINEARITY
This reagent is linear up to 20 mg/dL.
If the concentration is greater than linearity (20 mg/dL), dilute the sample with
normal saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Direct Bilirubin - up to 0.4 mg/dL
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
SAMPLE
Serum / plasma (free of haemolysis)
CALIBRATION
Agappe Multicalibrator( Product Code No - 11610001)is recommended for
calibration .
Quality Control – It is recommended to use Qualicheck Norm (Code No. 11601003)
or Qualicheck path (Code No. 11601002) to verify the performance of the
measurement procedure.
Each Laboratory has to establish its own internal quality control scheme and
procedures for corrective action if controls do not recover within the acceptable
tolerance.
BIBLIOGRAPHY
1. Water M., Gerard H.: MICROCHEM JM 15, 231(1980)
2. Annino J. S.: C.C. Principles and procedure,1960
3. A.A. A.C.C.: Clin Chem 8 : 405,196

ADL/V.01/APR 2012
BILIRUBIN DIRECT
Parameters Screen Calibration Screen
Test Bili D Rule Two Point Linear
No Sensitivity
Full Name Bilirubin Direct Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type End Point Difference Limit
Primary WL 546 SD
Sec. WL 630 Blank Response
Direction Increase Error Limit
Reaction Time -1 20 Determination Coeff. 0
Incubation Time 10 QC Screen
Unit mg/dL Control 1
Precision 0.1 Control 2
R1 300 µL
R2 35 µL
Sample 15 µL
R1 Blank 0 1000
Mixed Rgt.Blank 0 1200
Linearity Range 0 24
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC Abs
Reference Screen
Low
High

ADL/V.01/APR 2012
 4 x 35 / 2 x 10 mL
BILIRUBIN TOTAL (TAB) 12005005
INTENDED USE
This reagent is intended for in vitro quantitative determination of Bilirubin in serum
or plasma
-Modified TAB method
-Linear up to 25 mg/dL
CLINICAL SIGNIFICANCE
Bilirubin is formed by the breakdown of RBCs in the spleen, liver & bone marrow.
Small amount of bilirubin circulates in the plasma loosely bound to albumin, which
is not water soluble. This is referred to as indirect or unconjugated bilirubin. In the
liver bilirubin is conjugated with glucuronic acid, which forms a soluble compound.
This is referred to as direct bilirubin.
Elevated levels are found in Hepatitis, Cirrhosis, Haemolytic jaundice, obstruction
of biliary tract & drug induced reactions.
PRINCIPLE
Sulfanilic acid reacts with sodium nitrite to form diazotized sulfanilic acid. Total
Bilirubin reacts with diazotized sulfanilic acid in the presence of TAB to form
azobilirubin.
REAGENT COMPOSITION
TOTAL BILIRUBIN REAGENT 4 x 35 mL
Sulfanilic acid 28.9 mmol/L
TAB 9 mmol/L
Preservatives and Stabilizers
TOTAL BILIRUBIN ACTIVATOR 2 x 10 mL
REAGENTS REQUIRED BUT NOT PROVIDED
Multi Calibrator ( Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at RT. Activator should be stored at 2 - 80C
LINEARITY
This reagent is linear up to 25 mg/dL.
If the concentration is greater than linearity (25 mg/dL), dilute the sample with
normal saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Total Bilirubin - up to 1.2 mg/dL
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
SAMPLE
Serum/Plasma (free of haemolysis)
CALIBRATION
Agappe Multicalibrator( Product Code No - 11610001)is recommended for
calibration .
Quality Control – It is recommended to use Qualicheck Norm (Code No. 11601003)
or Qualicheck path (Code No. 11601002) to verify the performance of the
measurement procedure.
Each Laboratory has to establish its own internal quality control scheme and
procedures for corrective action if controls do not recover within the acceptable
tolerance.
BIBLIOGRAPHY
1. Walter M., Gerard H.: MICROCHEM JM 15, 231.(1980)
2. Annino J. S.: C.C. Principles and procedure,1960
3. A.A. A.C.C.: Clin Chem 8 : 405,196

ADL/V.01/APR 2012
BILIRUBIN TOTAL
Parameters Screen Calibration Screen
Test Bili T Rule Two Point Linear
No Sensitivity
Full Name Bilirubin Total Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type End Point Difference Limit
Primary WL 546 SD
Sec. WL 630 Blank Response
Direction Increase Error Limit
Reaction Time -1 20 Determination Coeff. 0
Incubation Time 10 QC Screen
Unit mg/dL Control 1
Precision 0.1 Control 2
R1 300 µL
R2 35 µL
Sample 15 µL
R1 Blank 0 1000
Mixed Rgt.Blank 0 2000
Linearity Range 0 25
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC Abs
Reference Screen
Low
High

ADL/V.01/APR 2012
 2 x 35 mL
CALCIUM (ARSENAZO) 12005006
INTENDED USE
This reagent is intended for in vitro quantitative determination of Calcium in serum,
plasma & urine.
-Modified Arsenazo III method
-Linear up to 16 mg/dL
CLINICAL SIGNIFICANCE
Calcium is an important ion present in the body. Mainly it is found in bones. In serum
calcium exists equally in a free ionized form & also in a bound form with albumin.
Calcium helps in enzyme activation, muscle contraction, coagulation of blood,
regulation of some hormonal secretions & cell membrane permeability.
Increased levels are found in hyperthyroidism, malignant tumors, acute &
osteoporosis, adrenal insufficiency.
Decreased levels are found in hypoparathyrodism, osteomalacia, rickets, renal
failure & tetanus.
PRINCIPLE
At a neutral pH the Ca2+ form with Arsenazo III a complex, the color intensity of
which is directly proportional to the concentration of calcium in the sample.
REAGENT COMPOSITION
CALCIUM ARSENAZO REAGENT 2 x 35 mL
MES, pH 6.50 1000 mmol/L
Arsenazo III 200 mmol/L
REAGENTS REQUIRED BUT NOT PROVIDED
Multi Calibrator ( Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 16 mg/dL.
If the concentration is greater than linearity (16 mg/dL), dilute the sample with
normal saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following values may be used as guide line.
Serum / plasma : 8.8 – 10.2 mg/dL
Urine : 100-400 mg/24 hrs
SAMPLE
Serum / plasma (free of haemolysis)
Urine diluted 1/3 with distilled water; adjust to pH 3-4 with HCI (N/10).
Take dilution factor into account for the calculation of the concentration in urine.
CALIBRATION
Agappe Multicalibrator( Product Code No - 11610001)is recommended for
calibration .
Quality Control – It is recommended to use Qualicheck Norm (Code No. 11601003)
or Qualicheck path (Code No. 11601002) to verify the performance of the
measurement procedure.
Each Laboratory has to establish its own internal quality control scheme and
procedures for corrective action if controls do not recover within the acceptable
tolerance.
BIBLIOGRAPHY
Baver, P.J. Anal. Biochem., 110, (1981), 61

ADL/V.01/APR 2012
CALCIUM (ARSENAZO)
Parameters Screen Calibration Screen
Test Cal Rule Two Point Linear
No Sensitivity
Full Name Calcium A Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type End Point Difference Limit
Primary WL 630 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time 0 15 Determination Coeff. 0
Incubation Time QC Screen
Unit mg/dL Control 1
Precision 0.1 Control 2
R1 300 µL
R2 0
Sample 3µL
R1 Blank 0 15000
Mixed Rgt.Blank
Linearity Range 0 15
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Reference Screen
Low
High

ADL/V.01/APR 2012
 2 x 30 mL
CHLORIDE 12005007
INTENDED USE
This reagent is intended for in vitro quantitative determination of Chloride in serum,
plasma & urine.
-Modified Thiocyanate method
-Linear up to 130 mEq/L
CLINICAL SIGNIFICANCE
Chloride & bicarbonate are the principle anions (-vely charged) where as sodium &
potassium are the principle cations (+vely charged) in the plasma. Chloride ions are
involved in regulation of water distribution between the tissues by maintaining
osmotic pressure & normal cation & anion balance between intra & extra cellular
fluids.
Elevated levels are seen in conditions like dehydration & congestive cardiac failure.
Decreased levels are seen in condition such as salt losing nephritis, diabetic acidosis
& renal failure.
PRINCIPLE
In an acid medium chloride ions and mercury ( II) thiocynate form thiocynate ions.
These ions react with HNO3 and iron (III) ions and effect a red color. The intensity
of the color is directly proportional to the concentration of chloride ions.
REAGENT COMPOSITION
CHLORIDE REAGENT 2 x 30 mL
Mercuric (II) thiocyanate 2 mmol/L
Nitric acid 29 mmol/L
Ferric Nitrate 20 mmol/L
REAGENTS REQUIRED BUT NOT PROVIDED
Multi Calibrator ( Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at room temperature.
LINEARITY
This reagent is linear up to 130 mEq/L
If the concentration is greater than linearity (130 mEq/L), dilute the sample with
distilled water and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following values may be used as guideline.
Serum : 97 - 108 mEq/L
Urine : 120 - 240 mEq/L/24 hr
SAMPLE
Serum / plasma (free of haemolysis) / Urine (Dilute sample 1:1 with distilled water
and multiply the result with 2)
CALIBRATION
Agappe Multicalibrator( Product Code No - 11610001)is recommended for
calibration .
Quality Control – It is recommended to use Qualicheck Norm (Code No. 11601003)
or Qualicheck path (Code No. 11601002) to verify the performance of the
measurement procedure.
Each Laboratory has to establish its own internal quality control scheme and
procedures for corrective action if controls do not recover within the acceptable
tolerance.
BIBLIOGRAPHY
Schonfed R.G.Lowellen C.S: Clin Chem.10,533 pp (1964)

ADL/V.01/APR 2012
CHLORIDE
Parameters Screen Calibration Screen
Test Chloride Rule Two Point Linear
No Sensitivity
Full Name Chloride Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type End Point Difference Limit
Primary WL 510 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time 0 15 Determination Coeff. 0
Incubation Time QC Screen
Unit mEq/L Control 1
Precision 0.1 Control 2
R1 250 µL
R2 0
Sample 3 µL
R1 Blank 0 1000
Mixed Rgt.Blank
Linearity Range 0 130
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Reference Screen
Low
High

ADL/V.01/APR 2012
 4 x 35 mL
CHOLESTEROL 12005008
INTENDED USE
This reagent is intended for in vitro quantitative determination of Cholesterol in
serum or plasma.
-CHOD-PAP methodology.
-Linear up to 600 mg/dL.
-Contains LCF (Lipamic Clearing factor) which minimizes rerun.
CLINICAL SIGNIFICANCE
Cholesterol is the main lipid found in the blood, bile & brain tissues. It is also one
of the most important steroids of the body & is a precursor of many steroid
hormones. Two thirds of cholesterol present in the blood is esterified. The liver
metabolizes the cholesterol & it is transported in the blood stream by lipoproteins.
Increased levels are found in hypercholesterolemia, hyperlipidemia, hypothyroidism,
uncontrolled diabetes, nephritic syndrome & cirrhosis.
Decreased levels are found in malabsorption, malnutrition, hyperthyroidism,
anaemia & liver diseases.
PRINCIPLE
Enzymatic determination of total cholesterol according to the following reactions.
CHE
Cholesterol ester +H2O ------------> Cholesterol + fatty acids
CHO
Cholestrol + O2 ----------------> 4-Cholesten-3- one + H2O2
POD
2H2O2 +Phenol+4-Aminoantipyrine-------------> Red quinone + 4H2O
CHE : Cholesterol Esterase
CHO : Cholesterol Oxidase
POD : Peroxidase
REAGENT COMPOSITION
CHOLESTEROL (S.L) R1 4 x 35 mL
Pipes buffer (pH 6.70) 50 mmol/L
Phenol 24 mmol/L
Sodium Cholate 0.5 mml/L
Cholesterol Esterase > 180 U/L
Cholesterol Oxidase > 200 U/L
Peroxidase > 1000 U/L
4 – aminoantipyrine 0.5 mmol/L
Reagents Required But not Provided
Multi Calibrator ( Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2- 80C.
LINEARITY
This reagent is linear up to 600 mg/dL.
If the concentration is greater than linearity ( 600 mg/dL), dilute the sample with
normal saline and repeat the assay. Multiply with dilution factor
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum, Plasma : 150 – 220 mg/dL
SAMPLE
Serum, Plasma (free of haemolysis).
CALIBRATION
Agappe Multicalibrator( Product Code No - 11610001)is recommended for
calibration .
Quality Control – It is recommended to use Qualicheck Norm (Code No. 11601003)
or Qualicheck path (Code No. 11601002) to verify the performance of the
measurement procedure.
Each Laboratory has to establish its own internal quality control scheme and
procedures for corrective action if controls do not recover within the acceptable
tolerance.
BIBLIOGRAPHY
Allain C.C. et al., Clin.Chem 20 (1974), 470

ADL/V.01/APR 2012
CHOLESTEROL
Parameters Screen Calibration Screen
Test CHO Rule Two Point Linear
No Sensitivity
Full Name Cholesterol Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type End Point Difference Limit
Primary WL 510 SD
Sec. WL 630 Blank Response
Direction Increase Error Limit
Reaction Time 0 24 Determination Coeff.
Incubation Time QC Screen
Unit mg/dL Control 1
Precision 0.1 Control 2
R1 300 µL
R2 0
Sample 3 µL
R1 Blank 0 2000
Mixed Rgt.Blank
Linearity Range 0 600
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC Abs
Reference Screen
Low 150
High 220

ADL/V.01/APR 2012
 4 x 35 / 2 x 18 mL
CREATININE 12002055

INTENDED USE: This reagent is intended for in vitro quantitative determination of

creatinine in serum, plasma & urine.
CLINICAL SIGNIFICANCE
It is formed in muscles from phospho creatinine. It is important form of energy being
a store of high-energy phosphate. Creatinine determinations have one advantage over
Urea determination that it is not affected by a high protein diet.
Serum creatinine is more specific & sensitive indicator of renal function. Simultaneous
estimations of serum urea & creatinine provides better information. Serum urea
nitrogen, creatinine ratio is > 15 in pre renal failure, & < 10 in renal failure.
Decreased levels are found in muscle dystrophy.
PRINCIPLE
Creatinine reacts with picric acid to produce a colored compound, creatinine alkaline
picrate. The change in absorbance is proportional to the creatinine concentration.
REAGENT COMPOSITION
CREATININE DYE REAGENT 4 x 35 mL
Picric Acid 8.73 mmol/L
Surfactant
CREATININE BASE REAGENT 2 x 18 mL
Sodium hydroxide 300 mmol/L
Sodium Phosphate 25 mmol/L

Reagents required but not provided

Multicalibrator ( Product Code No. 11610001)
Qualichek Norm ( Product Code No. 11601003)
Qualichek Path ( Product Code No. 11601002)
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at room temperature.
This reagent is linear up to (24 mg/dL).
If the concentration is greater than linearity (24 mg/dL), dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum : Men : 0.7 – 1.4 mg/dL
Female : 0.6 – 1.2 mg/dL
Urine : : 0.80 – 1.80 gm/24 hr
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of working reagent to light.
SAMPLE
Serum / plasma (free of haemolysis) / Urine (diluted 1/100 with distilled water)
CALIBRATION
Agappe Multicalibrator (Code No. 11610001) is recommended for calibration of this
assay.
Quality Control – It is recommended to use Qualicheck Norm (Code No. 11601003)
or Qualicheck path (Code No. 11601002) to verify the performance of the
measurement procedure.
Each Laboratory has to establish its own internal quality control scheme and
procedures for corrective action if controls do not recover within the acceptable
tolerance.
BIBLIOGRAPHY
1. Allen. L.C.: Clin chem.Vol.28 No.3, 1982, 555.
2. Haeckel, R. et al. Chlin. Chem. 27/1 179-183 (1981).
3. Tanganelli, E. Prencipe, L; Bassi, D. Cambiaghi, S. and Murador,E.: Clin.Chem 287,
1461-1464 (1982)
CREATININE
Parameters Screen Calibration Screen
Test CRT Rule Two Point Linear
No Sensitivity
Full Name Creatinine Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type Fixed Time Difference Limit
Primary WL 510 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time 4 12 Determination Coeff. 0
Incubation Time 5 QC Screen
Unit mg/dL Control 1
Precision 0.1 Control 2
R1 200 µL
R2 200 µL
Sample 40 µL
R1 Blank
Mixed Rgt.Blank
Linearity Range 0 24
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC Abs
Reference Screen
Low
High
 1 x 30 / 1 x 8 mL
CREATINE KINASE 12005010
INTENDED USE CALIBRATION
This reagent is intended for in vitro Quantitative determination of Creatine Kinase Agappe Multicalibrator(Product Code No - 11610001)is recommended for
in human serum. calibration .
-Optimized IFCC Method. Quality Control : It is recommended to use Qualicheck Norm (Code No. 11601003)
-Linear up to 1700 U/L. or Qualicheck path (Code No. 11601002) to verify the performance of the
CLINICAL SIGNIFICANCE measurement procedure.
It is mainly found in all muscle (Cardiac & Skeletal) & brain tissues. It plays an Each Laboratory has to establish its own internal quality control scheme and
important role in energy storing mechanism of the tissues. Its iso-enzymes: CK-MB procedures for corrective action if controls do not recover within the
mainly exists in cardic muscle tissues, CK-MM in skeletal muscle tissues & CK-BB in acceptable tolerance.
brain & lungs. BIBLIOGRAPHY
Increased levels are found in myocardical infarction, muscular dystrophy, 1. DGKC,J.Clin.chem.clin.Bioch.15,255(1977)
cerebrovascular-disease, pulmonary infarction, electrical shocks & hypothyrodisim. 2. Di.Witt, Trendelenberg, J.Clin.Chemie,clin. Bioch.20,235(1982)
Decreased levels are, sometimes seen in early pregnancy.
PRINCIPLE
Kinetic determination of Creatinine Kinase is based on following reactions
CK
Creatinine Phophate + ADP ------------> Creatine + ATP
HK
ATP + D-Glucose --------------------> G-6-p+ADP
G-6-PDH
G-6-P + NADP+ ---------------> D-Gluconate -6-Phosphate + NADPH + H+
CK- Creatinine Kinase
Hk- Hexokinase
G-6-P-D- Glucose-6-phosphate
G-6-PDH- Glucose-6 Phosphate dehydrogenase
REAGENT COMPOSITION
CREATINE KINASE R1 1 x 30 mL
Imidazole (pH 6.7) 125 mmol/L
D-Glucose 25 mmol/L
N-Acetyl-L-Cysteine 25 mmol/L
Magnesium acetate 12.5 mmol/L
NADP 2.52 mmol/L
EDTA 2.02 mmol/L
Hexokinase > 6800 U/L
CREATINE KINASE(S.L) R2 1 x 8 mL
Creatine Phosphate 250 mmol/L
ADP 15.2 mmol/L
AMP 25 mmol/L
Diadenosine-5-pentaphosphate 103 µmmol/L
G-6-PDH >88800 U/L
Reagents Required But not Provided
Multi Calibrator (Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 1700 U/L.
If the concentration is greater than linearity (1700 U/L), dilute the sample with
normal saline and repeat the assay. Multiply the final result with dilution factor.
NORMAL VALUES
It is recommended that each laboratory establish its own reference value.
The following values may be used as guide line.
Men : < 171 U/L
Women : < 145 U/L
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
SAMPLE
Serum/Plasma (Free of haemolysis)

ADL/V.01/APR 2012
CREATINE KINASE
Parameters Screen Calibration Screen
Test CK- NAC Rule Two Point Linear
No Sensitivity
Full Name CK- NAC Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type Kinetic Difference Limit
Primary WL 340 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time 8 20 Determination Coeff. 0
Incubation Time 5 QC Screen
Unit U/L Control 1
Precision 0.1 Control 2
R1 200 µL
R2 50 µL
Sample 12.5 µL
R1 Blank 0 10000
Mixed Rgt.Blank 0 10000
Linearity Range 0 2000
Linearity Limit 0.2
Substrate Limit 20000
Factor
Prozone chek
q1 q2 q3 q4
PC
Reference Screen
Low
High

ADL/V.01/APR 2012
 2 x 35 / 2 x 12 mL
ENZYMATIC CREATININE 12005012
INTENDED USE
This reagent is intended for in vitro quantitative determination creatinine in serum BIBLIOGRAPHY
or urine. Artiss. J.D. Mc Enroe, R.J.Zak B.Clin.Chem, 30 (1984)1389.
-High Linearity of 200 mg/dL
-No sample dilution
-Ready to use reagents
-MSDS available for analyzers
CLINICAL SIGNIFICANCE
It is formed in muscles from phosphocreatinine. It is important form of energy being
a store of high energy phosphate. Creatinine determinations have one advantage
over urea determination that it is not affected by a high protein diet.
Serum creatinine is more specific & sensitive indicator of renal function.
Simultaneous estimations of serum urea & creatinine provides better information.
Serum urea nitrogen & creatinine ratio is > 15 in prerenal failure & < 10 in renal
failure. Decreased levels are found in muscle dystrophy.
PRINCIPLE
Creatininase
Creatinine +H2O --------------------------> Creatine
Creatinase
Creatine + H2O ---------------------------> Sarcosine +Urea
Sarcosine Oxidase
Sarcosine + O2+H 2O ----------------------------> Glycine + HCHO + H 2O2
Peroxidase
2 H2O2 + 4-AA *1+ TOOS *2 ---------------------> Quinone pigment +4 H2O
*1 : 4- Aminoantipyrine, * 2N-Ethyl –N-(2-Hydroxy -3-Sulfopropyl)-m-toluidine
CRE concentration can be obtained by measuring quinone pigment photometrically
REAGENT COMPOSITION
CREATININE R1 2 x 35 mL
Creatinase 175000 IU/L
Sacrosine Oxidase 15000 lU/L
TOOS 1.13 mmol
CREATININE R2 2 x 12 mL
Creatininase 75000 IU/L
Peroxidase 4500 units /L
4-AA 0.75 mmol
Reagents Required But not Provided
Multi Calibrator ( Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C
LINEARITY
This reagent is linear up to 200 mg/dL
If the concentration is greater than linearity dilute the sample with normal saline
and repeat the assay. Multiply the result with dilution factor.
NORMAL VALUES
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum : Male : 0.6 – 1.1 mg/dL
: Female : 0.5 – 0.8 mg/dL
Urine : Male : 1070–2150 md/dL(24 hrs-accumulated urine)
: Female : 769 – 1200 mg/dL (24 hr accumulated urine)
PRECAUTION
To avoid contamination, use clean laboratory materials.
Avoid direct exposure of reagent to light.
SAMPLE
Fresh Serum/Urine 24 hr
CALIBRATION
Agappe Multicalibrator( Product Code No - 11610001)is recommended for
calibration .
Quality Control – It is recommended to use Qualicheck Norm (Code No. 11601003)
or Qualicheck path (Code No. 11601002) to verify the performance of the
measurement procedure.
Each Laboratory has to establish its own internal quality control scheme and
procedures for corrective action if controls do not recover within the acceptable
tolerance.

ADL/V.01/APR 2012
ENZYMATIC CREATININE
Parameters Screen Calibration Screen
Test Enzy CRT Rule Two Point Linear
No Sensitivity
Full Name Enzymatic Creatinine Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type End Point Difference Limit
Primary WL 546 SD
Sec. WL 630 Blank Response
Direction Increase Error Limit
Reaction Time -1 22 Determination Coeff. 0
Incubation Time 20 QC Screen
Unit mg/dL Control 1
Precision 0.1 Control 2
R1 225 µL
R2 75 µL
Sample 6 µL
R1 Blank 0 1500
Mixed Rgt.Blank 1 1700
Linearity Range 0 200
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Reference Screen
Low
High

ADL/V.01/APR 2012
 1 x 30 / 1 x 8 mL
GAMMA GT 12005013
INTENDED USE
This reagent is intended for in vitro Quantitative determination of GAMMA GT in
serum.
-Szasz methodology.
-Linear up to 232 U/L.
CLINICAL SIGNIFICANCE
GGT activity is elevated in all forms of liver diseases. It is highest in cases of
intrahepatic or post hepatic biliary obstruction. (It may be 5 to 30 times higher than
normal) It is more sensitive than Alkaline Phosphatase , NTP, Leucine
aminopeptidase and transaminases in detection of obstructive jaundice, cholangitis,
cholecystis neoplasm, it rises earlier than other enzyme and persists longer.
Moderate increase is observed in infectious hepatitis. (2 to 5 times) Increases may
also be observed in cases of drug intoxication, acute and chronic pancreatitis.
PRINCIPLE
Kinetic determination of Gamma GT according to the following reaction.
Gamma GT
GLUPA-C+Glycylglycine --------------> L-Gamma-Glutamyl-Glycylglycine
+ 5-Amino-2-nitrobenzoic acid.

GLUPA-C: L-Gamma -Glutamyl-3 Carboxy-P-nitroanilide

REAGENT COMPOSITION
Gamma GT R1 1 x 30 ml
Tris buffer pH (8.25) 133 mmol/L
Glycylglycine 138 mmol/L
Gamma GT R2 1 x 8 ml
GLUPA - C 23 mmol/L
Reagents Required But not Provided
Multi Calibrator ( Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 232 U/L.
If the concentration is greater than linearity (232 U/L) dilute the sample with normal
saline and repeat the assay. Multiply the result with dilution factor.
NORMAL VALUES
It is recommended that each laboratory establish its own reference value.
The following values may be used as guide line.
Female : 5-32 U/L
Male : 10-45 U/L
PRECAUTION
To avoid contamination, use clean laboratory wares. .
Avoid direct exposure of reagent to light.
SAMPLE
Fresh Serum (free of haemolysis)
CALIBRATION
Agappe Multicalibrator( Product Code No - 11610001)is recommended for
calibration .
Quality Control – It is recommended to use Qualicheck Norm (Code No. 11601003)
or Qualicheck path (Code No. 11601002) to verify the performance of the
measurement procedure.
Each Laboratory has to establish its own internal quality control scheme and
procedures for corrective action if controls do not recover within the acceptable
tolerance.
BIBLIOGRAPHY
1. Szasz, G.Clin.Chem., 22, (1976),2051
2. SCJ.Clin. Lab.Invest 36: 711 (1976)
3. Tietz N.W. Text book of Clin.Chem. 678 686 : (1986)

ADL/V.01/APR 2012
GAMMA GT
Parameters Screen Calibration Screen
Test GGT Rule Two Point Linear
No Sensitivity
Full Name GGT Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type kinetic Difference Limit
Primary WL 405 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time 4 12 Determination Coeff. 0
Incubation Time 10 QC Screen
Unit U/L Control 1
Precision 0.1 Control 2
R1 200 µL
R2 50 µL
Sample 25 µL
R1 Blank 0 10000
Mixed Rgt.Blank 0 13000
Linearity Range 0 200
Linearity Limit 0.2
Substrate Limit 18000
Factor
Prozone chek
q1 q2 q3 q4
PC Abs
Reference Screen
Low
High

ADL/V.01/APR 2012
 4 x 35 mL
GLUCOSE 12602001
INTENDED USE
This reagent is intended for in vitro quantitative determination of Glucose in serum,
plasma & CSF
-GOD –PAP methodology
-Linear up to 600 mg/dL
CLINICAL SIGNIFICANCE
Glucose is a major carbohydrate present in the blood & serves as a primary source
of energy. It is usually obtained from ingested starch & sugar. The glucose
concentration is normally maintained at constant level. Excessive glucose is stored
as a inactive glycogen mainly in the liver & little in the muscles.
Elevated blood glucose levels are found in diabetes mellitus, hyperthyroidism,
hyperadrenalism & certain liver diseases.
Decreased levels are found in Insulinoma, hypothyroidism, hypopituitarism.
PRINCIPLE
Enzymatic colorimetric determination of glucose according to the following reaction.
GOD
Glucose+ O2 + 2H2O --------------------> H2O2 + Gluconic acid
POD
2H2O2+phenol + 4-Ap -------------------> Quinonimine + 4H 2O
GOD – Glucose Oxidase
POD – Peroxidase
REAGENT COMPOSITION
GLUCOSE REAGENT R1 4 x 35 mL
Tris Buffer, (pH 7.40) 92 mmol/L
Phenol 0.3 mmol/L
Glucose Oxidase 15000 U/L
4- Aminophenazone 2.6 mmol/L
Reagents Required But not Provided
Multi Calibrator ( Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 600 mg/dL
If the concentration is greater than linearity (600 mg/dL), dilute the sample with
normal saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following values may be used as guide line.
Serum : Fasting : 70-110 mg/dL
2 hrs postprandial : 70-140 mg/dL
CSF : 50 -70 mg/dL
PRECAUTION
To avoid contamination, use clean laboratory materials.
Avoid direct exposure of reagent to light.
SAMPLE
Serum / plasma (free of haemolysis) / CSF
CALIBRATION
Agappe Multicalibrator( Product Code No - 11610001)is recommended for
calibration .
Quality Control – It is recommended to use Qualicheck Norm (Code No. 11601003)
or Qualicheck path (Code No. 11601002) to verify the performance of the
measurement procedure.
Each Laboratory has to establish its own internal quality control scheme and
procedures for corrective action if controls do not recover within the acceptable
tolerance.
BIBLIOGRAPHY
1. Trinder, P. Ann Clin Biochem. 6,24 (1979)
2. Dingeon, B. Ann.Bio.Clin 33,3 (1975)
3. Lott, J. Clin.Chem. 21, 1754 (1975)

ADL/V.01/APR 2012
GLUCOSE
Parameters Screen Calibration Screen
Test Glucose Rule Two Point Linear
No Sensitivity
Full Name Glucose Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type EP Difference Limit
Primary WL 510 SD
Sec. WL 630 Blank Response
Direction Increase Error Limit
Reaction Time 0 38 Determination Coeff.
Incubation Time QC Screen
Unit mg/dL Control 1
Precision 0.1 Control 2
R1 300 µL
R2 0
Sample 3 µL
R1 Blank 0 2000
Mixed Rgt.Blank
Linearity Range 0 500
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC Abs
Reference Screen
Low 70
High 110

ADL/V.01/APR 2012
 2 x 30 / 2 x 10 mL
HDL – C DIRECT 12005015
INTENDED USE: This reagent is intended for in vitro quantitative determination of CALIBRATION
HDL Cholesterol in serum Agappe Multicalibrator( Product Code No - 11610001)is recommended for
CLINICAL SIGNIFICANCE calibration .
Blood total cholesterol levels have long been known to be related to coronary heart Quality Control – It is recommended to use Qualicheck Norm (Code No. 11601003)
disease (CHD). In recent years, in addition to total cholesterol, high density or Qualicheck path (Code No. 11601002) to verify the performance of the
lipoprotein cholesterol (HDL-C) has become an important tool used to assess an measurement procedure.
individual risk of developing CHD since a strong negative relationship between HDL- Each Laboratory has to establish its own internal quality control scheme and
C concentration and the incidence of CHD was reported. procedures for corrective action if controls do not recover within the acceptable
PRINCIPLE tolerance.
The reaction between cholesterol other than HDL & enzyme for cholesterol assay BIBLIOGRAPHY
is suppressed by the electrostatic interaction between polyanions & cationic 1. Williams P et al., High density lipoprotein and coronary risk factor, Lancet.
substances. Hydrogen peroxide is formed by the free cholesterol in HDL by 1:72 (1979)
cholesterol oxidase. Oxidative condensation of EMSE and 4-AA is caused by 2. Gordon,T.Castelli, W.P.Hjortland, M.C. et al. Am.J.Med 62, 707-714 (1977)
hydrogen peroxide in the presence of peroxidise, and the absorbance of the 3. Rifai, N.and Warnick, G.R., Ed. Laboratory Measurement of Lipids,
resulting red-purple quinine is measured to obtain the cholesterol value in HDL Lipoproteins and Apolipoproteins AACC Press. Washington, DC,USA,1994
Polyanions
Other lipoproteins than HDL------------> Suppress reaction with enzyme
Cationic substances
cholesterol esterase
HDL (cholesterol esters) + H2O ----------------> HDL (free cholesterol) + Free fatty acids
cholesterol oxidase
HDL (free cholesterol) + O2 + H+-------------------> Cholestenone + H2O2
Peroxidase
2H2O2 + 4-AA + EMSE + H 3 + O ---------------> Red-purple quinine + 5H2O
REAGENT COMPOSITION
HDL - C DIRECT R1 2 x 30 mL
N-Ethyl-N-(3-methylphenyl)-N’succinylethyenediame(EMSE)
HDL - C DIRECT R2 2 x 10 mL
Cholesterol Oxidase
4-Aminoantipyrine (4-AA)
Reagents Required But not Provided
Multi Calibrator (Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C, protected from light. Do not freeze.
LINEARITY
This reagent is linear up to 150 mg/dL
If the concentration is greater than linearity (150 mg/dL), dilute the sample with
normal saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Male : 35-80 mg/dL
Female : 42- 88 mg/dL
PRECAUTION
To avoid contamination, use clean laboratory materials. Use clean, dry disposable
pipette tips for dispensing. Close reagent bottles immediately after use.
Avoid direct exposure of reagent to light. Do not blow into the reagent bottles.
SAMPLE
Fresh serum (free of haemolysis)
INTERFERING SUBSTANCES
Test will not be affected by:
Bilirubin up to 40 mg/dL
Ascorbic acid up to 50 mg/dL
Hemoglobin up to 500 mg/dL
Triglyceride up to 1000 mg/dL
(when triglyceride in a sample exceeds 1000 mg/dL, dilute the sample to 1+9 with
saline, repeat the assay and multiply result by 10)

ADL/V.01/APR 2012
HDL – C DIRECT
Parameters Screen Calibration Screen
Test HDL D Rule Two Point Linear
No Sensitivity
Full Name HDL Direct Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type End Point Difference Limit
Primary WL 578 SD
Sec. WL 670 Blank Response
Direction Increase Error Limit
Reaction Time -1 22 Determination Coeff. 0
Incubation Time 20 QC Screen
Unit mg/dL Control 1
Precision 0.1 Control 2
R1 225 µL
R2 75 µL
Sample 3 µL
R1 Blank 0 1000
Mixed Rgt.Blank 0 3000
Linearity Range 0 200
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC Abs
Reference Screen
Low
High

ADL/V.01/APR 2012
 1 x 30 / 1 x 8 mL
LDH 12005016
INTENDED USE
This reagent is intended for in vitro quantitative determination of Lactate
Dehydrogenase in serum or plasma.Based on SCE recommended method.
-Linear up to 2400 U/L.
CLINICAL SIGNIFICANCE
This enzyme is found in all organ cells, but especially plentiful in cardiac & skeletal
muscle, liver, kidney & RBC. LDH is found in the form of iso-enzymes. Based on their
electrophoretic mobility with each iso-enzymes being primarily from different
organs.
Elevated levels are found in myocardial infraction, liver diseases, hemolytic
anaemia’s, pernicious anaemia, Leukemia & Pulmonary diseases. Elevations in acute
MI reaches a peack in 48-72 hrs. Delayed elevations, (10-14 days) are useful in the
late diagnosis of the condition.
PRINCIPLE
Kinetic determination of lactate dehydrogenase according to the following reaction.
LDH
Pyruvate + NADH + H+ -------------> L-Lactate +NAD+
REAGENT COMPOSITION
LDH -P R1 1 x 30 mL
Tris buffer (pH 7.4) 80 mmol/L
Pyruvate 1.6 mmol/L
Sodium Chloride 200 mmol/L
LDH – P R2 1 x 8 mL
NADH 240 mmol/L
Reagents Required But not Provided
Multi Calibrator ( Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 2400 U/L.
If the concentration is greater than linearity (2400 U/L), dilute the sample with
normal saline and repeat the assay. Multiply the result with dilution factor
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum /Plasma : 225-450 U/L
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
SAMPLE
Serum, plasma (free of haemolysis)
CALIBRATION
Agappe Multicalibrator( Product Code No - 11610001)is recommended for
calibration .
Quality Control - It is recommended to use Qualicheck Norm (Code No. 11601003)
or Qualicheck path (Code No. 11601002) to verify the performance of the
measurement procedure.
Each Laboratory has to establish its own internal quality control scheme and
procedures for corrective action if controls do not recover within the acceptable
tolerance.
BIBLIOGRAPHY
1. Z.Klin chem. Klin Biochem.8,658 (1970), 1, 1820(1972)
2. Wei Bhaar, D.et al. Med.Welt 26,387 (1975)

ADL/V.01/APR 2012
LDH
Parameters Screen Calibration Screen
Test LDH Rule Two Point Linear
No Sensitivity
Full Name LDH Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type kinetic Difference Limit
Primary WL 340 SD
Sec. WL Blank Response
Direction Decrease Error Limit
Reaction Time 4 12 Determination Coeff. 0
Incubation Time 10 QC Screen
Unit U/L Control 1
Precision 0.1 Control 2
R1 200 µL
R2 50 µL
Sample 3 µL
R1 Blank 0 20000
Mixed Rgt.Blank 1000 25000
Linearity Range 0 2000
Linearity Limit 0.2
Substrate Limit 8000
Factor
Prozone chek
q1 q2 q3 q4
PC Abs
Reference Screen
Low
High

ADL/V.01/APR 2012
 1 x 30 / 1 x 10 mL
LDL – C DIRECT 12005017
INTENDED USE CALIBRATION
This reagent is intended for in vitro quantitative determination of LDL Cholesterol Agappe Multicalibrator( Product Code No - 11610001)is recommended for
in serum or plasma calibration .
CLINICAL SIGNIFICANCE Quality Control – It is recommended to use Qualicheck Norm (Code No. 11601003)
Blood total cholesterol levels have long been known to be related to coronary heart or Qualicheck path (Code No. 11601002) to verify the performance of the
disease (CHD). In recent years, in addition to total cholesterol, low density measurement procedure.
lipoprotein cholesterol (LDL-C) has become an important tool used to assess an Each Laboratory has to establish its own internal quality control scheme and
individual risk of developing CHD since a strong positive relationship between LDL- procedures for corrective action if controls do not recover within the acceptable
C concentration and the incidence of CHD was reported. LDL Cholestrol acts as a tolerance.
key factor in the pathogenesis of atherosclerosis and coronary artery disease. BIBLIOGRAPHY
PRINCIPLE 1. Crouse J.R et al., Studies of low density lipoprotein molecular weight in human
The LDL-C Direct is a homogeneous assay. When serum is mixed with R1, amphoteric beingd with coronary artery disease. J.Lipid Res 26:5666 (1985)
surfactants protect LDL from enzyme reactions. CHE and CO reacts with non-LDL 2. Gordon,T.Castelli, W.P.Hjortland, M.C. et al. AM.J.Med 62, 707-714 (1977)
cholesterol, which decomposed to water by catalase. R2 enables the conversation Rifai, N.and Warnick, G.R., Ed. Laboratory Measurement of Lipids, Lipoproteins
of LDL-C to hydrogen peroxide, which upon oxidative condensation with HDAOS & and Apolipoproteins AACC Press. Washington, DC,USA,1994
4AA yields a color complex. By measuring the absorbance of this blue color complex
produced, the LDL-C concentration in the sample can be calculated when compared
with the absorbance of the LDL-C Calibrator.
REAGENT COMPOSITION
LDL –C DIRECT R1 1 x 30 mL
4-Aminoantipyrin 0.5 mmol/l
CHE
CO 1.2 U/mL
Peroxidase
Good’s buffer pH 6.3
LDL –C DIRECT R2 1 x 10 mL
N,N-bis(4-sulfobutyl)-m-toluidine
disodium salt (DSBmT) 1.0 mmol/l
Good’s buffer pH 6.3
Reagents Required But not Provided
Multi Calibrator ( Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 450 mg/dL
If the concentration is greater than linearity (450 mg/dL), dilute the sample with
normal saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Desirable < 130 mg/dL
Borderline 130-159 mg/dL
High Risk for CHD > 160 mg/dL.
PRECAUTION
To avoid contamination, use clean laboratory materials. Use clean, dry disposable
pipette tips for dispensing. Close reagent bottles immediately after use.
Avoid direct exposure of reagent to light. Do not blow into the reagent bottles.
SAMPLE
Fresh serum (free of haemolysis) or EDTA Plasma
INTEREFERING SUBSTANCES
Test will not be affected by:
Bilirubin up to 40 mg/dL
Ascorbic acid up to 50 mg/dL
Haemoglobin up to 500 mg/dL
Triglyceride up to 1000 mg/dL
(when triglyceride in a sample exceeds 1000 mg/dL, dilute the sample 1+9 with
saline, repeat the assay and multiply result by 10)

ADL/V.01/APR 2012
LDL – C DIRECT
Parameters Screen Calibration Screen
Test LDL D Rule Two Point Linear
No Sensitivity
Full Name LDL Direct Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type End Point Difference Limit
Primary WL 546 SD
Sec. WL 630 Blank Response
Direction Increase Error Limit
Reaction Time -1 22 Determination Coeff. 0
Incubation Time 20 QC Screen
Unit mg/dL Control 1
Precision 0.1 Control 2
R1 225 µL
R2 75 µL
Sample 3 µL
R1 Blank 0 15000
Mixed Rgt.Blank 0 3000
Linearity Range 0 450
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC Abs
Reference Screen
Low
High

ADL/V.01/APR 2012
 1 x 30 mL
MAGNESIUM 12005018
INTENDED USE
This reagent is intended for in vitro quantitative determination of Magnesium in
serum or plasma.
-Xylidyl Blue with ATCS
-Linear up to 5 mg/dL
CLINICAL SIGNIFICANCE
Magnesium is the second most abundant intracellular cation of the human body
after potassium, being essential in a great number of enzymatic and metabolic
processes.
It is a co-factor of all the enzymatic reactions that involve ATP and found in the
membranes that maintain the electrical excitability of muscular and nervous cells.
A low magnesium level is found in malabsorption syndrome, diuretics
aminoglucoside therapy, and hyperparathyroidism or diabetic acidosis.
Elevated concentration of magnesium is found in uremia, chronic renal failure,
glomerulo nephritis, Addison’s disease or intensive anti acid therapy.
Clinical diagnosis should not be made on a single test result; it should integrate
clinical and other laboratory data.
PRINCIPLE
Magnesium reacts with xylidyl Blue to form a colored compound in alkaline solution.
The intensity of the colour formed is proportional to the magnesium in the sample.
REAGENT COMPOSITION
MAGNESIUM REAGENT 1 x 30 mL
Xylidyl Blue 110 mmol/L
Ethanolamine (pH 11.0) 1 mol/L
GEDTA 60 mmol/L
Reagents Required But not Provided
Multi Calibrator ( Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 -80C, protected from light.
LINEARITY
This reagent is linear up to 5 mg/dL.
If the concentration is greater than linearity (5 mg/dL), dilute the sample with
normal saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following values may be used as guide line.
Serum : 1.8 – 2.6 mg/dL
CSF : 2.1 – 3.3 mg/dL
Urine : 73 - 122 mg/24 h
PRECAUTION
To avoid contamination, use clean laboratory materials. It is recommended to use
disposable tubes. Use clean, dry disposable pipette tips for dispensing. Close reagent
immediately after Use. Avoid direct exposure of reagent to light.
SAMPLE
Serum (free haemolysis) or Heparinized plasma.
(Do not use oxalates or EDTA as anticoagulant)
Urine should be acidified to pH 3-4 with concentrated HCl then dilute sample 1/5
with distilled water and multiply the result by 5.
CALIBRATION
Agappe Multicalibrator( Product Code No - 11610001)is recommended for
calibration .
Quality Control – It is recommended to use Qualicheck Norm (Code No. 11601003)
or Qualicheck path (Code No. 11601002) to verify the performance of the
measurement procedure.
Each Laboratory has to establish its own internal quality control scheme and
procedures for corrective action if controls do not recover within the acceptable
tolerance.
BIBLIOGRAPHY
1. Farrel, E.C. Magnesium. Kaplan a et al. Clin chem.. The CV Mosby Co St Louis
Torento. Princeton 1984; 1064-69
2. Brutis, C. A. et al. TIETZ textbook of clinical chemistry, 3 rd edition W B
Saunders company; 1999, P.1395-1457
3. Young, D. S. Effects of disease on clinical lab tests 4th edition AACC Press, 2001

ADL/V.01/APR 2012
MAGNESIUM
Parameters Screen Calibration Screen
Test Mag Rule Two Point Linear
No Sensitivity
Full Name Magnesium Replicates 1
Standard No. 2 Interval ( day)
Reaction Type End Point Difference Limit
Primary WL 546 SD
Sec. WL 0 Blank Response
Direction Increase Error Limit
Reaction Time 0 20 Determination Coeff. 0
Incubation Time QC Screen
Unit mg/dL Control 1
Precision 0.1 Control 2
R1 300 µL
R2
Sample 3 µL
R1 Blank
Mixed Rgt.Blank
Linearity Range 0 5
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC Abs
Reference Screen
Low
High

ADL/V.01/APR 2012
 1 x 30 mL
PHOSPHOROUS 12005019
INTENDED USE
This reagent is intended for in vitro quantitative determination of Phosphorous in
serum or plasma.
-Phosphomolybdate methodology
-Linear up to 15 mg/dL
CLINICAL SIGNIFICANCE
Phosphorous is mainly combined with calcium & is found in bones. It is involved in
the carbohydrate metabolism & is a component of many other substances. Some
of its important functions include maintaining of acid-base balance, skeletal muscle
formation. It is also required for normal functioning of RBCs & muscles.
Increased levels are found in hypothyroidism, renal failure, bone metastasis & liver
disease.
Decreased levels are found in hyperparathyroidism, osteomalacia & disease
associated with Vitamin D deficiency.
PRINCIPLE
Determination of inorganic phosphorous according to the following reaction.
phosphorous
Ammonium molybdate + sulfuricaid ----------------> phosphomolybidic
complex
REAGENT COMPOSITION
INORGANIC PHOSPHOROUS REAGENT 1 x 30 mL
Sulfuric acid 210 mmol/L
Ammonium molybdate 650 mmol/L
Reagents Required But not Provided
Multi Calibrator ( Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 80C.
LINEARITY
This reagent is linear up to 15 mg/dL.
If the concentration is greater than linearity (15 mg/dL), dilute the sample with
normal saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following values may be used as guide line.
Serum : 2.7 – 4.5 mg/dL
Urine : 400 – 1300 mg/24 hr.
PREPARATION AND STABILITY OF WORKING REAGENT
Reagent is ready to use.
PRECAUTION
To avoid contamination, use clean laboratory materials.
Avoid direct exposure of working reagent to light.
SAMPLE
Serum / Plasma (free of haemolysis)
Urine diluted to 1/10 with distilled water
CALIBRATION
Agappe Multicalibrator( Product Code No - 11610001)is recommended for
calibration .
Quality Control – It is recommended to use Qualicheck Norm (Code No. 11601003)
or Qualicheck path (Code No. 11601002) to verify the performance of the
measurement procedure.
Each Laboratory has to establish its own internal quality control scheme and
procedures for corrective action if controls do not recover within the acceptable
tolerance.
BIBLIOGRAPHY
1. Tietz, N., Clinical Guide to Laboratory Tests, W.B. Saunders Company, Philad,
1983, 384
2. Henry, R.J.Clin. Chem., Harper & Row Publishers. New Yoork 1974
3. Thomas, L., Labor and Diagnose, 2 Aufl. Med.Vert. Gem. Marburg 1979 Taussky,
H.H.Schorr, E.,J.Biol. Chem 202, 675 (1953)

ADL/V.01/APR 2012
PHOSPHOROUS
Parameters Screen Calibration Screen
Test Phos Rule Two Point Linear
No Sensitivity
Full Name Phosphorous Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type End Point Difference Limit
Primary WL 340 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time 0 15 Determination Coeff. 0
Incubation Time QC Screen
Unit mg/dL Control 1
Precision 0.1 Control 2
R1 250 µL
R2 0
Sample 5 µL
R1 Blank 0 3500
Mixed Rgt.Blank
Linearity Range 0 15
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Reference Screen
Low
High

ADL/V.01/APR 2012
 4 x 35 / 2 x 18 mL
SGOT 12005020
INTENDED USE
This reagent is intended for in vitro quantitative determination of SGOT in serum
or plasma.
-Proven IFCC methodology
-Linear up to 1000 U/L.
CLINICAL SIGNIFICANCE
It is present in most of the tissues, especially in cardiac muscle, liver cells, skeletal
muscle & kidneys. Injury to these tissues results in the release of the enzyme in
blood stream.
Increased levels are found in myocardial infarction. The duration & extent of
increase is related to the infract. SGOT determination is of considerable value to
differentiate myocardial infraction from other cardiac disorders.
Increased levels are also found in various types of liver disease, skeletal muscle
trauma & in renal diseases.
Decreased levels may be found in pregnancy, Beri-Beri & Diabetic ketoacidosis.
PRINCIPLE
Kinetic determination of Aspartate Aminotrasferase (AST) based upon the following
reaction.
AST
L- Asparate + a - ketoglutarate ------------------->Oxaloacete + L-Glutamate
MDH
Oxaloacetate + NADH + H+ -------------------> L- Malate + NAD+
AST :Aspartate aminotransferase.
MDH : Malate dehydrogenase.
REAGENT COMPOSITION
SGOT R1 4 x 35 mL
Tris Buffer (pH7.8) 88 mmol/L
L-Aspartate 260 mmol/L
MDH > 900 U/L
LDH > 1500 U/L
SGOT R2 2 x 18 mL
a -ketoglutarate 12 mmol/L
NADH 0.24 mmol/L
Reagents Required But not Provided
Multi Calibrator ( Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 1000 U/L.
If the concentration is greater than linearity (1000 U/L), dilute the sample with
normal saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum up to 46 U/L
PRECAUTION
To avoid contamination, use clean laboratory materials.
Avoid direct exposure of working reagent to light.
SAMPLE
Serum/plasma (free of haemolysis)
CALIBRATION
Agappe Multicalibrator( Product Code No - 11610001)is recommended for
calibration .
Quality Control – It is recommended to use Qualicheck Norm (Code No. 11601003)
or Qualicheck path (Code No. 11601002) to verify the performance of the
measurement procedure.
Each Laboratory has to establish its own internal quality control scheme and
procedures for corrective action if controls do not recover within the acceptable
tolerance.
BIBLIOGRAPHY
1. Clin, Chim, Acta 105,147-172 (1980).
2. Thefeld,W. et.al.,Dtsh.med.wschr.99,343 (1994)

ADL/V.01/APR 2012
SGOT
Parameters Screen Calibration Screen
Test SGOT Rule Two Point Linear
No Sensitivity
Full Name SGOT Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type Kinetic Difference Limit
Primary WL 340 SD
Sec. WL Blank Response
Direction Decrease Error Limit
Reaction Time 4 12 Determination Coeff. 0
Incubation Time 10 QC Screen
Unit U/L Control 1
Precision 0.1 Control 2
R1 200 µL
R2 50 µL
Sample 10 µL
R1 Blank 0 20000
Mixed Rgt.Blank 10000 25000
Linearity Range 0 350
Linearity Limit 0.2
Substrate Limit 8000
Factor
Prozone chek
q1 q2 q3 q4
PC Abs
Reference Screen
Low
High

ADL/V.01/APR 2012
 4 x 35 / 2 x 18 mL
SGPT 12005021
INTENDED USE
This reagent is intended for in vitro quantitative determination of SGPT in serum
or plasma.
-IFCC recommended methodology
-Linear up to 1000 U/L.
CLINICAL SIGNIFICANCE
It is present in most of the tissues, but mainly found in the liver. Increased levels
are found in hepatitis, cirrhosis, obstructive jaundice & other hepatic disease. SGPT
activity is markedly elevated even before clinical signs of jaundice become apparent
in disease associated with hepatic necrosis. Slight elevations are also found in
myocardial infraction.
PRINCIPLE
Kinetic determination of SGPT base on the following reaction.
ALT
L-Alanine + a-ketogutarate -------------------> Pyruvate +L-Glutamate
LDH
Pyruvate +NADH+ H+ ----------------------------> L-Lactate +NAD+
ALT – Alanine aminotranferase
LDH - Lactate dehydrogenase
REAGENT COMPOSITION
SGPT R1 4 x 35 mL
Tris buffer (pH 7.5) 110 mmol/L
L-Alanine 600 mmol/L
LDH > 1500 U/L
SGPT R2 2 x 18 mL
NADH 0.24 mmol/L
a-ketoglutarate 16 mmol/L
Reagents Required But not Provided
Multi Calibrator ( Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 1000 U/L.
If the concentration is greater than linearity (1000 U/L), dilute the sample with
normal saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum up to 49 U/L
PRECAUTION
To avoid contamination use clean laboratory materials.
Avoid direct exposure of reagent to light.
SAMPLE
Serum/plasma (free of haemolysis)
CALIBRATION
Agappe Multicalibrator( Product Code No - 11610001)is recommended for
calibration .
Quality Control – It is recommended to use Qualicheck Norm (Code No. 11601003)
or Qualicheck path (Code No. 11601002) to verify the performance of the
measurement procedure.
Each Laboratory has to establish its own internal quality control scheme and
procedures for corrective action if controls do not recover within the acceptable
tolerance.
BIBLIOGRAPHY
1. Clin, Chim, Acta 105,147-172 (1980).
2. Thefeld, W. et.al.,Dtsh.med.wschr.99,343 (1994)

ADL/V.01/APR 2012
SGPT
Parameters Screen Calibration Screen
Test SGPT Rule Two Point Linear
No Sensitivity
Full Name SGPT Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type Kinetic Difference Limit
Primary WL 340 SD
Sec. WL Blank Response
Direction Decrease Error Limit
Reaction Time 4 12 Determination Coeff. 0
Incubation Time 10 QC Screen
Unit U/L Control 1
Precision 0.1 Control 2
R1 200 µL
R2 50 µL
Sample 10 µ L
R1 Blank 0 20000
Mixed Rgt.Blank 10000 25000
Linearity Range 0 350
Linearity Limit 0.2
Substrate Limit 8000
Factor
Prozone chek
q1 q2 q3 q4
PC Abs
Reference Screen
Low 0
High 49

ADL/V.01/APR 2012
 4 x 30 mL
TOTAL PROTEIN 12005022
INTENDED USE
This reagent is intended for in vitro quantitative determination of Total Protein in
serum or plasma.
-Direct Biuret Method
-Linearity up to 15 gm/dL.
CLINICAL SIGNIFICANCE
Proteins form the major portion of dissolved substances in the plasma. They form
the basic structural components of the body. They constitute the enzymes present
in our body & also act as secondary source of energy. The other functions include
distribution of water, buffering, transport of various components, defense &
coagulation of blood in our body.
Increased levels are found in dehydration & myeloma.
Decreased levels are found in liver disorders, Nephrotic syndrome, malnutrition &
protein due to haemorrhage.
PRINCIPLE
Colorimetric determination of total protein based on the principle of the Biuret
reaction (copper salt in an alkaline medium). Protein in plasma or serum sample
forms a blue colored complex when treated with cupric ions in alkaline solution.
The intensity of the blue color is proportional to the protein concentration.
REAGENT COMPOSITION
TOTAL PROTEIN REAGENT 4 x 30 mL
Potassium Iodide 6 mmol/L
Potassium sodium tartarate 21 mmol/L
Copper Sulphate 6 mmol/L
Sodium hydroxide 58 mmol/L
Reagents Required But not Provided
Multi Calibrator ( Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at room temperature .
LINEARITY
The procedure is linear up to 15 gm/dL.
If the concentration is greater than linearity (15 gm/dL), dilute the sample with
normal saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum : 6.2 – 8.0 gm/dL
PRECAUTION
To avoid contamination, use clean laboratory materials.
Avoid direct exposure of reagent to light.
SAMPLE
Serum / plasma (free of haemolysis)
CALIBRATION
Agappe Multicalibrator( Product Code No - 11610001)is recommended for
calibration .
Quality Control – It is recommended to use Qualicheck Norm (Code No. 11601003)
or Qualicheck path (Code No. 11601002) to verify the performance of the
measurement procedure.
Each Laboratory has to establish its own internal quality control scheme and
procedures for corrective action if controls do not recover within the acceptable
tolerance.
BIBLIOGRAPHY
Gomall, A.J.Biol. Chem, 177 C (1949) 751

ADL/V.01/APR 2012
TOTAL PROTEIN
Parameters Screen Calibration Screen
Test TPR Rule Two Point Linear
No Sensitivity
Full Name Total Protein Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type End Point Difference Limit
Primary WL 546 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time 0 22 Determination Coeff. 0
Incubation Time QC Screen
Unit g/dL Control 1
Precision 0.1 Control 2
R1 250 µL
R2 0
Sample 5 µL
R1 Blank 0 3000
Mixed Rgt.Blank
Linearity Range 0 15
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Reference Screen
Low
High

ADL/V.01/APR 2012
 4 x 35 mL
TRIGLYCERIDES 12005023
INTENDED USE CALIBRATION
This reagent is intended for in vitro quantitative determination of Triglycerides in Agappe Multicalibrator( Product Code No - 11610001)is recommended for
serum or plasma. calibration .
-GPO-PAP methodology Quality Control – It is recommended to use Qualicheck Norm (Code No. 11601003)
-Linear up to 1000 mg/dL. or Qualicheck path (Code No. 11601002) to verify the performance of the
-Contains LCF (Lipaemic clearing factor ) which minimizes returns measurement procedure.
CLINICAL SIGNIFICANCE Each Laboratory has to establish its own internal quality control scheme and
procedures for corrective action if controls do not recover within the acceptable
Triglycerides are simple lipids, formed in the liver by glycerol & fatty acids. They tolerance.
are transported by VLDL, LDL & constitute about 95% of fat, stored as source of
energy in the tissue & plasma. BIBLIOGRAPHY
Increased levels are found in hyperlipidemias, diabetes, nephrotic syndrome & 1. Schettler G. Nussel,E,Arav, Med. 10,25 (1975) J
hypothyroidism. Increased levels are risk factor for arteriosclerotic coronary disease, 2. Jacobs,N.J. ,Van Demark,P.J. Arch Biochem. Biophy. 88,250-255 (1960)
peripheral vascular disease, acute pancreatitis & hyperlipoproteinaemia. Decreased
levels are found in malnutrition & hyperthyroidism.
PRINCIPLE
Enzymatic determination of triglyceride is based on following reactions:
Lipoprotein lipase
TGL+H2O -------------------------> Glycerol + Fatty acid
Glycerol kinase
Glycerol + ATP ---------------------------> Glycerol-3-phosphate + ADP
GPO
Glycerol-3-phospahte+O2 --------------> Dihydroxyacetone phosphate
+H2O2
POD
H2O2+4-Aminoantipyrine+p-Chlorophenol---------------> Quinone+4H2O
GPO = Glycereol-3-phosphate Oxidase.
LPL = Lipoprotein Lipase
GK = Glycerol Kinase
AAP=aminoantipyrin
REAGENT COMPOSITION
TRIGLYCERIDES 4 x 35 mL
Pipes –buffer (pH 7.00) 50 mmol/L
p-Chlorophenol 5.3 mmol/L
Potassium ferrocynate 10 mmL
Magnesium salt 17 mmol/L
4-Aminoanyipyrine 0.9 mmol/L
ATP 3.15 mmol/L
Lipoprotein lipase >1800 U/L
Glycerol Kinase > 450 U/L
Glycerol -3-phosphate oxidase > 3500 U/L
Peroxidase >450 U/L
Reagents Required But not Provided
Multi Calibrator ( Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
LINEARITY
This reagent is linear up to 1000 mg/dL.
If the concentration is greater than linearity (1000 mg/dL), dilute the sample with
normal saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following values may be used as guide line.
Male 60-165 mg/dL
Female 40-140 mg/dL
PRECAUTION
To avoid contamination, use clean laboratory materials.
Avoid direct exposure of reagent to light.
SAMPLE
Serum / plasma (free of haemolysis)

ADL/V.01/APR 2012
TRIGLYCERIDES
Parameters Screen Calibration Screen
Test TGL Rule Two Point Linear
No Sensitivity
Full Name Triglycerides Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type End Point Difference Limit
Primary WL 510 SD
Sec. WL 630 Blank Response
Direction Increase Error Limit
Reaction Time 0 20 Determination Coeff.
Incubation Time QC Screen
Unit mg/dL Control 1
Precision 0.1 Control 2
R1 300 µL
R2 0
Sample 3 µL
R1 Blank 0 3000
Mixed Rgt.Blank
Linearity Range 0 1000
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC Abs
Reference Screen
Low
High

ADL/V.01/APR 2012
 4 x 30 / 2 x 16 mL
UREA U V 12005024
INTENDED USE
This reagent is intended for in vitro quantitative determination of urea in serum,
plasma & urine.
-Urease / GLDH methodology
-Linear up to 300 mg/dL
CLINICAL SIGNIFICANCE
Proteins cannot be stored in human body, so excess should be broken down. Amino
acids which from the components of proteins, break down to give ammonia. This
is toxic & so through a series of chemical reactions (urea cycle) non toxic urea is
produced & this is released into the blood which is filtered in the kidney & excreted
in the urine.
Elevated levels are seen during increased protein breakdown, dehydration, vomiting,
diarrhea. Also seen in any kind of renal disorder like Glomerular nephritis, Chronic
nephritis & Nephritic syndrome.
Decreased levels are found in liver failure & pregnancy..
PRINCIPLE
urease
Urea + H2O --------------------> 2NH3 + CO2
GLDH
2 NH4+2a-ketoglutarate + 2NADH --------------> 2L-Glutamate+2NAD+ 2H2O
REAGENT COMPOSITION
UREA U.V. R1 4 x 30 mL
Buffer (pH 7.6) 100 mmol/L
ADP 0.7 mmol/L
a-ketoglutarate 9.0 mmol/L
GLDH >1100 U/L
Urease >6500 U/L
UREA U.V. R2 2 x 16 mL
NADH 0.25 mmol/L
2-Oxoglutarate 5 mmol/L
Reagents Required But not Provided
Multi Calibrator ( Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 300 mg/dL.
If the concentration is greater than linearity (300 mg/dL), dilute the sample with
normal saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Serum/Plasma : 10-50 mg/dL
Urine : 20-35 gm/24 hr
PRECAUTION
To avoid contamination, use clean laboratory wares.
Avoid direct exposure of reagent to light.
SAMPLE
Serum, plasma (free of haemolysis).
(Do not use anticoagulants containing fluorides and ammonium ions)
Urine (Diluted to 1/100 with Dilled water)
Multiply the result with the dilution factor.
CALIBRATION
Agappe Multicalibrator( Product Code No - 11610001)is recommended for
calibration .
Quality Control – It is recommended to use Qualicheck Norm (Code No. 11601003)
or Qualicheck path (Code No. 11601002) to verify the performance of the
measurement procedure.
Each Laboratory has to establish its own internal quality control scheme and
procedures for corrective action if controls do not recover within the acceptable
tolerance.
BIBLIOGRAPHY
1. Talke, H. and Schubert G.E.Kiln-Wocchsr 43: 174 (1965)
2. Kassirer, J.P.,New Eng. J.Med. 285,385 (1971)

ADL/V.01/APR 2012
UREA U V
Parameters Screen Calibration Screen
Test UREA Rule Two Point Linear
No Sensitivity
Full Name Urea UV Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type Fixed time Difference Limit
Primary WL 340 SD
Sec. WL Blank Response
Direction Decrease Error Limit
Reaction Time 3 7 Determination Coeff. 0
Incubation Time 6 QC Screen
Unit mg/dL Control 1
Precision 0.1 Control 2
R1 200 µL
R2 50 µL
Sample 3 µL
R1 Blank 0 10000
Mixed Rgt.Blank 10000 25000
Linearity Range 0 300
Linearity Limit
Substrate Limit 8000
Factor
Prozone chek
q1 q2 q3 q4
PC Abs
Reference Screen
Low
High

ADL/V.01/APR 2012
 2 x 35 mL
URIC ACID 12602001
INTENDED USE: This reagent is intended for in vitro quantitative determination of
Uric acid in serum, plasma & urine.
-Uricase methodology.
-Linear up to 25 mg/dL.
CLINICAL SIGNIFICANCE
Uric acid is the end product of purine metabolism. Uric acid is excreted by the
kidneys.
Increased levels are found in Gout, arthritis, impaired renal functions & starvation.
Decreased levels are found in yellow atrophy of the liver.
PRINCIPLE
Enzymatic determination of Uric acid according to the following reactions.
Uricase
Uric acid + 2H2O+O2 ----------------------> Allantoine +CO2 +H2O2
Peroxidase
2H2O2 + 4 – Aminoantipyrine +EHSPT--------------->Red quinone
EHSPT= N-Ethyl N-(2-Hydroy -3 Sulfopropyl) n-Toluidine
REAGENT COMPOSITION
URIC ACID R1 2 x 35 mL
Phosphate Buffer (pH 7.5) 100 mmol/L
EHSPT 1.10 mmol/L
Ferrocyanure 50 mmol/L
Amino -4-antipyrine 0.37 mmol/L
Peroxidase > 3000 U/L
Uricase > 140 U/L
Reagents Required But not Provided
Multi Calibrator ( Product Code No - 11610001)
Qualicheck path (Product Code No - 11601002)
Qualicheck norm (Product Code No - 11601003)
STORAGE & STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2 - 80C.
LINEARITY
This reagent is linear up to 25 mg/dL.
If the concentration is greater than linearity (25 mg/dL), dilute the sample with
normal saline and repeat the assay. Multiply the result with dilution factor.
NORMAL RANGE
It is recommended that each laboratory establish its own reference values.
The following values may be used as guide line.
Serum / Plasma :
Men 3.4-7.0 mg/dL
Women 2.4-5.7 mg/dL
PRECAUTION
To avoid contamination, use clean laboratory materials.
Avoid direct exposure of reagent to light.
SAMPLE
Serum, EDTA or Heparin plasma (free of haemolysis)
CALIBRATION
Agappe Multicalibrator( Product Code No - 11610001)is recommended for
calibration .
Quality Control – It is recommended to use Qualicheck Norm (Code No. 11601003)
or Qualicheck path (Code No. 11601002) to verify the performance of the
measurement procedure.
Each Laboratory has to establish its own internal quality control scheme and
procedures for corrective action if controls do not recover within the acceptable
tolerance.
BIBLIOGRAPHY
1. Barham,D.,Trider P., Analyst 97,142 (1972)
2. Fossatj Clin. Chem. 26/2,227 (1980)

ADL/V.01/APR 2012
URIC ACID
Parameters Screen Calibration Screen
Test Uric Acid Rule Two Point Linear
No Sensitivity
Full Name Uric Acid Replicates 1
Standard No. 2 Interval ( day) 0
Reaction Type End Point Difference Limit
Primary WL 546 SD
Sec. WL 670 Blank Response
Direction Increase Error Limit
Reaction Time 0 38 Determination Coeff. 0
Incubation Time QC Screen
Unit mg/dL Control 1
Precision 0.1 Control 2
R1 300 µL
R2
Sample 6 µL
R1 Blank 0 2000
Mixed Rgt.Blank
Linearity Range 0 15
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC Abs
Reference Screen
Low
High

ADL/V.01/APR 2012
 1 x 15 /1 x 5/ 1x 32 /4 x0.5mL 2 x15/2 x5 /1x 63/4x0.5mL
HbA1c DIRECT WITH CALIBRATOR 11835001 11835002

INTENDED USE GENERAL SYSTEM PARAMETER FullyAuto

This reagent is intended for in vitro quantitative determination of HbA1c in human Mode of Reaction End point
blood. Slope of reaction Increasing
Latex enhanced Immunoturbidimetry
Wavelength 660 nm
Ready to use liquid stable reagents
Temperature 370C
Multipoint calibration
Direct result (% HbA1c) from analyzer Calibrator Concentration As on vial label
No total Hb determination required Linearity 13%
Blank Reagent blank
CLINICAL SIGNIFICANCE
Sample volume 7.5 μL
HbA1c is a glycated form of haemoglobin formed by the attachment of glucose
residues in the blood to the hemoglobin molecules. In the diabetic population Reagent 1 volume 180 μL
where blood glucose levels are abnormally elevated the level of HbA1c also Reagent 2 volume 60 μL
increases. The level of HbA1c is proportional to the level of glucose in the blood Cuvette 1 cm light path
and has been widely accepted as an indicator of the mean blood glucose
concentration in the preceeding 6-8 weeks. It is therefore a long-term indicator of LABORATORY PROCEDURE FOR FULLY AUTO
diabetic control. For routine use HbA1c levels should be monitored every 3-4 Blank Calibrator Sample/control
months. However in gestational diabetes and after a change in therapy it may be HbA1c R 1 180 μL 180 μL 180 μL
useful to measure HbA1c more frequently at 2-4 week intervals.
Calibrator - 7.5μL -
PRINCIPLE Hemolysate(sample/control) - - 7.5μL
The principle of the test is latex agglutination method that measures the ratio of
hemoglobin A1c that occupy in a total hemoglobin in the whole blood. The sample Mix & incubate for 5 min at 370C.
(hemolysis sample ) is added to the unsensitized latex particles, and the surfaces of HbA1c R 2 60 μL 60 μL 60 μL
the latex adsorbs a total hemoglobin in the sample. Anti human HbA1c mouse Mix and incubate for 5 min at 37oC and read absorbance(A) at 660 nm.
monoclonal antibody complex agglutinates by anti-mouse IgG goat antibody. At this
time, the amount of agglutination caused depends on the amount of HbA1c that CALCULATION
adsorbs the surface of the latex, this this agglutination is measured as a turbidity. the Calibration curve
concentration of HbA1c (%) in the sample is determined by referring to the calibration
curve obtained by the same test of diluted standard solutions. Calculate the Abs of calibrators = Abs calibrator – Abs Blank. Plot the D Abs of each
calibrator versus assigned concentration (HbA1c %) on a linear graph paper. HbA1c
REAGENT COMPOSITION results according to NGSP for the samples and controls are determined using the
HbA1c R1 1 x 15 mL/2 x 15 mL prepared calibration curve.
Latex Calculate
HbA1c R2 1 x 5 mL / 2x 5 mL Abs of sample ie abs Sample - abs Blank .
Anti-human HbA1c mouse monoclonal antibody HbA1c % in the sample is calculated by interpolation of Abs of sample on the
Anti-mouse IgG goat antibody calibration curve. For calculation of results according to IFCC, use IFCC calibrator
values (see calibrator insert), or use following equation.
HbA1c R3 1 x 32 mL / 1 x 63 mL NGSP = (0.915 x IFCC) + 2.15
Haemolysis Reagent
HbA1c DIRECT CALIBRATOR 4 x 0.5 mL
HbA1c 4 level calibrator (lyophilized). INTERFERENCES
No interference upto :
STORAGE AND STABILITY Ascorbic acid 50 mg/dL
The sealed reagents are stable up to the expiry date stated on the label, when stored Bilirubin 40mg/dL
at 2- 80C, protected from light. Once opened the reagent is stable upto four weeks, if
contamination is avoided. Recalibration is recommended after 30 days. DO NOT FREEZE Intra lipid 3000 mg/dL
Calibrator : Reconstitute the calibrator with 0.5mL distilled water. It is stable for 30
days at 2-8oC . DO NOT FREEZE. It has been reported that results may be inconsistent in patients who have the
following conditions: opiate addiction, lead poisoning, alcoholism, and ingestion of
LINEARITY RANGE large doses of aspirin. Elevated HbF levels may lead to under estimation of HbA1c.
The reagent is linear upto 13% (NGSP)
BIBLIOGRAPHY
REFERENCE RANGE 1. Engbeak, F., et al. Clin chem.35 p. 93-97 (1989)
It is recommended that each laboratory establish its own reference values. 2. American Diabetes Association : Clinical practice recommendations (position
The following value may be used as guide line. statement). Diabetes care 24 (suppl.1) S33-S55, (2001).
Reference normal value (NGSP): 4.6% -6.2% 3. Tietz, N.W. Textbook of Clinical Chemistry, W.B. Saunders Company, p.794 -795
(1999).
PRECAUTION
To avoid contamination, use clean laboratory wares. Use clean, dry disposable pipette
tips for dispensing. Close reagent and standard bottles immediately after use.
Avoid direct exposure of working reagent to light.
SAMPLE
Whole blood, collected with EDTA
To determine HbA1c a heamolysate must be prepared for each sample
1. Dispense 1mL hemolysis reagent into a tube.
2. Add 20 μLof well-mixed whole blood and mix.
3. Allow to stand for 5 minutes or until complete lysis is evident.

Follow the same procedure with controls and calibrator.

ADL/V.02/July 2013
 1 x 30/1 x 10/2 x 63 mL
HbA1c DIRECT 12005057
INTENDED USE: This reagent is intended for in vitro quantitative determination of
HbA1c in human blood. SAMPLE
-Latex enhanced Immunoturbidimetry Whole blood, collected with EDTA
-Multipoint calibration To determine HbA1c a heamolysate must be prepared for each sample
-Direct result in % HbA1c from analyzer 1. Dispense 1mL hemolysis reagent into a tube.
2. Add 20 μL of well-mixed whole blood and mix.
-No total Hb determination required 3. Allow to stand for 5 minutes or until complete lysis is evident.
CLINICAL SIGNIFICANCE Follow the same procedure with controls and calibrator.
HbA1c is a glycated form of haemoglobin formed by the attachment of glucose
residues in the blood to the hemoglobin molecules. In the diabetic population INTERFERENCES
where blood glucose levels are abnormally elevated the level of HbA1c also No interference up to :
increases. The level of HbA1c is proportional to the level of glucose in the blood
and has been widely accepted as an indicator of the mean blood glucose Ascorbic acid 50 mg/dL
concentration in the preceeding 6-8 weeks. It is therefore a long-term indicator of Bilirubin 40 mg/dL
diabetic control. For routine use HbA1c levels should be monitored every 3-4 Intralipid 3000 mg/dL
months. However in gestational diabetes and after a change in therapy it may be It has been reported that results may be inconsistent in patients who have the
useful to measure HbA1c more frequently at 2-4 week intervals. following conditions: opiate addiction, lead poisoning, alcoholism, and ingestion of
PRINCIPLE large doses of aspirin. Elevated HbF levels may lead to under estimation of HbA1c.
The principle of the test is latex agglutination method that measures the ratio of BIBLIOGRAPHY
hemoglobin A1c that occupy in a total hemoglobin in the whole blood. The sample 1. Engbeak, F., et al. Clin chem.35 p. 93-97 (1989)
(hemolysis sample ) is added to the unsensitized latex particles, and the surfaces of 2. American Diabetes Association : Clinical practice recommendations (position
the latex adsorbs a total hemoglobin in the sample. Anti human HbA1c mouse statement). Diabetes care 24 (suppl.1) S33-S55, (2001).
monoclonal antibody complex agglutinates by anti-mouse IgG goat antibody. At this 3. Tietz, N.W. Textbook of Clinical Chemistry, W.B. Saunders Company, p.794 -795
time, the amount of agglutination caused depends on the amount of HbA1c that (1999).
adsorbs the surface of the latex, this this agglutination is measured as a turbidity. the
concentration of HbA1c (%) in the sample is determined by referring to the calibration
curve obtained by the same test of diluted standard solutions.
REAGENT COMPOSITION
HbA1c R1 1 x 30 mL
Latex
HbA1c R2 1 x 10 mL
Anti human HbA1c mouse monoclonal antibody
Anti-mouse IgG goat antibody
HbA1c R3 2 x 63 mL
Haemolysis Reagent
Reagent required but not provided
Agappe HbA1C Direct Multicalibrator ( 11604001)
STORAGE AND STABILITY
The sealed reagents are stable up to the expiry date stated on the label, when stored
at 2- 8 0C, protected from light. Stability in the instrument is four weeks, if
contamination is avoided. Recalibration is recommended after 30 days. DO NOT FREEZE
LINEARITY
The reagent is linear up to 13% (NGSP)
REFERENCE RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Reference normal value (NGSP): 4.6% -6.2%
PREPARATION AND STABILITY OF WORKING REAGENT
Reagent 1 & Reagent 2 are ready to use.
CALIBRATION
Agappe HbA1C Direct Multicalibrator ( 11604001) is recommended for calibration
of this assay. Reconstitute the calibrator with 0.5 mL distilled water and it will be stable
up to 30 days at 2-80C. Do not freeze.
Quality Control
It is recommended to use Agappe HbA1C Control Level 1&2 (11625002) to verify
the performance of the assay. Each laboratory has to establish its own internal quality
control scheme and procedure for corrective action, if controls do not recover with
in the acceptable tolerance.
PRECAUTION
To avoid contamination, use clean laboratory wares. Use clean, dry disposable pipette
tips for dispensing. Close reagent and standard bottles immediately after use.
Avoid direct exposure of working reagent to light.

xxxxxxxxxxxxxxxxxxxxxx ADL/V.02/28.06.2013
+91 484 3120 002
HbA1c DIRECT
Parameters Screen Calibration Screen
Test HbA1c D Rule Spline
No Sensitivity
Full Name HbA1c Direct Replicates 1
Standard No. 5 Interval ( day) 0
Reaction Type Endpoint Difference Limit
Primary WL 670 SD
Sec. WL Blank Response
Direction Increase Error Limit
Reaction Time -1 19 Determination Coeff. 0
Incubation Time 12 QC Screen
Unit % Control 1 *
Precision 0.01 Control 2 *
R1 180 μL
R2 60 μL
Sample 7.5μL
R1 Blank
Mixed Rgt.Blank
Linearity Range 3 13
Linearity Limit
Substrate Limit
Factor
Prozone chek
q1 q2 q3 q4
PC
Refence Screen
Low *
High *
* Data entered by the operator

xxxxxxxxxxxxxxxxxxxxxx ADL/V.01/28.06.2013
+91 484 3120 002
 1 x 26 mL/1 x 9 mL/1x 63 mL
HbA1c DIRECT 12013042
INTENDED USE: This reagent is intended for in vitro quantitative determination of
HbA1c in human blood. INTERFERENCES
Latex enhanced Immunoturbidimetry No interference upto :
Multipoint calibration Ascorbic acid 50 mg/dL
Direct result in % HbA1c from analyzer Bilirubin 40 mg/dL
No total Hb determination required Intralipid 3000 mg/dL
CLINICAL SIGNIFICANCE
HbA1c is a glycated form of haemoglobin formed by the attachment of glucose It has been reported that results may be inconsistent in patients who have the
residues in the blood to the hemoglobin molecules. In the diabetic population following conditions: opiate addiction, lead poisoning, alcoholism, and ingestion of
where blood glucose levels are abnormally elevated the level of HbA1c also large doses of aspirin. Elevated HbF levels may lead to under estimation of HbA1c.
increases. The level of HbA1c is proportional to the level of glucose in the blood BIBLIOGRAPHY
and has been widely accepted as an indicator of the mean blood glucose 1. Nathan, D.M., Clin, Chem. 29, pp.466-469 (1983)
concentration in the preceeding 6-8 weeks. It is therefore a long-term indicator of 2. Engbeak, F., et al. Clin chem.35 pp. 93-97 (1989)
diabetic control. For routine use HbA1c levels should be monitored every 3-4 3. American Diabetes Association : Clinical practice recommendations (position
months. However in gestational diabetes and after a change in therapy it may be statement). Diabetes care 24 (suppl.1) S33-S55, (2001).
useful to measure HbA1c more frequently at 2-4 week intervals. 4. Tietz, N.W. Textbook of Clinical Chemistry, W.B. Saunders Company,
PRINCIPLE p.794 -795 (1999).
The kit is based on latex agglutination method that measures the ratio of hemoglobin
A1c that occupy in a total haemoglobin in the whole blood. The sample is added to
the unsensitization latex particles, and the surfaces of the latex adsorbs a total
haemoglobin in the sample. Anti -human HbA1c mouse monoclonal antibody is to
react and anti-human Hba1c mouse monoclonal antibody complex agglutinates by
anti-mouse IgG goat anti body. At this time the amount of agglutination caused
depends on the amount of HbA1c that adsorbs the surface of the latex, this
agglutination is measured as a turbidity. The concentration of HbA1c(%)in the whole Mispa Mini Assay Parameter
blood is calculated from a standard curve.
REAGENT COMPOSITION Page 1
HbA1c R1 1 x 26 mL Test (Name) HbA1c
Latex Decimal 2
HbA1c R2 1 x 9 mL Unit %
Anti-human HbA1c mouse monoclonal antibody Reac. Method End
Anti mouse IgG goat antibody Blank R Blank
HbA1c R3 1 x 63 mL
Wave length I 670
Haemolysis Reagent
Reagent required but not provided Wave length II -
Agappe HbA1C Direct Multicalibrator ( 11604001) Test Time 270 - 300
STORAGE AND STABILITY Sample 8 μL
The sealed reagents are stable up to the expiry date stated on the label, when stored R1 210 μL
at 2- 8 0C, protected from light. Stability in the instrument is four weeks, if R2 70 μL
contamination is avoided. Recalibration is recommended after 30 days. DO NOT FREEZE
PRECAUTION Calculation Method Spline
Close reagent and standard bottles immediately after use. Keep the reagent back to
specified temperature after each use
Avoid direct exposure of reagent to light.
Avoid freezing of reagents and refrigerate them at proper temperature. Shake R1
and R2 reagent well before use.
LINEARITY
The reagent is linear up to 13% (NGSP)
REFERENCE RANGE
It is recommended that each laboratory establish its own reference values.
The following value may be used as guide line.
Reference normal value (NGSP) : 4.6 - 6.2 %
PREPARATION AND STABILITY OF REAGENT
Reagent 1, reagent R2 and reagent R3 are ready to use.
CALIBRATION
Agappe HbA1C Direct Multicalibrator (11604001) is recommended for calibration of
this assay. Reconstitute the calibrator with 0.5 mL distilled water and it will be stable
up to 30 days at 2-80C. Do not freeze.
Quality Control
It is recommended to use Agappe HbA1C Control level 1&2 (11625002) to verify the
performance of the assay. Each laboratory has to establish its own internal quality
control scheme and procedure for corrective action, if controls do not recover with
in the acceptable tolerance.
SAMPLE
Whole blood, collected with EDTA
To determine HbA1c a heamolysate must be prepared for each sample
1. Dispense 1mL hemolysis reagent into a tube.
2. Add 20 μL of well-mixed whole blood and mix.
3. Allow to stand for 5 minutes or until complete lysis is evident.
Follow the same procedure with controls and calibrator.

SYMBOLS USED ON THE LABELS : IVD IN VITRO DIAGNOSTIC USE SEE PACKAGE INSERT FOR PROCEDURE LOT LOT NUMBER MANUFACTURER’S ADDRESS MANUFACTURING DATE EXPIRY DATE TEMPERATURE LIMIT
AGAPPE DIAGNOSTICS LTD. ISO 9001 : 2008
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