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BII,INUBIN (T}In[M)
Il0 ltetn0f, @ ffiilffiry

CLINICAL SIGNIFICANCE :
Bilirubin, I product of red blood cell destruction, is a bile

Reagent Blank Sample/Calibrator
pigment normally found in the blood. The average life
expectancy of red blood cells is 120 days. Approximately Sample/Calibrator 40 pl
Reagent 1 q00 pl
6 g!'n of hemoglobin is released per day due to their 400 pl
disintegration. Reticuloendothelial cells from the spleen, liver, Mix incubate for 5 min read Absorbance Al and then add
and bone marrow phagocytize aged red cells and convert the Reagent 2 100 pl 100 pl
released hemoglobin to bilirubin. Serum albumin links to Mix incubate for exactly 5 min and read A2
bilirubin and transports it to the liver where it is metabolized.
AA = t(A2-A1) Sample / Calibrator - [nz-Al)RBI
Elevated serum bilirubin can indicate impairment of tiver J
excretory function, excessive hemolysis, or biliary tract CALCUIATION:

obstruction. Hyperbilirubinemia can also be associated with Wth Calibrator
obstructive jaundice, hemolytic and hepatic jaundice, M sample
infectious hepatitis, and pernicious anemia. Bilirubin Diect [mg/dlJ =- AA Calibrator x C [mg/dlJ
C = Concentration of Calibrator
TEST PRINCIPLE :
P hotometric test with sta bi

REFERENCE RANGE :
I iz ed 2,4- D ich lorophenyld iazon i u m
salt ('DC") : Adult: upto 0.2 mg/dL
Direct Bilirubin forms a red diazo dye with DC-derivative in The above reference range is guideline and all the laboratories must establish
acidic solution. their own normal reference range. Final diagnosis should be made with
conelation of clinical factors.
REAGENTS COMPOSITION:
Rl: SulphaminicAdd 70 mmol/L, Nacl 6.6 g/L, stabilisors
PRECAUTIONS
R2: 2,4-Dichlorophenyldiazoniumsalt 0.09 rnmol/L, HCI 130 mmol/L ,
Detergent, Stabilisors 1. Do not pipette by mouth therefore avoid contact of the reagent with skin.
Do not swallow avoid contact to skin. ln case of skin contact wash off with
All the components of the kit are stable until the expiration
with plenty of water.
date on the label when stored tightly closed at z-Boc,
and contaminations prevented during their use. Do not use 2. Use clean glassware and miuotips while pipetting
reagents over the expiration date. Once opened the reagent
is stable for 1 months at 2 - 8oC. 3. Avoid contamination of the reagent during the assay process.
KIT CONTENTS : 4. Before the assay begins, bring all the reagents to room temperature.
Pack size : (60m1) CODE No. BILDO1
Reagent 1: 1 x 48 ml
Reagent?: 1 x 12ml 5. Do not freeze or expose the reagents to high temperature and
protect from direct sunlight as it will affect the performance of the kit.
Pack size : (480m1) CODE No. B|LDO2
Reagent 1 : 4 x96 ml
Reagent2 : 2 x48 ml 6. Programmes for specific autoanalysers are available on request.
Pack size : (LW120ml) CODE No. BILDLWO1 8. For accuracy of results, the assay procedure, reagent preparation
Reagent 1: 6 x16 ml Reagent2 : 2 x 12 ml and storage has to be meticulously followed.
.
SAMPLES : 9. As with all the diagnostic procedures, the physician should evaluate data
obtained by the use of this kit in light of other clinical information.
Serum or heparinised plasma
(Bilirubin is very light sensitive, therefore carefully protect
Performance Datia 1SZoCl :
from light)
Precision
\Mthin - run reproducibility Between - run reproducibility
CALIBRATORS & CONTROLS: N=20 N=20
Mean SD SD
For the calibration of
automated analyzers Greiner mg/dl mg/dl
CV
o/o
Mean
mg/dl mg/dl %
CV
Multicalibrator Unical is recommended, for quality control Sample 1 0.36 0.01 312 Sample 1 0.35 0.01 3.34
use Greiner GmbH normal and abnormal control, Unitrol I Sarnple 2 076 0.01 1.46 Sample 2 0.75 0.01 1.00
Sample 3 2.07 0.03 1.30 Sample 3 2.13 0.02 0.71
and Unitrol ll.
INTERFERENCES
UNEARW AND DETECTION LIMIT :
The following analyze were tested up to the levets indicated The linearity limit of the standard serum procedure is up to an direct Bilirubin
and found not to interfere with activity of 10 mg/dl and detection limit 0.1mg/dl.
- Ascorbic Acid: up to 30 mg/dL At higher concentration activities the sample has to be diluted 1 + 4 with
- Hemoglobin: no interferences up to 50 mg/dl normal saline, the result multiplied by 5.
- Triglycerides: no interference up to 1000 mgldl
PROCEDURE: Before the assay begins, bring all the

BIBLIOGRAPHY
reagents to room temperature.
1.Thomas L ed. Clinical Laboratory Diagnostics. 1st ed. Frankfurt TH-Bodks Vertagsgesetlschaft,
Direct Bilirubin 1998.p. '192-202.
Wave length : 546 nm (540-560) 2. Tolman KG, Rej R. Liver furption. ln: Burtis CA,Ashwood ER, editors. Tietz Textbook of Clinical
Temperature : 37oG Chemistry. 3rd ed. Philadelphia: W.B Saunders Company; 1999. p.1125-77.
Cuvette : 1 cm light path 3. Rard RN, di Pasqua A. A new diazo method for thedetermination of bilirubin. Clin Chem
Read against Reagent Blank (RB) 1962;6:570€.
rI Manufacturedby: DhTEK lleelthcell h/t LU.

P.54, Phaoel, Kalyanilndu$rid Estate, Kdyani, Did.: Nadia, Pin :741235 E-mdl :didok@redftneil.corn
KIT INSERT (lnstruction for use)
Corporde Offioe : P-27, Kalindi Ho.rsing Scfidno, Kdlndi, Kolkata- 700089, Hdp line : 033 - 2522n75 BILDDC lKll01 1 10412023 Rev:01

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BII,INUBIN (T}In[M)

Il0 ltetn0f, @ ffiilffiry

Bilirubin, I product of red blood cell destruction, is a bile

excretory function, excessive hemolysis, or biliary tract CALCUIATION:

P hotometric test with sta bi

PROCEDURE: Before the assay begins, bring all the

rI Manufacturedby: DhTEK lleelthcell h/t LU.

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