RF TURBILATEX

INTENDED USE:
The reagent kit is intended for the” invitro” quantitative determination of
Rheumatoid factor in human serum.
PROCEDURE:
Calibration Curve : (Range from 20 to 160 IU/ml) Prepare the
CLINICAL SIGNIFICANCE: following RF calibrator dilutions in normal saline. Multiply the
Rheumatoid factors are a group of antibodies directed to determinants in concentration of the RF-calibrator by the corresponding factor stated in
the Fc portion of the immunoglobulin G molecule. Although rheumatoid table bellow to obtain the RF concentration of each dilution.
factors are found in a number of rheumatoid disorders, such as systemic
lupus erythematosus (SLE) and Siogren's syndrome as well as in non- Calibrator dilution 1 2 3 4 5 6
rheumatic conditions, its central role in clinic lies in its utility as an aid in the Calibrator RF (µl) - 10 25 50 75 100
diagnosis of Rheumatoid Arthritis (RA) Normal Saline 100 90 75 50 25 -
.A study of the "American College of Rheumatology" show that the 80.4%
Factor 0 0.1 0.25 0.5 0.75 1.0
of RA patient were RF positive.

PRINCIPLE: One point calibration : (Linear range up to 100 IU/ml)

The RF - Turbilatex is a quantitative turbidimetric test for the measurement Prepare RF calibrator dilution : 30 µl RFcalibrator + 70 µl normal
of RF in human serum or Plasma.Latex particles coated with human
saline. Multiply the RF calibrator concentration by 0.30 to
gamma globulin are agglutinated w hen mixed with samples containing
RF. The agglutination causes an absorbance change, dependent upon obtain the RF concentration of the diluted calibrator.
the RF contents of sample that can be quantified by comparison from CALCULATION OF RESULTS:
calibrator of a known RF concentration. Calibration curve (Note 1) : Calculate the absorbance difference
(A2-Ablankreagent) of each point of the calibration curve and plot the value
CONTENTS: obtained against the RF concentration of each calibrator dilution.
Reagent 1 : Diluent Rheumatoid factorconcentration in the sample is calculated by interpolation
Reagent 2 : Latex Antigen of its (A2-A blank reagent )in the calibration curve.
Reagent 3 : RF Calibrator
One Point Calibration
(A2-A blank reagent Sample )
MATERIALS REQUIRED BUT NOT PROVIDED: RF IU/mL. = X Diluted Calibrator concentration
- Clean & Dry Glassware.
- Laboratory Glass Pipettes or Micropipettes & Tips. (A2-A blank reagent calibrator )
- Bio-Chemistry Analyzer.
PROCEDURE :
SAMPLES: Reagent Blank Calibrator Sample
Fresh serum stable for 7 days at 2 -8°C or 3 months at -20° C. Samples
with presence of fibrin should be centrifuged before testing. Do not use Working Reagent 1.0 ml 1.0 ml 1.0 ml
highly hemolyzed or lipemic samples. Normal Saline 7 µl - -
Calibrator * - 7 µl -
PREPARATION OF WORKING REAGENT Sample - - 7 µl
Working Reagent : Swirl the latex vial gently before use Prepare
Mix and read the absorbance after 2 min of the sample addition.
the necessary amount as follow : For multipoint calibrator use all the 6 calibrators stated as here above.
1 ml latex reagent + 9 ml Diluent. For single point calibration use diluted calibrator as shown here above
RF Calibrator : Reconstitute with 2.0 ml of Distilled water. Mix
gently and keep at room temperature for 10 minutes before use. NORMAL VALUE:
Up to 20 IU/ml
Each laboratory should establish its own reference range.
STORAGE & STABILITY:.
Working Reagent : Stable for 30 days at 2 -8° C LINEARITY:
The reaction is linear up to 160 IU/ml.
RF Calibrator : Stable for 1 month at 2-8°C or 3 months at -20°C.
Do not freeze; frozen latex or diluent could change the functionality of the PAERFORMANCE CHARACTERISTS:
test. 1. Linearity Limit : Up to 160 IU/ml by multi-standard & 100 IU/ml by one
point calibration.
2. Detection Limit : Values less than 6 IU/ml give non-reproducible results.
GENERAL SYSTEM PARAMETERS: 3. Prozone Effect : No prozone effect was detected up to 800 IU/ml.
Reaction Type : End point / Multi Standard
Wavelength : 650 nm (600-650 nm) QUALITY CONTROL:
0 It is recommended that each laboratory should prepare their own quality
Cuvette Temperature : 37 C
control scheme.
Calibrator Concentration : Dilution Factor x Calibrator Concentration
Incubation : 2 min. LIMITATIONS AND PRECAUTIONS:
Sample Volume : 7 µl - Storage conditions mentioned on the kit to be adhered.
- Bilirubin (20mg/dl) Haemoglobin (10 g/L), Lipemia (10 g/L)do not terfere.
Reagent Volume : 1 ml Other substances may interfere.
Zero Setting : Deionised Water
Blank : Reagent blank REFERENCES:
1. Frederick Wolfe et al. Arthritis and Rheumatism 1991; 34: 951-960.
Light Path : 1 cm.
2. Robert W Dorner et al. Clinica Chimica Acta 1987; 167: 1-21.
Calibrator concentration : 153 IU/ml 3. Robert H Shmerling et al. The American Journal of Medicine 1991; 91: 528-
534.
IVD
CODE NO. PACK SIZE
UNIONPROJET S.R.L.S.

T03 50 ML EC REP Via Aliprandi 41-20851

Lissone (MB)
www.jas-anz.com.au/register

ISO 9001:2015 ISO 13485:2003