RF Turbi

RF
LATEX TURBIDIMETRY
Quantitative determination of Rheumatoid Factors (RF) IVD
SUMMARY:
Rheumatoid factors are a group of antibodies directed to determinants in the ADDITIONAL EQUIPMENT:
Fc portion of the immunoglobulin G molecule. Although rheumatoid
factors are found in a number of rheumatoid disorders, such as systemic 1.Thermostatic bath at 37˚C
lupus erythematosus (SLE) and Sjö gren’s syndrome, as well as in 2.Spectrophotometer or photometer thermostable at 37˚C with a 650 nm filter
nonrheumatic conditions, its central role in clinic lies its utility as an aid in the (600 – 650 nm).
diagnosis of rheumatoid arthritis (RA). A study of the “American College of
Rheumatology” shows that the 80.4% of RA patients were RF positive.
SAMPLES:
PRINCIPLE:
Fresh serum or plasma. Stable 7 days at 2-8˚C or 3 months at –20˚C.
The RF-Turbilatex is a quantitative turbidimetric test for the measurement of The samples with presence of fibrin should be centrifuged before
RF in human serum or plasma. Latex particles coated with human testing. Do not use highly hemolized or lipemic samples
gammaglobulin are agglutinated when mixed with samples containing RF. The
agglutination causes an absorbance change, dependent upon the RF contents of GENERAL SYSTEM PARAMETER:
sample that can be quantified by comparison from a calibrator of known RF
concentration. Two
Reaction
point /Fixed Sample Vol. 5 µl
Mode
COTENTS: Time
650 (600- 400 µl(A1) +
Wavelength Reagent vol.
650 nm) 100 µl(A2)
PACK SIZE DILUENT (A1) LATEX(A2) CALIBRATOR
Distilled
Blank Calibrator Conc See vial Label
2x25ml 2x20ml 2x5ml 1x2ml water
Incubation 37˚C Reaction Slope Increasing
Delay Time 10 sec Linearity 100 IU/ml

PRECAUTIONS:
Read Time 120 sec Units IU/ml
Components from human origin have been tested and found to be negative for
the presence of HBsAg, HCV, and antibody to HIV (1/2). However handle ASSAY PROCEDURE:
cautiously as potentially infectious.
1.Bring the reagents and the photometer (cuvette holder) to 37˚C.
CALIBRATION: 2.Assay conditions:
Wavelength : 650 nm (600-650 nm)
Use CHEMLEON RF Calibrator ONLY. Temperature : 37 ˚C
The sensitivity of the assay and the target value of the calibrator have been Cuvette ligth path : 1cm
standardized against the International Reference Standard from NIBSC 3.Adjust the instrument to zero with distilled water.
64/002. Recalibrate when control results are out of specified tolerances, when 4. Pipette into a cuvette: Working Reagent(400µl(A1)+100µl(A2))
using different lot of reagent and when the instrument is adjusted. 5.Mix and read the absorbance (Blank reagent).
6.Add the sample/ calibrator.
PREPARATION:
Sample Preparation Reagent Blank Test
RF Calibrator: Reconstitute with 2.0 ml of distilled water. Mix gently and Diluent(A1) 400 µl 400 µl
bring to room temperature for about 10 minutes before use. Latex(A2) 100 µl 100 µl
NaCl 9 g/L 5 µl -
Calibration Curve: Prepare the following RF calibrator dilutions in NaCl 9 g/L. Calibrator/Sample - 5µl
Multiply the concentration of the RF calibrator by the corresponding factor
stated in table bellow to obtain the RF concentration of each dilution 6.Mix and read the absorbance after 2 minutes Abs (A2) of the sample addition.
Calibrator Dilution 1 2 3 4 5 6
Calibrator RF(µl) - 25 50 100 200 400 CALCULATIONS:
NaCl g/l (µl) 400 375 350 300 200 -
Factor 0 0.0625 0.125 0.25 0.5 1.0 (A2-A1) sample
RF IU/L= × Calibrator Concentration
STORAGE AND STABILITY: (A2-A1) calibrator
OR
All the components of the kit are stable until the expiration date on the label Calculate the absorbance difference (A2-Ablank reagent) of each point of the
when stored tightly closed at 2-8˚C and contaminations are prevented during calibration curve and plot the values obtained against the RF concentration of
their use. Do not use reagents over the expiration date. each calibrator dilution. Rheumatoid Factor concentration in the sample is
calculated by interpolation of its (A2-Ablank reagent) in the calibration curve.
Reagent deterioration: Presence of particles and turbidity.
Reconstituted calibrator: Stable for 1 month at 2-8˚C or 3 months at –20˚C. REFERENCE VALUES:
Do not freeze the kit ; frozen latex and diluent could change the functionality of
the test. Normal values up to 20 IU/mL Each laboratory should establish its own
reference range.
PERFORMANCE CHARACTERISTICS
1. Limit detection: Values less than 6 IU/mL give non- REFERENCES:
reproducible results. 1. Frederick Wolfe et al. Arthritis and Rheumatism 1991; 34: 951- 960.
2. Measurement range: 6-100 IU/mL, under the described assay conditions. 2. Robert W Dorner et al. Clinica Chimica Acta 1987; 167: 1-21.
Samples with higher concentrations should be diluted 1/5 in NaCl 9 g/L and
3. Robert H Shmerling et al. The American Journal of Medicine 1991; 91: 528
retested again
The linearity limit and measurement range depends on the sample to – 534.
reagent/ratio, as well as the analyzer used. It will be higher by decreasing the 4. Vladimir Muié et al. Scand J Rheumatology 1972; 1: 181 – 187.
sample volume, although the sensitivity of the test will be proportionally 5. Paul R et al. Clin Chem 1979; 25/11: 1909 – 1914.
decreased.
6. Young DS. Effects of drugs on clinical laboratory test, 4th ed. AACC Press,
3. Prozone effect: No prozone effect was detected upto 800 IU/mL
4. Sensitivity: 3.34 mA. IU/mL. 1995
5. Precision: The reagent has been tested for 20 days, using three different RF
concentrations in a study.
NOTES
1. Clinical diagnosis should not be made on findings of a single test result, but
should integrate both clinical and laboratory data.

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Delay Time 10 sec Linearity 100 IU/ml

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