1 x 50 / 1 x 20 mL

RF 12006027
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 Intra - Run 5.0 1.0
lupus erythematosus, Chronic hepatopathy etc.
Inter - Run 8.0 5.0
PRINCIPLE
When a sample containing rheumatoid factor is added to denatured human IgG Interference:-
which has been sensitizied to latex particles, antigen-antibody reaction occurs No interference for
leading to agglutination. This agglutination leads to an absorbance change which Hemoglobin 500mg/dL
is measured at (550 to 660nm). The change in absorbance is proportional to Intrafat 5000mg/dL
agglutination and the actual concentration is determined by interpolation from a
calibration curve prepared from known value calibrators. Bilirubin 20mg /dL
REAGENT COMPOSITION BIBLIOGRAPHY
RF R 1 1 x 50 mL Frederick Wolfe et al-Arthritis and Rheumatism 1991 : 34:951-960
Glycine Buffer Solution
RF R2 1 x 20 mL
Latex suspension coated with denatured human IgG
Reagent required but not provided
Agappe RF Calibrator (Product Code: 11617001)

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: 11617001) is recommended for calibration of
this assay.
Preparation of calibration curve:
Prepare the following calibrator dilutions using normal saline 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 - Accute 40 FR Assay Parameter
Dil. factor 0 0.125 0.25 0.5 0.75 1.0 Page 1
Quality Control
Test RF
It is recommended to use Agappe Protein Control (11614005) to verify the
performance of the assay. Each laboratory has to establish its own internal quality Reaction Mode End
control scheme and procedure for corrective action, if controls do not recover with Reference Test ID **
in the acceptable tolerance. Test WL 660
Blank WL NA
Test Read Timing 58-60
Blank Read Timing 36-38
Sample 6 µL
R1 210 µL
R2 70 µL
Stirrer ON
Cal Mode std
Page 3
Calibration Mode Spline
** Not applicable
# - Input Programme Number only for sample Blanking parameters

ADL/V.01/110314