RF LATEX

Intended Use:

Test for qualitative determination of Rheumatoid Factors (RF) by immune agglutination method.

Introduction:

Rheumatoid factors are a group of antibodies directed to determinants in the Fc portion of the immunoglobulin G molecule. Although rheumatoid factors are found in a number of rheumatoid disorders, such as systemic lupus erythematosus (SLE) and Sjogren’s syndrome, as well as in nonrheumatic conditions, its central role in clinic lies its utility as an aid in the diagnosis of rheumatoid arthritis (RA). A study of the ‘American College of Rheumatology’, shows that the 80.4% RA patients were RF positive.

RF Latex Test Procedure

Principle:

The RF-Latex is a slide agglutination test for the qualitative and semi-quantitative detection of RF in human serum. Latex particles coated with human gammaglobulin are agglutinated when mixed with samples containing RF.

Kit Components

Latex Reagent – 1 Bottle.
Positive Control – 1 Bottle.
Negative Control – 1 Bottle.
Mixing Sticks.
Sample Droppers.
Glass Slide.
Instructions for Use.

Specification

Procedure Qualitative only (Slide Test) and Semi-quatitative method (Slide Test)
Procedure Time 2 minutes for Qualitative as well as Semi-Quantitative Method
Analytical Sensitivity 6 IU/mL
Sample Type Fresh Serum
Prozone Effect Not detected upto 800 IU/mL.
Pack Sizes 25 Test
50 Test
100 Test.
Storage Temperature 2- 80C
Shelf life 18 months
Kit dimensions 25 test – 85x105x145 mm.
50 test – 85x105x145 mm.
100 test – 85x105x145 mm.
Approx. weight of kit 25 test – 64 gms.
50 test- 86 gms.
100 test – 96 gms.
Production Capacity 600 mn ml per annum