RF-TURBILATEX

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Intended Use:

Test for quantitative determination of Rheumatoid Factors by using Latex Turbidimetric method.

Summary:

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.

Principle:

The RF-Turbilatex is a quantitative turbidimetric test for the measurement of RF in human serum or plasma. Latex particles coated with human gammaglobulin are agglutinated when mixed with samples containing RF. The agglutination causes an absorbance change, dependent upon the RF contents of sample that can be quantified by comparison from a calibrator of known RF concentration

Specification

Methodology Immunoturbidimetry
Reaction Type Kinetic
Reaction Direction Increasing
Sample Type Human Serum or Plasma
R1:R2 Mixing Ratio 4:1
Primary Wavelength 540 nm
Secondary Wavelength NA
Blank Settings Distilled Water
Blank Absorbance Limit <0.300
Reagent Volume Required Per Test 1000 µl
Sample Volume Required Per Test 7 µL
Delay Time 10 seconds
Calibrator Available in the Kit Yes
Factor NA
Linearity 160 IU/ml.
Automation Enabled
Pack Sizes 1×50 ml
Kit components Reagent bottles – R1 and R2.
1 Calibrator vial.
Instructions for Use.
Storage Temperature 2- 80C
Shelf life 24 months
Kit dimensions 1×50 ml – 85x105x45 mm
Approx. weight of kit 1×50 ml – 130 gms
Production Capacity 600 mn ml per annum