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Haemagglutination slide test for the detection of Rheumatoid Factor in serum samples.
Intended use
The Rheumatoid Factor is a high diagnostic interest biological marker for adult rheumatoid arthritis.
WAALER-ROSE Bicolor is a haemagglutination slide test for the rapid detection of Rheumatoid Factor in serum samples.
Principle
WAALER-ROSE Bicolor is based on the Rheumatoid Factor specific haemagglutination properties, used in reactions of the Waaler-Rose type.
REAG is composed of sheep red blood cells sensitized by gamma globulins fraction of rabbit anti-sheep red blood cells serum.
The presence of Rheumatoid Factor in serum sample is revealed by haemagglutination on a blue background, visible to the naked eye. Otherwise, no agglutination is observed and the suspension remains homogeneous and an uniform green-brown color.
Handling is simple and fast. It is performed on pure serum and he results are obtained in 2 minutes.
Simple protocol
Easy-to-read and easy-to-interpret results
The kit contains an internal quality control which allows observing a positive and a negative reaction as described below:
| Result | Interpretation |
| +: Formation of red agglutinates on a more or less blue intense background | Presence of Rheumatoid Factor |
| -: No agglutination. The suspension remains homogeneous and purple | Absence of Rheumatoid Factor |
Reagents and material
Stability and storage
All reagents are ready-to-use.
Reagents stored at 2-8°C, in their original state, are stable up to the expiry date indicated on the box.
They must not be frozen.
The shelf life of the product, from its manufacture, is 24 months.
Performance
A study made on 1651 human negative sera and 248 human positive sera has demonstrated that the test WAALER-ROSE Bicolor has a sensitivity of 98.79% and a specificity of 98.79%.
Material required but not provided
