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PRODUCT
WAALER-ROSE Bicolor
Haemagglutination slide test for the detection of Rheumatoid Factor in serum samples.
WAALER-ROSE Bicolor is a haemagglutination slide test for the rapid qualitative and semi-quantitative détection of IgM Rheumatoid Factor in sera from most patients with rheumatoid arthritis.
- Simple visual reading, without expert interpretation: bi-colored latex reaction
- Fast results for clinicians (2 minutes)
- Cost-effective, routine laboratory test
- Easy and ready-to-use
- High sensitivity and specificity
Finally, our kit meets all safety requirements with positive and negative controls.
| Reference | Name | Quantity |
| 04175 / 04176 | WAALER-ROSE Bicolor | 50 / 100 tests |
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Benefits
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
![elitex_bicolor_fr_waaler_rose_methodo[1]](http://www.elitechgroup.com/wp-content/uploads/2015/01/elitex_bicolor_fr_waaler_rose_methodo11.jpg)
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:
| Positive + | Negative – | |
| Result | Formation of red agglutinates on a more or less blue intense background | No agglutination. The suspension remains homogeneous and purple |
| Interpretation | Presence of Rheumatoid Factor | Absence of Rheumatoid Factor |
![elitex_bicolor_rf_waaler_rose_results[1]](http://www.elitechgroup.com/wp-content/uploads/2015/01/elitex_bicolor_rf_waaler_rose_results11.jpg)
Reagents and material
| Quantity | Description |
| 1 | TEST LATEX: Dispenser vial containing 2.5 mL of sensitized latex. |
| 1 | CONTROL +: Dispenser vial containing 0.3 mL of positive control. |
| 1 | CONTROL -: Dispenser vial containing 0.3 mL of negative control. |
| 5 | TEST CARDS: Disposable reaction cards. |
| 50 | STICKS: Disposable stirrers. |
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
The performance study has been made on 1651 human negative sera and 248 human positive sera.
| Sensitivity | Specificity |
| 98.79% | 98.79% |
Material required but not provided
- Automatic pipette(s) with a pipetting volume adapted to the volume that will be measured
- Haemolysis tubes
- Physiological water
- Contaminated waste container
Manufacturer: ELITech Microbio.
Product(s) intended for healthcare professionals.
Read the instructions on the label and/or instructions for use of the product(s).
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