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PRODUCT
ELITex Bicolor RF
Latex slide agglutination test for the detection of Rheumatoid Factor in serum samples.
ELITex Bicolor RF is a latex slide agglutination test for the rapid qualitative or semi-quantitative detection of IgM Rheumatoid Factor in serum.
- 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 |
| 04165 / 04166 | ELITex Bicolor RF | 50 / 100 tests |
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Benefits
Intended use
The Rheumatoid Factor is a high diagnostic interest biological marker for adult rheumatoid arthritis. ELITex Bicolor RF is a latex slide agglutination test for the rapid detection of Rheumatoid Factor in serum samples.
Principle
ELITex Bicolor RF is an agglutination slide test. It consists of latex particles allowing the rapid qualitative or semi-quantitative detection of IgM Rheumatoid Factor in sera from most of patients with rheumatoid arthritis. The TEST LATEX is constituted by latex particles sensitized by human gamma-globulins, which agglutinate specifically Rheumatoid factor (FII-type reaction). The presence of Rheumatoid Factor in sera is revealed by a red agglutination on a more or less intense blue background, visible to the naked eye. Otherwise, no agglutination is observed and the suspension remains homogeneous with a uniform purple color. Handling is simple and fast. It is performed on pure serum and the 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_methodo1.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_results1.jpg)
Reagents and Material
| Quantity | Description |
| 1 | TEST LATEX: Dispenser vial containing 2.5 mL of sensitized latex |
| 1 | CONTROL +: Dispenser vial containing 0.2 mL of positive control |
| 1 | CONTROL -: Dispenser vial containing 0.2 mL of negative control |
| 5 | TEST CARD: Disposable reaction cards |
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 369 human negative sera and 80 human positive sera.
| Sensitivity | Specificity |
| 98.75% | 98.37% |
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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