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RHUMATOP is an immunochromatographic qualitative and semi quantitative detection test for rheumatoid factor in serum.
| - RELIABLE : |
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- Quality system certified ISO 9001 and ISO 13485.
- Specificity : 96 %.
- Sensitivity : 100 %.
(Study done on 152 sera, 40 positive and 112 negative, comparatively to quantitative immuno-enzymatic test)
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| - PACKAGING AND STORAGE : |
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- Réf 5017 : Kit of 50 tests (25 tests Human Ig & 25 tests Animal Ig).
- Réf 5018 : Kit of 50 tests of Rhumatoid Factor directed against Human Ig.
- Réf 5019 : Kit of 50 tests tests of Rhumatoid Factor directed against Animal Ig.
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| - EFFICIENT : |
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- Two detection tests in a same kit :
-------- Rhumatoid Factor directed against Human Ig,
-------- Rhumatoid Factor directed against Animal Ig.
- Detection limit : 12 IU/ml.
- Fast : Results in less than 10 minutes.
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| - PRACTICAL : |
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- 2 Protocols : Qualitative and semi- quantitative.
- One step test.
- Does no need an instrument.
- Objective reading : presence or absence of color bands.
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The rheumatoid factors (RF) are immunoglobulins which are directed against Fc fragments of IgG. Quantification of RF makes it possible to differentiate the rheumatoid arthritis from other articular diseases. Indeed, RF is found in a majority of patients suffering rheumatoid arthritis whereas they are seldom present among patients with other articular diseases.
Although the presence of RF IgM is not specific of rheumatoid arthritis (one also finds them in bacterial infections, hyperglobulinemia or in elderly people), the rheumatoid arthritis is more severe in patients with high and old seropositivity. RF is present in the serum of 70 to 80% of the patients with rheumatoid arthritis. That means that negative result does not mean necessarily the absence of rheumatoid arthritis. It also should be noted, in case of a recent rheumatoid arthritis, that the RF IgM synthesis can have a latency time of 4 weeks or more.
PRINCIPLE
The test is based on immunochromatographic method for detection of RF in the human serum. It is based upon a combination human or rabbit immunoglobulins fixed on the membrane and human or rabbit immunoglobulins marked with latex microparticles.
An initial reaction between a diluted sample of d serum and the immunoglobulin marked with latex takes place in liquid phase. Then the formed complex will migrate along the membrane. The immobilized immunoglobulins on the level of the “T” zone will capture the marked complex which leads to the presence of a blue “T” band (human) or red (animal) according to the concentration of RF in the sample. An internal control line on the level of the “C” zone makes it possible to validate a correct procedure.
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