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Rapid immunochromatographic test for the detection of the total Ig antibodies specific to Borrelia burgdorferi in serum.
| - RELIABLE : |
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- Quality system certified ISO 9001 and ISO 13485,
- Sensitivity (*) :
-------- Global sensitivity = 28/35 = 80%,
-------- Early stage sensitivity = 3/5 = 60%,
-------- Secondary stage sensitivity = 16/21 = 76% (*),
-------- Late stage sensitivity = 5/5 = 100%.
- Specificity : 94% on a population of healthy blood donors.
(*) - Evaluation carried out at the Faculty of Medicine of Cochin Paris - February 2005.
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| - EFFICIENT : |
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- Qualitative and quantitative results,
- Use of a mixture of native antigens (B31 strain) and recombinant proteins (proteins OspC, BmpA and p88/100 of the B31 strain),
- Detection of total Ig,
- Rapid : results in 10 to 20 minutes.
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| - PRACTICAL : |
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- Simple : one step test,
- Traceability : possible filing of the device,
- Long shelf life : 12 months,
- Packaging presentation : 10 tests/kit.
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INTRODUCTION
Lyme disease is a tick-borne disease caused by the spirochete Borrelia burgdorferi. This disease is well known to affect men as well as mammals including dogs, cats and horses. The disease can be diagnosed thanks to clinical symptoms and to the elevation of Borrelia burgdorferi antibodies in serum.
There are several stages of disease :
- Localized Early (Acute) Stage : Erythema Migrans (EM), an erythemous annular border that gradually expands with partial central clearing.
- Early Disseminated Stage : signs of neurologic, cardiac or articular involvement.
- Late Stage : Untreated or inadequately treated patients may experience late persistent disease with rheumatologic or dermatologic symptoms.
Within 3 to 6 weeks, Borrelia burgdorferi antibodies are produced and keep increasing for several months. A serologic testing in Lyme disease can be performed to detect Borrelia burgdorferi antibodies in serum.
INTERPRETATION
LYMETOP+ ® is a rapid immunochromatographic test for detection of total Ig antibodies against 3 species of Borrelia burgdorferi (B. burgdorferi sensu stricto, B. afzelii and B. garinii).
IgG appear about 10 weeks after the infection. IgG are absent in 50% of cases in the early stage. Their rate increase in the secondary stage and they are always present in the tertiary stage. They can be detected as long as the symptoms persist. IgM can be detected quickly (about 2 weeks after the infection). Their rate decrease quickly and they are not constantly present in the secondary and tertiary stages.
If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not, at any time, proclude the possibility of Borrelia burgdorferi infection.
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