The Leishmania Rapid Test (Strip) for Visceral Leishmaniasis (VL) is a rapid immunochromatographic strip assay for the qualitative detection of antibodies to members of L. donovani in human serum. The assay is for the aid in the presumptive diagnosis of VL. This test strip is intended for professional in vitro diagnostic use only. It is not intended for use in blood donor centers or blood component manufacturers.
Serum
Strip
90%
Product Introduction
General Description
VL is a severe disease with high mortality, endemic in 88 countries including 17 developed nations.A serious problem in much of the world including Brazil, China, East Africa,India and areas of the Middle East,leishmaniasis is also endemic in the Mediterranean region including southern France,Italy,Greece,Spain,Portugal and Northern Africa. In areas where leishmaniasis is endemic,recent migration patterns of people,vectors (sandfly) and reservoirs(dogs) have led to the urbanization of VL.In Southern Europe,VL has become the leading opportunistic infection in AIDS patients. VL is caused by members of the Leishmania donovani complex and canines have been identified as the major reservoir for transmission 5-8).Serodiagnosis has been widely utilized to establish infection because antileishmanial antibody titers are high during acute disease.The preferred method of diagnosis in a laboratory situation is by ELISA,although fluorescent antibody(IFAT) or direct agglutination tests (DAT), both utilizing whole parasites, are still widely used(9-11).These tests are highly cross-reactive with trypanosomes and mycobacteria.In addition,the whole parasite preparations used are unstable and variable in quality.This rapid assay is for the qualitative determination of antibodies to a recombinant antigen specific for Visceral Leishmaniasis caused by parasite members of the L. donovani complex.
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