Leishmania IgG/IgM Rapid Test
This Leishmania antibody rapid test kit is used as an aid in the diagnosis of Visceral leishmaniasis, A.K.A. Kala-Azar Disease.
Intended Use
Leishmania IgG/IgM Rapid Test Kit is a lateral flow immunoassay for the simultaneous detection and differentiation of the IgG and IgM antibodies to the Leishmania donovani (L.donovani) in human serum or plasma. This Leishmania blood test is intended to be used as a blood screening test and as an aid in the diagnosis of the disease of Visceral leishmaniasis, A.K.A. Kala-Azar Disease. Any reactive specimen with this Leishmania rapid Test kit must be confirmed with alternative testing method(s) together with other clinical diagnosis.
Reagents Used in the Kit
The Leishmania IgG/IgM Rapid Test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant L.donovani antigen conjugated with colloid gold (Leishmania conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test bands (1 and 2 bands) and a control band (C band). The band 1 is pre-coated with monoclonal anti-human IgM for the detection of anti-L.donovani IgM, band 2 is pre-coated with reagent for the detection of anti-L.donovani IgG, and the C band is pre-coated with goat anti rabbit IgG.
Leishmaniosis Disease
Visceral leishmaniosis, or Kala-azar, is a disseminated infection caused by several subspecies of L.donovani. It is transmitted to humans by bites of the Phlebotomus sandflies, which acquire infection from feeding on infected animals.
Serological detection of anti-L.donovani IgM is found to be an excellent marker for the acute Visceral leishmaniasis. Recently, the adoption of L. donovani specific protein in the serological test method has improved the sensitivity and specificity dramatically.