Expected use
The Leishmania IgG / IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM of the subspecies of Leishmania donovani (L. donovani), the protozoa that cause visceral leishmaniasis, in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of visceral leishmaniasis disease. Any specimen reactive with the Leishmania IgG / IgM Rapid Test should be confirmed by alternative test methods.
Summary and explanation
Visceral leishmaniasis, or Kala-azar, is a disseminated infection caused by various subspecies of L. donovani. The World Health Organization (WHO) estimates that the disease affects approximately 12 million people in 88 countries. It is transmitted to humans by the bite of sandflies, which acquire the infection by feeding on infected animals. Although it is a disease found in poor countries, in southern Europe, it has become the main opportunistic infection in AIDS patients. Identification of the L. donovani organism from blood, bone marrow, liver, lymph nodes, or spleen provides a definitive means of diagnosis.
Serological detection of anti-L. donovani IgM is an excellent marker of acute visceral leishmaniasis. Tests used in the clinic include ELISA, fluorescent antibodies, or direct agglutination tests. Recently, the use of L. donovani specific protein in the test has dramatically improved sensitivity and specificity. The Leishmania IgG / IgM Rapid Test is a recombinant protein-based serological test that detects IgG and IgM antibodies against L. Donovani simultaneously. The test provides a reliable result in 10 minutes without any instrument.
