Leishmania are protozoan parasites of worldwide distribution. They cause a variety of human diseases affecting at least 150 million people. At the present time, no effective or standardized diagnostic tests are available, although they are greatly needed for disease management. The activities proposed in this application have been designed to produce and apply a recombinant Leishmania antigen, termed rK39, as an immunodiagnostic test for Leishmania donovani, which causes the fatal visceral form of leishmaniasis. The available evidence would support the conclusion that this recombinant antigen can serve as a sensitive and specific serodiagnostic antigen that can distinguish infection with L. donovani from other diseases with similar symptoms. In the proposed continuation of this Small Business Initiate Research (SBIR), recombinant antigens and possible synthetic peptides will be evaluated in ELISA and rapid test formats using sera from patients documented to have visceral leishmaniasis, and results will be compared with sera from patients with other infections. These studies will allow and facilitate the production of kits for the serological diagnosis of visceral leishmaniasis. The tests are designed for both clinical and veterinary application, and for laboratory and field use. The tests will be evaluated comparatively in multi-center clinical trials.
