The Leishmania IgG/IgM Combo Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM to the subspecies of the Leishmaniadonovani (L. donovani), the Visceral leishmaniasis causative protozoans, in human serum, plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of the disease of Visceral leishmaniasis. Any reactive specimen with the Leishmania IgG/IgM Combo Rapid Test must be confirmed with alternative testing method(s).