Leishmania IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM to the subspecies of the Leishmania donovani (L. donovani), the Visceral leishmaniasis causative protozoans, in human whole blood, serum or plasma. 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 Rapid Test must be confirmed with alternative testing method(s).