Validação do teste imunocromatográfico rápido IT-LEISH® para o diagnóstico da leishmaniose visceral humana

Abstract

The rapid immunochromatographic test IT-LEISH® (DiaMed IT-LEISH®) was validated for the diagnosis of visceral leishmaniasis (VL) in four endemic areas of Brazil. The performance of the IT-LEISH® was compared with that of the indirect fluorescent antibody test, and that of enzyme-linked immunosorbent assay, using soluble antigen of Leishmania chagasi and the recombinant K39 (rK39). The study group was composed by 332 patients with clinical suspicion of VL: 213 cases confirmed by parasitological tests; and 119 with confirmation of another etiology. The sensitivity of the test IT-LEISH® was of 93% and the specificity of 97%. Immunofluorescent antibody test, ELISA L. chagasi and ELISA rK39 showed sensitivity of 88%, 92%, and 97%, and specificity of 81%, 77%, and 84%, respectively. The results confirm the validity of the test IT-LEISH® for the diagnosis of the VL in Brazil.