Leishmania donovani: titration of antibodies to the fucose-mannose ligand as an aid in diagnosis and prognosis of visceral leishmaniasis.

The fucose-mannose ligand (FML) is a complex glycoprotein fraction present on promastigotes and amastigotes of Leishmania donovani. It participates in parasite interaction with host macrophages in a species-specific pattern. We have tested its use in immunodiagnosis of visceral leishmaniasis (VL) in a recent outbreak in Rio Grande do Norte, north-east Brazil. Enzyme-linked immunosorbent assay (ELISA) of low concentrations of FML in 462 sera showed 100% sensitivity and 96% specificity. The FML-ELISA identified patients with overt VL (P < 0.001, compared to normal sera). It could also identify inhabitants of the endemic area who had incipient or subclinical infection with potentially severe clinical disease: more than 20% of apparently healthy subjects with a positive ELISA for FML developed overt VL during the following 10 months. FML-ELISA reactivity decreased in all patients during treatment, and became negative after parasitological cure. No cross-reaction was observed in patients infected with other Leishmania species, nor in those with Chagas disease. Determination of antibody response to FML may be useful in diagnosis of VL and in identifying patients without overt disease but with a high risk of developing severe VL.