Comparative evaluation of ELISAs based on ten recombinant or purified Leishmania antigens for the serodiagnosis of Mediterranean visceral leishmaniasis.

This study compared a panel of 10 enzyme-linked immunosorbent assays (ELISAs) for the serodiagnosis of Mediterranean visceral leishmaniasis (MVL). The ELISAs were based on either one of the following Leishmania antigens: crude soluble Leishmania antigens (SLAs), recombinant (r) antigens (namely: rgp63, rK39, gene B protein, r H2A and r H2B histones proteins, rLACK, rPSA-2, r P20) and purified lipophosphoglycan. Most of the test antigens showed good performance (sensitivity > 85%, specificity > 80%). rK39 and SLA-based ELISA gave the best results in terms of sensitivity (100%) and predictive value of the negative (100%). The best specificity (97%) and the best predictive value of the positive (92%) were obtained with rK39. These results show that several Leishmania antigens are suitable to design a diagnostic ELISA of MVL. However, recombinant proteins add little to the classic crude SLA, which still represents a very good and less costly alternative.