A comparative study of antigen and antibody detection in visceral leishmaniasis using serum and urine-based ELISA.

An antigen-based ELISA system was evaluated for diagnosis of visceral leishmaniasis (VL). Urine samples from confirmed VL cases were tested by the system in comparison with urine samples from patients with non-VL infectious disease and patients with non-infectious diseases. Antigen was detected in urine of 21 out of 35 (60%) of VL cases. No cross reaction was found with samples from healthy individuals except in 3 samples from non-VL infectious diseases. Two samples from cutaneous leishmaniasis patient and one from patient with toxoplasmosis. The results obtained with the antigen-based ELISA were compared to those obtained with direct agglutination test (DAT), an antibody-based ELISA and indirect immunofluorescent antibody (IFA) revealed that the antigen-based ELISA is comparable in terms of specificity (91.2%; 95% CI=75.2-97.7%) but with a lower sensitivity (60%; 95% CI=42.2-75.6%). These results suggest that the antigen detection in urine by the noninvasive antigen-based ELISA system might offer a useful method for diagnosis of VL.