Urine antigen detection by latex agglutination test for diagnosis and assessment of initial cure of visceral leishmaniasis.

This prospective study evaluated the usefulness of the kala-azar latex agglutination test (KAtex) for the diagnosis and laboratory assessment of initial cure of visceral leishmaniasis (VL) (or kala-azar) patients following 30 days of sodium antimony gluconate treatment at Rajshahi Medical College Hospital (Bangladesh). KAtex detects a low molecular weight, heat-stable, carbohydrate antigen in the urine of VL patients. KAtex was performed using freshly voided urine samples obtained from 36 parasitologically confirmed cases of VL before and after treatment as well as from 40 healthy controls (20 each from kala-azar-endemic and non-endemic zones). KAtex was found to be positive in 27 (75%) of the 36 patients at diagnosis and was negative in all the controls. The diagnostic sensitivity and specificity of KAtex were 75% (95% CI 57-87%) and 100% (95% CI 89-100%), respectively. Following treatment, all 36 VL cases were negative for Leishman-Donovan bodies by splenic smear microscopy and 34 (94.4%) were negative by KAtex. This limited study suggests that KAtex is a satisfactorily sensitive, highly specific, rapid and completely non-invasive urine-based antigen detection test for the diagnosis of VL. Currently, this is the only non-invasive laboratory tool useful for the assessment of initial cure in VL patients.