Evaluation of latex agglutination test (KATEX®) for the detection of urinary antigens in human visceral leishmaniasis

Background and Aim: In this study, we compared a latex agglutination test (KatexR) with the direct agglutination test (DAT) for the diagnosis of human visceral leishmaniasis (HVL) in an area with a high prevalence of zoonotic visceral leishmaniasis (ZVL) in Iran. Materials and Methods: The validity of the KatexR (Kalon Biological Ltd, England) for detection of urinary Leishmania antigens in HVL was compared with standard direct agglutination test on 92 visceral leishmaniasis patients (29 were acute and 65 were chronic phase) and 90 healthy controls over a period of one year. Results: We detected a sensitivity of 82.7% and a specificity of 98.9% in the acute phase. As for the chronic phase, the test showed a sensitivity of 6.15% and a specificity of 98.9% at a 1:3200 cut-off titer. Concordance between KatexR and DAT was 94 .9% in the acute phase and 59. 3% in the chronic phase. As the rapid, noninvasive Katex does not require much expertise or elaborate equipment. Conclusion: It can be used for screening and diagnosis of human visceral leishmaniasis in remote endemic foci