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The diagnostic potential of recombinant Lepp12 (rLepp12) antigen cloned from Leishmania infantum was assessed in L. donovani infections by Western blotting. Ninety-two serum samples, including 30 patients with active kala-azar (KA), 17 post-treated KA patients (KA-PT), 20 post-kala-azar dermal leishmaniasis (PKDL) patients and 25 controls, were analysed for rLepp12, rK39 and DAT positivity. All KA samples taken at pre-treatment stage were positive for Lepp12 antibodies. Seventeen of these were evaluated post treatment (KA-PT), 10 of which were found to be negative. Nine of these 10 negative cases corresponded to clinically cured patients with regressed spleen. Seven post-treatment cases were rLepp12-positive; all of them corresponded to patients who were considered clinically cured but continued to have an enlarged spleen (> or =5 cm). The majority of PKDL patients (18/20) were found to be seronegative by immunoblot test using rLepp12 antigen. The rLepp12-based Western blot diagnosed 100% of patients with visceral disease, whilst none of the control cases were found to be reactive to rLepp12. rLepp12 protein provides a useful reagent for highly sensitive and specific diagnosis of KA. Additionally, rLepp12 appears to have potential as a prognostic marker for the infection.
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Kumar et al. (2008) studied this question.
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