A urine-based polymerase chain reaction method for the diagnosis of visceral leishmaniasis in immunocompetent patients.

In the Mediterranean basin and Middle East, including Iran, visceral leishmaniasis (VL), also known as kala-azar, is caused by Leishmania donovani infantum. For the first time, the use of urine samples for the diagnosis of VL in immunocompetent patients has been used in this study. Based on its high sensitivity and specificity, as well as simplicity, this approach can serve as a valuable tool in the diagnosis of VL. We studied 60 urine samples from 60 individuals, 30 of which were patients with VL confirmed by parasitology, serology, or molecular methods, 5 were from healthy individuals, and 25 were from patients with cutaneous leishmaniasis, malaria, brucellosis, and hydatid cyst. Out of 30 samples from confirmed VL immunocompetent patients, 29 were positive (sensitivity, 96.8%) by polymerase chain reaction (RV1 and RV2 primers), and all the remaining 30 samples either from healthy individuals or patients with other diseases were negative (specificity, 100%). High sensitivity, specificity, and simplicity of the test can serve as a valuable tool in the diagnosis of VL.