Performance of Latex Agglutination Test (KAtex) In Diagnosis of Visceral Leishmaniasis in Iran

Background: Visceral leishmaniasis (VL) is an endemic disease in some parts of Iran. Many techniques have been used for diagnosis of VL, among which the urine based latex agglutination test (KAtex) is a promising one. Objective: To compare three diagnostic tests of VL including KAtex, ELISA and Direct Agglutination Test (DAT) in VL patients and healthy controls in the south west of Iran. Methods: Serum (n = 29) and urine samples (n = 31) were collected from parasitologically confirmed VL patients. Control samples were obtained from healthy individuals (n = 61) and also from patients with infectious diseases other than VL. The collected serum samples were tested by DAT and ELISA using crude antigen from promastigotes of Leishmania infantum and the urine samples were tested by KAtex. Results: Sensitivity and specificity of KAtex for diagnosis of VL was found to be 83.9% and 100%, respectively. Sensitivities of DAT and ELISA were 93.1% and 86.2% and their specificities were 100% and 90.5%, respectively. Conclusion: KAtex yielded a satisfactory sensitivity and specificity in diagnosis of VL in Iran and can be recommended as a rapid, field applicable and reliable test for diagnosis of VL in this region.