Abstract

  Background and Aim: Visceral leishmaniasis is endemic at least in three provinces of our country, Iran, including Ardabil, Fars and East Azarbayejan. The disease is of Mediterranean type in Iran and affects mainly children. Therefore, the early diagnosis and treatment of this disease can prevent its high mortality (>95%). Because of the invasion of bone marrow aspiration or biopsy and limitations in the others methods, several studies have been done to use simple tests for the diagnosis of Leishmania infantum in children that KAtex test to detect the urinary antigens is one of them. The aim of this study was to evaluate the efficiency of KAtex test in the diagnosis of visceral leishmaniasis and possible replacement with serological methods (IFA, DAT, Elisa IgG & IgM) in endemic areas.

  Materials and Methods: This was a cross-sectional, descriptive and epidemiologic study which was conducted in Ahar and Kalybar villages of East Azarbayejsn as endemic areas. KAtex kit was used for diagnosis in 72 confirmed and historic Kala-azar patients and for case finding among 313 children in the endemic area of Kalibar & Ahar, East Azerbaijan province, northwest Iran. Results also compared with serologic tests (DAT, IFA, and Elisa- IgG & IgM) to any possible agreement and validity & reliability indexes. Kappa and McNemar were used for data analysis .

  Results: From 385 of urinary samples, 38 (9.8%) were positive by KAtex test. The rapid KAtex test had sensitivity of 77.7% and quite specificity (98.2%) in the diagnosis of human visceral leishmaniasis. Highest and lowest agreement of KAtex test was respectively with Elisa- IgM (kappa = 0.834, Pv= 0.549) and DAT (kappa=0.400, Pv= 0.000). Also this test did not have any cross reaction with tuberculosis, toxoplasmosis and brucellosis patients' urine samples

  Conclusion: The KAtex test is rapid, non-invasive and simple. It does not require much expertise or elaborate equipment and it can be used for the diagnosis of visceral leishmaniasis in remote endemic areas. Also, because KAtex discriminates between active diseases, sub-clinical and past infection, its results can complete DAT for the diagnosis of unconfirmed visceral leishmaniasis cases .