Diagnosis of Human Cutaneous Leishmaniasis: A Comparative Study Using CL Detect™ Dipstick, Direct Smear and Polymerase Chain Reaction Methods.

ABSTRACT

INTRODUCTION: In most of the endemic areas, the detection of CL is based on searching for amastigotes using the direct smear method. Since expert microscopists are not usually available in every laboratory, false diagnoses are a disaster that happens. Therefore, the aim of current research is to evaluate the validity of the CL Detect™ Rapid Test (CDRT) for diagnosis CL in comparison to direct smear and polymerase chain reaction (PCR) methods. METHODS: A total of 70 patients with skin lesions suspected to be CL were recruited. Skin samples from the lesions were collected and used for direct microscopic examination and the PCR method. Furthermore, the skin sample was collected in accordance with the manufacturer's instructions for the CDRT-based rapid diagnostic test. RESULTS: Of 70 samples, 51 and 35 samples were positive by direct smear examination and the CDRT, respectively. The PCR showed positive results in 59 samples; 50 and 9 samples were identified as Leishmania major and Leishmania tropica, respectively. The sensitivity and specificity were calculated to be 68.6% (95% CI 54.11-80.89%) and 100% (95% CI 82.35-100%). When the results of CDRT were compared to the microscopic examinations, an agreement of 77.14% was seen between the CDRT and microscopic examination. In addition, the sensitivity and specificity were 59.32% (95% CI 45.75-71.93%) and 100% (95% CI 71.5-100%) when the CDRT was compared to PCR assay (as gold standard) and an agreement (65.71%) was found between CDRT and PCR assay. CONCLUSION: As the CDRT is simple, rapid, and does not require great proficiency, it is recommended for use in the detection of CL caused by L. major or L. tropica as a diagnostic method, especially in areas with limited access to expert microscopists.