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

Diagnosis of Human Cutaneous Leishmaniasis: A Comparative Study Using CL Detect™ Dipstick, Direct... IntroductionIn 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.MethodsA 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.ResultsOf 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.ConclusionAs 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. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Acta Parasitologica Springer Journals

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

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Publisher
Springer Journals
Copyright
Copyright © The Author(s) under exclusive licence to Witold Stefański Institute of Parasitology, Polish Academy of Sciences 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.
ISSN
1230-2821
eISSN
1896-1851
DOI
10.1007/s11686-023-00662-5
Publisher site
See Article on Publisher Site

Abstract

IntroductionIn 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.MethodsA 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.ResultsOf 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.ConclusionAs 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.

Journal

Acta ParasitologicaSpringer Journals

Published: Mar 13, 2023

Keywords: Cutaneous leishmaniasis; PCR assay; Rapid test; Strips; Direct smear

References