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

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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.

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Data Availability

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

The authors gratefully appreciate the financial support provided by the Tehran University of Medical Sciences (with approval number: TUMS240/536) and Research and Training in Skin Diseases and Leprosy (CRTSDL).

Funding

This research supported by the Tehran University of Medical Sciences (Approval number: TUMS240/536).

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Authors and Affiliations

  1. Department of Medical Parasitology and Mycology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran

    Maryam Zamanpour, Mehdi Mohebali & Behnaz Akhoundi

  2. Department of Medical Parasitology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

    Maryam Zamanpour

  3. Center for Research of Endemic Parasites of Iran (CREPI), Tehran University of Medical Sciences, Tehran, Iran

    Mehdi Mohebali

  4. Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran

    Ali Khamesipour & Akram Mir Amin Mohammadi

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  1. Maryam Zamanpour
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  2. Mehdi Mohebali
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  4. Akram Mir Amin Mohammadi
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  5. Behnaz Akhoundi
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Corresponding authors

Correspondence to Mehdi Mohebali or Ali Khamesipour.

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Conflict of Interest

The authors declared no conflict of interest.

Ethical Approval

The research proposal was approved by Ahvaz Jundishapur University of Medical Sciences Ethical committee (Approval number: IR.AJUMS.ABHC.REC.1399.028) and the patients who were enthusiastic to take part and sign informed consents were recruited.

Human and Animal Rights

No animals were used in this study. All human research procedures were in accordance with the standards set forth in the Declaration of Helsinki https://www.wma.net/policiespost/wmadeclarationof-helsinki-ethical principles for medical research-involving animals subjects/principles of 1975, as revised in 2008 (http://www.wma.net/en/20activities/10ethics/10helsinki/).

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Zamanpour, M., Mohebali, M., Khamesipour, A. et al. Diagnosis of Human Cutaneous Leishmaniasis: A Comparative Study Using CL Detect™ Dipstick, Direct Smear and Polymerase Chain Reaction Methods. Acta Parasit. 68, 328–333 (2023). https://doi.org/10.1007/s11686-023-00662-5

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  • DOI: https://doi.org/10.1007/s11686-023-00662-5

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