Evaluation of Point-of-care Tests for the Diagnosis of Cutaneous Leishmaniasis in Afghanistan

Study Overview
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Brief Summary
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New point-of-care (POC) tests are needed and assessing the performance of these tests for cutaneous leishmaniasis (CL) in Afghanistan may help increasing the number of CL patients with access to accurate diagnosis, and enable prompt treatment. Simpler tests could improve treatment access and benefit patients and communities, by reducing the risk of sequelae and the risk of disease transmission. CLeishPOCAFG aims to advance the diagnosis of CL by using more accurate and field-amenable methods.

Detailed Description
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The investigators enrolled 274 CL suspects in the study to determine the diagnostic performance of LoopampTM Leishmania Detection Kit and CL DetectTM Rapid Test for CL diagnosis in Afghanistan. The study was conducted at the National Malaria & Leishmaniasis Control Program (NMLCP) Leishmaniasis Clinic in Kabul, Afghanistan.

Official Title
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Point of Care Tests for Cutaneous Leishmaniasis: Prospective Evaluation of LoopampTM and CL DetectTM Rapid Test for Cutaneous Leishmaniasis Diagnosis in Afghanistan

Conditions
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Cutaneous Leishmaniases

Intervention / Treatment
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* Diagnostic Test: LoopampTM Leishmania Detection Kit
* Diagnostic Test: CL DetectTM Rapid Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical signs compatible with cutaneous leishmaniasis Age ≥ than two years old. Informed consent obtained and documented. Clinical samples can be obtained. Exclusion Criteria: Age less than two years old. Failure to obtain and document informed consent. Cutaneous leishmaniasis suspects from whom, for any reason, the required clinical samples needed for the study cannot be obtained. Patients already receiving CL treatment at the time of enrolment.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CL suspects<br>Individuals with suggestive signs of cutaneous leishmaniasis presenting themselves at the National Malaria & Leishmaniasis Control Program (NMLCP) Leishmaniasis clinic in Kabul, Afghanistan. These will be tested by diagnostic tests under evaluation: i) LoopampTM Leishmania Detection Kit is a diagnostic test for Leishmania DNA detection ii) CL DetectTM Rapid Test is a diagnostic test for Leishmania antigen detection And their performance compared against a reference combining microscopy and PCR. | Diagnostic Test: LoopampTM Leishmania Detection Kit<br>* LoopampTM Leishmania Detection Kit is a diagnostic test for Leishmania DNA detection<br>Diagnostic Test: CL DetectTM Rapid Test<br>* CL DetectTM Rapid Test is a diagnostic test for Leishmania antigen detection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of CL Detect RDT and Loopamp Leishmania Detection Kit | Sensitivity and Specificity of the two diagnostic tests | Through study completion, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cutaneous leishmaniasis, RDT, LAMP, PCR