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

Foundation for Innovative New Diagnostics (FIND)

Status: Completed

Conditions: Cutaneous Leishmaniases

Treatments: Diagnostic Test: LoopampTM Leishmania Detection Kit; Diagnostic Test: CL DetectTM Rapid Test

Study type: Observational

Funder types: Other

Identifiers

NCT03435419

P08020-AFG

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 274 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

274 participants in 1 patient group

CL suspects

Description:

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.

Treatment:

Diagnostic Test: CL DetectTM Rapid Test

Diagnostic Test: LoopampTM Leishmania Detection Kit