NCT03435419

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 274 (actual)
• Sponsor: Foundation for Innovative New Diagnostics, Switzerland · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Cutaneous Leishmaniases

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	LoopampTM Leishmania Detection Kit	LoopampTM Leishmania Detection Kit is a diagnostic test for Leishmania DNA detection
DIAGNOSTIC_TEST	CL DetectTM Rapid Test	CL DetectTM Rapid Test is a diagnostic test for Leishmania antigen detection

Timeline

• Start date: 2016-04-16
• Primary completion: 2016-06-22
• Completion: 2016-07-18
• First posted: 2018-02-19
• Last updated: 2018-02-19