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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03435419

Acronym

CLeishPOCAFG

Enrollment

274

Registered

2018-02-19

Start date

2016-04-16

Completion date

2016-07-18

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Leishmaniases

Keywords

cutaneous leishmaniasis, RDT, LAMP, PCR

Brief 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.

Interventions

DIAGNOSTIC_TESTLoopampTM Leishmania Detection Kit

LoopampTM Leishmania Detection Kit is a diagnostic test for Leishmania DNA detection

DIAGNOSTIC_TESTCL DetectTM Rapid Test

CL DetectTM Rapid Test is a diagnostic test for Leishmania antigen detection

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026