NCT01769612

Evaluation of a Rapid Diagnostic Device, CL Detect, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia

Evaluation of a Diagnostic Device, CL Detect Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 168 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the sensitivity and specificity of CL Detect, in subjects with suspected CL in Tunisia.

Detailed description

Subjects were selected based on clinical appearance of the skin lesion characteristics of cutaneous leishmaniasis (CL). Study compared the CL Detect Rapid Test vs microscopic identification of Leishmania amastigotes in a stained lesion sample. Two diagnostic samples were collected from the subjects lesion in the following order: 1) obtained with a dental broach for use with the CL Detect Rapid Test and 2) a second sample was obtained by scraping for use in the microscopic identification of amastigotes. Samples were analyzed by microscopy and CL Detect Repaid Test by different operators who evaluated each sample independently blinded to the other assay result.

Conditions

• Skin Diseases, Parasitic

Interventions

Type	Name	Description
OTHER	No Intervention

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-08-01
• Completion: 2014-04-01
• First posted: 2013-01-16
• Last updated: 2017-06-20
• Results posted: 2017-06-20

Locations

2 sites across 1 country: Tunisia