Evaluation of a Diagnostic Device, CL Detect Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 168
- Locations
- 2
- Primary Endpoint
- Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •At least 18 years of age and generally healthy
- •Subject able to give written informed consent
- •Subject has a lesion suspicious for leishmaniasis that satisfies the following criteria for an index lesion:
- •less than 4 months in age
- •primarily ulcerative, ie not purely verrucous or nodular, and does not have clear clinical evidence of cellulitis
- •in a location suitable for collecting samples by dental broach, scraping, and aspiration
- •In the opinion of the investigator, the subject is capable of understanding and complying with the protocol
Exclusion Criteria
- •Received treatment for leishmaniasis within the last 2 months prior to signing consent, with the exception of mercurochrome
Outcomes
Primary Outcomes
Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results
Time Frame: within 1 hour after taking samples
Comparison of CL Detect Rapid Test positive results with Microscopy and Culture results. Note: only data where results for all three methods were available were included in the analysis.
Secondary Outcomes
No secondary outcomes reported