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

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

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.

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