Evaluation of the CL Detect Rapid Test in Ethiopian patients suspected for Cutaneous Leishmaniasis.

Background: Cutaneous leishmaniasis (CL) is common in Ethiopia, mainly affecting impoverished populations in rural areas with poor access to health care. CL is routinely diagnosed using skin slit smear microscopy, which requires skilled staff and appropriately equipped laboratories. We evaluated the CL Detect Rapid Test (InBios, Washington, USA), which is supplied with a dental broach sampling device, as a diagnostic alternative which could be used in field settings. Methodology/Principal findings: We evaluated the diagnostic accuracy of the CL Detect Rapid Test on skin slit and dental broach samples from suspected CL patients at the Leishmaniasis Research and Treatment Center in Gondar, Ethiopia. A combined reference test of microscopy and PCR on the skin slit sample was used, which was considered positive if one of the two tests was positive. We recruited 165 patients consecutively, of which 128 (77.6%) were confirmed as CL. All microscopy-positive results (n = 71) were also PCR-positive, and 57 patients were only positive for PCR. Sensitivity of the CL Detect Rapid Test on the skin slit was 31.3% (95% confidence interval (CI) 23.9–39.7), which was significantly higher (p = 0.010) than for the dental broach (22.7%, 95% CI 16.3–30.6). Sensitivity for both methods was significantly lower than for the routinely used microscopy, which had a sensitivity of 55.5% (IQR 46.8–63.8) compared to PCR as a reference. Conclusions/Significance: The diagnostic accuracy of the CL Detect Rapid Test was low for skin slit and dental broach samples. Therefore, we do not recommend its use neither in hospital nor field settings. Trial registration: This study is registered at ClinicalTrials.gov as NCT03837431. Author summary: Cutaneous leishmaniasis (CL) is common in Ethiopia, and mainly affects rural areas with poor access to health care. CL is routinely diagnosed using microscopy on a skin slit sample, which requires skilled staff and appropriately equipped laboratories. We evaluated the diagnostic accuracy of the CL Detect Rapid Test as an alternative which could be used in field settings. In a population of 165 patients suspected to have CL, 78% was confirmed to have CL by PCR. We found that the CL Detect Rapid Test on the supplied dental broach had a sensitivity of only 23%; on a skin slit sample, the Rapid Test had a slightly higher sensitivity with 31%. The routine diagnostic test of microscopy on the skin slit had a significantly higher sensitivity with 56%. These findings show that the sensitivity of the CL Detect Rapid Test is low, and is much worse than that of the currently used diagnostic method. Therefore, we do not recommend it to be used for diagnosing CL in Ethiopia. [ABSTRACT FROM AUTHOR]