Abstract
BackgroundCutaneous 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 findingsWe 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/SignificanceThe 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 registrationThis study is registered at ClinicalTrials.gov as NCT03837431.
Highlights
Cutaneous leishmaniasis (CL) is a skin infection caused by intracellular protozoa that are transmitted by sand flies
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
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
Summary
Cutaneous leishmaniasis (CL) is a skin infection caused by intracellular protozoa that are transmitted by sand flies. It is endemic in many countries worldwide with an estimated yearly global incidence between 690,000 and 1,200,000 cases [1]. In Ethiopia, L. aethiopica is the main species causing CL, with Phlebotomus pedifer and Phlebotomus longipes acting as vectors, and hyraxes as their reservoir [2]. The estimated yearly incidence of CL in Ethiopia is between 20,000 and 50,000 cases [1], with children as an important patient group [4]. Cutaneous leishmaniasis (CL) is common in Ethiopia, mainly affecting impoverished populations in rural areas with poor access to health care. 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.
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