TY - JOUR
T1 - Evaluation of the CL detect rapid test in Ethiopian patients suspected for cutaneous leishmaniasis
AU - van Henten, Saskia
AU - Fikre, Helina
AU - Melkamu, Roma
AU - Dessie, Dilargachew
AU - Mekonnen, Tigist
AU - Kassa, Mekibib
AU - Bogale, Tadfe
AU - Mohammed, Rezika
AU - Cnops, Lieselotte
AU - Vogt, Florian
AU - Pareyn, Myrthe
AU - van Griensven, Johan
N1 - FTX; DOAJ; (CC BY 4.0)
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
U2 - 10.1371/journal.pntd.0010143
DO - 10.1371/journal.pntd.0010143
M3 - A1: Web of Science-article
C2 - 35041672
SN - 1935-2727
VL - 16
JO - PLoS Neglected Tropical Diseases
JF - PLoS Neglected Tropical Diseases
IS - 1
M1 - e0010143
ER -