Universidad Peruana Cayetano Heredia

Evaluation of a diagnostic device, CL Detect rapid test for the diagnosis of new world cutaneous leishmaniasis in Peru

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dc.contributor.author Grogl, Max
dc.contributor.author Joya, Christie A.
dc.contributor.author Saenz, Maria
dc.contributor.author Quispe, Ana
dc.contributor.author Rosales, Luis Angel
dc.contributor.author del Pilar Santos, Rocio
dc.contributor.author De los Santos, Maxy B.
dc.contributor.author Donovan, Ngami
dc.contributor.author Ransom, Janet H.
dc.contributor.author Ramos Ttito, Ana Pilar
dc.contributor.author Llanos Cuentas, Elmer Alejandro
dc.coverage.spatial Universidad Peruana Cayetano Heredia, Lima, Perú
dc.coverage.spatial Jorge Chávez, Tambopata, Madre de Dios, Perú
dc.coverage.spatial Iberia, Madre de Dios, Perú
dc.coverage.spatial Santa Rosa, Madre de Dios, Perú
dc.date.accessioned 2023-04-16T04:38:13Z
dc.date.available 2023-04-16T04:38:13Z
dc.date.issued 2023
dc.identifier.uri https://hdl.handle.net/20.500.12866/13371
dc.description.abstract Background Cutaneous leishmaniasis (CL) is a neglected disease and a public health problem in Latin America. The diagnosis of CL in poor hyperendemic regions relies to large extent on the identification of amastigotes in Giemsa-stained smears. There is an urgent need for a rapid, sensitive and low cost diagnostic method for use in field conditions for CL as current modali-ties are not readily available. The primary objective of this study was to determine the sensitivity and specificity of the FDA-cleared CL Detect Rapid Test in Peru, using modified test procedures rather than the instructions-for-use, by 1) increasing the extraction time and 2) increasing the volume of the sample added to the test strip. CL Detect Rapid Test results were compared against microscopy and kDNA-PCR, for the diagnosis of CL in ulcerated lesions. In addition, we compared two collection methods the dental broach used and men-tioned in the CL Detect insert and the standard less invasive and easier to conduct scrap-ping method. Methodology Participants were patients who presented for medical consultation due to a suspected CL lesion. Four samples from the index lesion were collected using a dental broach, per package insert, and lancet scraping and tested by the modified CL Detect Rapid Test, micros-copy, and PCR. Principal findings A total of 156 subjects were eligible and evaluated. The modified CL Detect sensitivity was higher in specimens obtained by scraping (83.3%) than those from dental broach (64.2%). The specificity was lower in scrapings (77.8%) with a false positive rate of 22.2% compared with dental broach samples (91.7%) with a false positive rate of 8.3%. However, molecular analysis showed that all 8 false negative microscopy scrapings (those positive by modified CL Detect and negative by microscopy) were positive by kDNA-PCR, meaning that the modified CL Detect was more sensitive than microscopy. Conclusions These modifications to the package insert that resulted in a diagnostic sensitivity (83.3%) comparable to microscopy for species found in Peru may enable earlier anti-leishmanial drug treatment decisions based on a positive result from the CL Detect Rapid Test alone until further diagnostic tests like microscopy and PCR can be performed. Trial registration NCT03762070; Clinicaltrials.gov. © 2023, Public Library of Science. All rights reserved. en_US
dc.language.iso eng
dc.publisher Public Library of Science
dc.relation.ispartofseries PLoS Neglected Tropical Diseases
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject Specimen scraping en_US
dc.subject Leishmania en_US
dc.subject Amastigotes en_US
dc.subject Lesions en_US
dc.subject Leishmaniasis en_US
dc.subject Diagnostic medicine en_US
dc.subject Peru en_US
dc.subject Polymerase chain reaction en_US
dc.title Evaluation of a diagnostic device, CL Detect rapid test for the diagnosis of new world cutaneous leishmaniasis in Peru en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1371/journal.pntd.0011054
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.03.06
dc.relation.issn 1935-2735


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