JCM Accepts, published online ahead of print on 24 June 2009

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J. Clin. Microbiol. doi:10.1128/JCM.00259-09
Copyright (c) 2009, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

The Leishmania OligoC-TesT as a simple, rapid and standardized tool for the molecular diagnosis of cutaneous leishmaniasis in Peru

Diego Espinosa^*, Andrea K. Boggild, Stijn Deborggraeve, Thierry Laurent, Cristian Valencia, Rosa Pacheco, César Miranda-Verástegui, Alejandro Llanos-Cuentas, Thierry Leclipteux, Jean-Claude Dujardin, Philippe Büscher, and Jorge Arévalo

Instituto de Medicina Tropical "Alexander von Humboldt", Universidad Peruana Cayetano Heredia, Lima, Peru; Tropical Diseases Unit, Division of Infectious Diseases, University Health Network-Toronto General Hospital, Toronto, Canada; Department of Parasitology, Institute of Tropical Medicine, Antwerp, Belgium; Coris BioConcept, Gembloux, Belgium; Universidad Nacional San Antonio Abad del Cusco, Cusco, Peru; Departamento de Bioquimica, Biologia Molecular y Farmacologia, Facultad de Ciencias, Universidad Peruana Cayetano Heredia

^* To whom correspondence should be addressed. Email: diegoespinosa{at}gmail.com.

Molecular methods such as PCR have become attractive tools for the diagnosis of cutaneous leishmaniasis (CL), both for their high sensitivity and specificity. However, the practical use in routine diagnosis is limited due to the infrastructural requirements and the lack of any standardization. Recently, a simplified and standardized PCR format for molecular detection of Leishmania was developed. The Leishmania OligoC-TesT is based on simple and rapid detection on dipstick of PCR amplified Leishmania DNA. In this study, we estimated the diagnostic accuracy of the Leishmania OligoC-TesT on 61 specimen from 44 CL suspected cases presenting at the leishmaniasis clinic of the Instituto de Medicina Tropical "Alexander von Humboldt", Peru. On the basis of parasitological detection and leishmanin skin test (LST), patients were classified as (i) confirmed CL, (ii) LST positive cases and (iii) LST negative cases. The sensitivity of the Leishmania OligoC-TesT was 74% (95% CI: 60.5%-84.1%) on lesion aspirates and 92% (95% CI: 81.2%-96.9%) on scrapings. A significant higher sensitivity was observed with a conventional PCR targeting the kinetoplast DNA (kDNA) on the aspirates (94%) (p = 0.001), while there was no significant difference in sensitivity on the lesion scrapings (88%) (p = 0.317). In addition, the Leishmania OligoC-TesT was evaluated on 13 CL suspected cases in 2 different peripheral health centers in the central jungle of Peru. Our findings clearly indicate the high accuracy of the Leishmania OligoC-TesT on lesion scrapings for simple and rapid molecular diagnosis of CL in Peru.