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Journal of Clinical Microbiology, August 2009, p. 2560-2563, Vol. 47, No. 8
0095-1137/09/$08.00+0     doi:10.1128/JCM.00259-09
Copyright © 2009, American Society for Microbiology. All Rights Reserved.

Leishmania OligoC-TesT as a Simple, Rapid, and Standardized Tool for Molecular Diagnosis of Cutaneous Leishmaniasis in Peru{triangledown}

Diego Espinosa,1* Andrea K. Boggild,2 Stijn Deborggraeve,3 Thierry Laurent,4 Cristian Valencia,1 Rosa Pacheco,5 César Miranda-Verástegui,1 Alejandro Llanos-Cuentas,1 Thierry Leclipteux,4 Jean-Claude Dujardin,3 Philippe Büscher,3 and Jorge Arévalo1,6

Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru,1 Tropical Diseases Unit, Division of Infectious Diseases, University Health Network, Toronto General Hospital, Toronto, Canada,2 Department of Parasitology, Institute of Tropical Medicine, Antwerp, Belgium,3 Coris BioConcept, Gembloux, Belgium,4 Universidad Nacional San Antonio Abad del Cusco, Cusco, Peru,5 Departamento de Bioquimica, Biologia Molecular y Farmacologia, Facultad de Ciencias, Universidad Peruana Cayetano Heredia, Lima, Peru6

Received 6 February 2009/ Returned for modification 20 May 2009/ Accepted 16 June 2009

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

* Corresponding author. Mailing address: Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Avenida Honorio Delgado 430, Lima 31, Peru. Phone: (51-1) 482-3910. Fax: (51-1) 482-3404. E-mail: diegoespinosa{at}gmail.com

{triangledown} Published ahead of print on 24 June 2009.

Journal of Clinical Microbiology, August 2009, p. 2560-2563, Vol. 47, No. 8
0095-1137/09/$08.00+0     doi:10.1128/JCM.00259-09
Copyright © 2009, American Society for Microbiology. All Rights Reserved.





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