title: Leishmania OligoC-TesT as a simple, rapid, and standardized tool for molecular diagnosis of cutaneous leishmaniasis in Peru.
abstract: 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.
authors: Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru. diegoespinosa@gmail.com
authors: Diego
authors: D
authors: Espinosa
authors: Andrea K
authors: AK
authors: Boggild
authors: Stijn
authors: S
authors: Deborggraeve
authors: Thierry
authors: T
authors: Laurent
authors: Cristian
authors: C
authors: Valencia
authors: Rosa
authors: R
authors: Pacheco
authors: César
authors: C
authors: Miranda-Verástegui
authors: Alejandro
authors: A
authors: Llanos-Cuentas
authors: Thierry
authors: T
authors: Leclipteux
authors: Jean-Claude
authors: JC
authors: Dujardin
authors: Philippe
authors: P
authors: Büscher
authors: Jorge
authors: J
authors: Arévalo
mesh_terms: D000818:Animals; D006801:Humans; D007891:Leishmania / Q000235:genetics / Q000302:isolation & purification*; D016773:Leishmaniasis, Cutaneous / Q000175:diagnosis* / Q000469:parasitology; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D010568:Peru; D016133:Polymerase Chain Reaction / Q000379:methods*; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D012867:Skin / Q000469:parasitology
chemical_list: D011933:Reagent Kits, Diagnostic