Clinical and Demographic Stratification of Test Performance: A Pooled Analysis of Five Laboratory Diagnostic Methods for American Cutaneous Leishmaniasis

Andrea K. Boggild Tropical Disease Unit, Division of Infectious Diseases, University Health Network–Toronto General Hospital, Toronto, Ontario, Canada; Instituto de Medicina Tropical Alexander von Humboldt, y Departamento de Bioquimica, Biologia Molecular y Farmacologia, Facultad de Ciencias, Universidad Peruana Cayetano Heredia, Lima, Peru; Laboratories Branch, Ontario Agency for Health Protection and Promotion, Etobicoke, Ontario, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada; Hospital Nacional Cayetano Heredia, Lima, Peru

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Ana P. Ramos Tropical Disease Unit, Division of Infectious Diseases, University Health Network–Toronto General Hospital, Toronto, Ontario, Canada; Instituto de Medicina Tropical Alexander von Humboldt, y Departamento de Bioquimica, Biologia Molecular y Farmacologia, Facultad de Ciencias, Universidad Peruana Cayetano Heredia, Lima, Peru; Laboratories Branch, Ontario Agency for Health Protection and Promotion, Etobicoke, Ontario, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada; Hospital Nacional Cayetano Heredia, Lima, Peru

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Diego Espinosa Tropical Disease Unit, Division of Infectious Diseases, University Health Network–Toronto General Hospital, Toronto, Ontario, Canada; Instituto de Medicina Tropical Alexander von Humboldt, y Departamento de Bioquimica, Biologia Molecular y Farmacologia, Facultad de Ciencias, Universidad Peruana Cayetano Heredia, Lima, Peru; Laboratories Branch, Ontario Agency for Health Protection and Promotion, Etobicoke, Ontario, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada; Hospital Nacional Cayetano Heredia, Lima, Peru

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Braulio M. Valencia Tropical Disease Unit, Division of Infectious Diseases, University Health Network–Toronto General Hospital, Toronto, Ontario, Canada; Instituto de Medicina Tropical Alexander von Humboldt, y Departamento de Bioquimica, Biologia Molecular y Farmacologia, Facultad de Ciencias, Universidad Peruana Cayetano Heredia, Lima, Peru; Laboratories Branch, Ontario Agency for Health Protection and Promotion, Etobicoke, Ontario, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada; Hospital Nacional Cayetano Heredia, Lima, Peru

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Nicolas Veland Tropical Disease Unit, Division of Infectious Diseases, University Health Network–Toronto General Hospital, Toronto, Ontario, Canada; Instituto de Medicina Tropical Alexander von Humboldt, y Departamento de Bioquimica, Biologia Molecular y Farmacologia, Facultad de Ciencias, Universidad Peruana Cayetano Heredia, Lima, Peru; Laboratories Branch, Ontario Agency for Health Protection and Promotion, Etobicoke, Ontario, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada; Hospital Nacional Cayetano Heredia, Lima, Peru

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Cesar Miranda-Verastegui Tropical Disease Unit, Division of Infectious Diseases, University Health Network–Toronto General Hospital, Toronto, Ontario, Canada; Instituto de Medicina Tropical Alexander von Humboldt, y Departamento de Bioquimica, Biologia Molecular y Farmacologia, Facultad de Ciencias, Universidad Peruana Cayetano Heredia, Lima, Peru; Laboratories Branch, Ontario Agency for Health Protection and Promotion, Etobicoke, Ontario, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada; Hospital Nacional Cayetano Heredia, Lima, Peru

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Jorge Arevalo Tropical Disease Unit, Division of Infectious Diseases, University Health Network–Toronto General Hospital, Toronto, Ontario, Canada; Instituto de Medicina Tropical Alexander von Humboldt, y Departamento de Bioquimica, Biologia Molecular y Farmacologia, Facultad de Ciencias, Universidad Peruana Cayetano Heredia, Lima, Peru; Laboratories Branch, Ontario Agency for Health Protection and Promotion, Etobicoke, Ontario, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada; Hospital Nacional Cayetano Heredia, Lima, Peru

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Donald E. Low Tropical Disease Unit, Division of Infectious Diseases, University Health Network–Toronto General Hospital, Toronto, Ontario, Canada; Instituto de Medicina Tropical Alexander von Humboldt, y Departamento de Bioquimica, Biologia Molecular y Farmacologia, Facultad de Ciencias, Universidad Peruana Cayetano Heredia, Lima, Peru; Laboratories Branch, Ontario Agency for Health Protection and Promotion, Etobicoke, Ontario, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada; Hospital Nacional Cayetano Heredia, Lima, Peru

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Alejandro Llanos-Cuentas Tropical Disease Unit, Division of Infectious Diseases, University Health Network–Toronto General Hospital, Toronto, Ontario, Canada; Instituto de Medicina Tropical Alexander von Humboldt, y Departamento de Bioquimica, Biologia Molecular y Farmacologia, Facultad de Ciencias, Universidad Peruana Cayetano Heredia, Lima, Peru; Laboratories Branch, Ontario Agency for Health Protection and Promotion, Etobicoke, Ontario, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada; Hospital Nacional Cayetano Heredia, Lima, Peru

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We evaluated performance characteristics of five diagnostic methods for cutaneous leishmaniasis. Patients who came to the Leishmania Clinic of Hospital Nacional Cayetano Heredia in Lima, Peru, were enrolled in the study. Lesion smears, culture, microculture, polymerase chain reaction (PCR), and leishmanin skin test (LST) were performed. A total of 145 patients with 202 lesions were enrolled: 114 patients with 161 lesions fulfilled criteria for cutaneous leishmaniasis. Sensitivity and specificity were 57.8% (95% confidence interval [CI] = 50.2–65.4%) and 100.0% for culture, 78.3% (95% CI = 71.9–84.7%) and 100.0% for microculture, 71.4% (95% CI = 64.4–78.4%) and 100.0% for smears, 78.2% (95% CI = 70.6–85.8%) and 77.4% (95% CI = 62.7–92.1%) for LST, and 96.9% (95% CI = 94.2–99.6%) and 65.9% (95% CI = 51.4–80.4%) for PCR. PCR was more sensitive than the other assays (P < 0.001). Sensitivities of culture, smears, and LST varied by lesion duration and appearance. PCR offers performance advantages over other assays, irrespective of patient age, sex, lesion duration, or appearance. That clinical factors influence performance of non-molecular assays offers clinicians a patient-focused approach to diagnostic test selection.

Author Notes

*Address correspondence to Andrea K. Boggild, Tropical Disease Unit, University Health Network–Toronto General Hospital, 200 Elizabeth Street, North Wing, 13th Floor, Room 1350, Toronto, Ontario M5G 2C4, Canada. E-mail: andrea.boggild@utoronto.ca

Financial support: This study was partially supported by a Small Research Grant through the Ontario Association of Medical Laboratories (2007 enrollment period). Andrea K. Boggild was supported by a professional development grant through the Royal College of Physicians and Surgeons of Canada during one of the study periods (2009).

Authors' addresses: Andrea K. Boggild, Tropical Disease Unit, University Health Network–Toronto General Hospital, Toronto, Ontario, Canada, E-mail: andrea.boggild@utoronto.ca. Ana P. Ramos, Diego Espinosa, Braulio M. Valencia, Nicolas Veland, Cesar Miranda-Versategui, and Alejandro Llanos-Cuentas, Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, URB Ingenieria, Lima, Peru, E-mails: anapilarupch@hotmail.com, diegoespinosa@gmail.com, 18406@upch.edu.pe, nicolasveland@yahoo.com, cesar.miranda@mail.mcgill.ca, and allanos@upch.edu.pe. Jorge Arevalo, Departmento de Bioquimica, Biologia Molecular y Farmacologia, Facultad de Ciencias, Universidad Peruana Cayetano Heredia, URB Ingenieria, Lima, Peru, E-mail: biomoljazz@gmail.com. Donald E. Low, Department of Microbiology, Mount Sinai Hospital, Toronto, Ontario, Canada and Laboratories Branch, Ontario Agency for Health Protection and Promotion, Etobicoke, Ontario, Canada, E-mail: don.low@oahpp.ca.

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