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Am. J. Trop. Med. Hyg., 82(2), 2010, pp. 251-256
doi:10.4269/ajtmh.2010.09-0366;
Copyright © 2010 by The American Society of Tropical Medicine and Hygiene

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Leishmania Infection: Laboratory Diagnosing in the Absence of a "Gold Standard"

Alhelí Rodríguez-Cortés, Ana Ojeda, Olga Francino, Laura López-Fuertes, Marcos Timón, AND Jordi Alberola*
Unitat de Farmacologia Veterinària and LeishLAB–Servei d’Anàlisi de Fàrmacs, Departament de Farmacologia, de Terapèutica i de Toxicologia, Universitat Autònoma de Barcelona, Bellaterra (Barcelona), Spain; Servei Veterinari de Genètica Molecular, Departament de Ciència Animal i dels Aliments, Facultat de Veterinària, Universitat Autònoma de Barcelona, Bellaterra (Barcelona), Spain; Innoqua, Toxicology Consultants, Barcelona, Spain; Agencia Española del Medicamento, Madrid, Spain

There is no gold standard for diagnosing leishmaniases. Our aim was to assess the operative validity of tests used in detecting Leishmania infection using samples from experimental infections, a reliable equivalent to the classic definition of gold standard. Without statistical differences, the highest sensitivity was achieved by protein A (ProtA), immunoglobulin (Ig)G2, indirect fluorescenece antibody test (IFAT), lymphocyte proliferation assay, quantitative real-time polymerase chain reaction of bone marrow (qPCR-BM), qPCR-Blood, and IgG; and the highest specificity by IgG1, IgM, IgA, qPCR-Blood, IgG, IgG2, and qPCR-BM. Maximum positive predictive value was obtained simultaneously by IgG2, qPCR-Blood, and IgG; and maximum negative predictive value by qPCR-BM. Best positive and negative likelihood ratios were obtained by IgG2. The test having the greatest, statistically significant, area under the receiver operating characteristics curve was IgG2 enzyme-linked immunosorbent assay (ELISA). Thus, according to the gold standard used, IFAT and qPCR are far from fulfilling the requirements to be considered gold standards, and the test showing the highest potential to detect Leishmania infection is Leishmania-specific ELISA IgG2.

Received June 29, 2009. Accepted for publication October 17, 2009.

Financial Support: This work was financed in part by Projects BIO2004-03893 and AGL2008-00748, both for Jordi Alberola from the Spanish Government.

Authors' addresses: Alhelí Rodríguez-Cortés, Ana Ojeda, and Jordi Alberola, Unitat de Farmacologia Veterinària and LeishLAB–Servei d’Anàlisi de Fàrmacs, Departament de Farmacologia, de Terapèutica i de Toxicologia, Universitat Autònoma de Barcelona, Bellaterra (Barcelona), Spain, E-mails: Alheli.Rodriguez{at}uab.cat, Ana.Ojeda{at}uab.cat, and Jordi.Alberola{at}uab.cat. Olga Francino, Servei Veterinari de Genètica Molecular, Departament de Ciència Animal i dels Aliments, Facultat de Veterinària, Universitat Autònoma de Barcelona, Bellaterra (Barcelona), Spain, E-mail: Olga.Francino{at}uab.cat. Laura López-Fuertes, Innoqua, Toxicology Consultants, Barcelona, Spain, E-mail: llopezfuertes{at}gmail.com. Marcos Timón, Agencia Española del Medicamento, Madrid, Spain, E-mail: mtimon{at}agemed.es.

Reprint requests: Jordi Alberola, Unitat de Farmacologia Veterinària and LeishLAB–Servei d’Anàlisi de Fàrmacs, Departament de Farmacologia, de Terapèutica i de Toxicologia, Universitat Autònoma de Barcelona, Bellaterra (Barcelona), Spain, E-mail: Jordi.Alberola{at}uab.cat.

*Address correspondence to Jordi Alberola, Unitat de Farmacologia Veterinària and LeishLAB–Servei d’Anàlisi de Fàrmacs, Departament de Farmacologia, de Terapèutica i de Toxicologia, Universitat Autònoma de Barcelona, Bellaterra (Barcelona), Spain. E-mail: Jordi.Alberola{at}uab.cat






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