title: Diagnostic accuracy of an IgM enzyme-linked immunosorbent assay and comparison with 2 polymerase chain reactions for early diagnosis of human leptospirosis.
abstract: Enzyme-linked immunosorbent assay (ELISA) tests and polymerase chain reaction (PCR) may play a key role for early detection and treatment of human leptospirosis in developing countries. The aims of this study were to develop and validate an IgM ELISA under field conditions and to compare the diagnostic accuracy among IgG, IgM ELISAs, conventional PCR (cPCR), and real-time PCR (rtPCR) for early detection of human leptospirosis. Overall accuracy of IgM ELISA was sensitivity of 87.9%, specificity of 97.0%, and area under the curve of 0.940. When the 4 methods were compared, IgM ELISA showed the greatest diagnostic accuracy (J=0.6) followed by rtPCR (J=0.4), cPCR (J=0.2) and IgG ELISA (J=0.1). Our results support the use of IgM ELISA and rtPCR for early diagnosis of the disease. Moreover, due to their high specificity, they could be also useful to replace or supplement microscopic agglutination test as a confirmatory test, allowing more confirmations.
authors: Instituto Nacional de Enfermedades Respiratorias (INER) "Dr. Emilio Coni", Administración Nacional de Laboratorios e Institutos de Salud (ANLIS) "Dr. Carlos G. Malbrán", Av. Blas Parera 8260, 3000 Santa Fe, Argentina; Facultad de Bioquímica y Ciencias Biológicas, Universidad Nacional del Litoral (FBCB-UNL), Santa Fe, Argentina; Ciudad Universitaria, Paraje El Pozo, 3000 Santa Fe, Argentina.
authors: N B
authors: NB
authors: Vanasco
authors: Instituto Nacional de Enfermedades Respiratorias (INER) "Dr. Emilio Coni", Administración Nacional de Laboratorios e Institutos de Salud (ANLIS) "Dr. Carlos G. Malbrán", Av. Blas Parera 8260, 3000 Santa Fe, Argentina.
authors: P
authors: P
authors: Jacob
authors: Instituto Nacional de Enfermedades Respiratorias (INER) "Dr. Emilio Coni", Administración Nacional de Laboratorios e Institutos de Salud (ANLIS) "Dr. Carlos G. Malbrán", Av. Blas Parera 8260, 3000 Santa Fe, Argentina.
authors: N
authors: N
authors: Landolt
authors: Instituto Nacional de Enfermedades Respiratorias (INER) "Dr. Emilio Coni", Administración Nacional de Laboratorios e Institutos de Salud (ANLIS) "Dr. Carlos G. Malbrán", Av. Blas Parera 8260, 3000 Santa Fe, Argentina.
authors: Y
authors: Y
authors: Chiani
authors: Instituto Nacional de Enfermedades Respiratorias (INER) "Dr. Emilio Coni", Administración Nacional de Laboratorios e Institutos de Salud (ANLIS) "Dr. Carlos G. Malbrán", Av. Blas Parera 8260, 3000 Santa Fe, Argentina.
authors: M F
authors: MF
authors: Schmeling
authors: Instituto Nacional de Enfermedades Respiratorias (INER) "Dr. Emilio Coni", Administración Nacional de Laboratorios e Institutos de Salud (ANLIS) "Dr. Carlos G. Malbrán", Av. Blas Parera 8260, 3000 Santa Fe, Argentina.
authors: C
authors: C
authors: Cudos
authors: Facultad de Ciencias Veterinarias, Universidad Nacional del Litoral (FCV-UNL), Kreder 2086, 3080 Esperanza, Santa Fe, Argentina.
authors: H
authors: H
authors: Tarabla
authors: Instituto Nacional de Enfermedades Respiratorias (INER) "Dr. Emilio Coni", Administración Nacional de Laboratorios e Institutos de Salud (ANLIS) "Dr. Carlos G. Malbrán", Av. Blas Parera 8260, 3000 Santa Fe, Argentina; Facultad de Bioquímica y Ciencias Biológicas, Universidad Nacional del Litoral (FBCB-UNL), Santa Fe, Argentina; Ciudad Universitaria, Paraje El Pozo, 3000 Santa Fe, Argentina.
authors: J
authors: J
authors: Lottersberger
mesh_terms: D000328:Adult; D000368:Aged; D000907:Antibodies, Bacterial / Q000097:blood; D004269:DNA, Bacterial / Q000032:analysis*; D042241:Early Diagnosis; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D006801:Humans; D007075:Immunoglobulin M / Q000097:blood*; D007922:Leptospirosis / Q000175:diagnosis*; D008297:Male; D008875:Middle Aged; D016133:Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity
chemical_list: D000907:Antibodies, Bacterial; D004269:DNA, Bacterial; D007075:Immunoglobulin M
keywords: Diagnostic methods; Human leptospirosis; IgG ELISA; IgM ELISA; Real time PCR, conventional PCR