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3100-12-31
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ACCURACY OF SEROLOGICAL TESTS IN DIAGNOSING MUCOSAL LEISHMANIASIS.
Leishmania braziliensis
Mucosal leishmaniasis
Sensitivity
Serology
Specificity
Autor
Afiliación
Clinical Research and Public Politics in Infectious and Parasitic Diseases. René Rachou Institute. Oswaldo Cruz Foundation. Belo Horizonte, MG, Brazil
Clinical Research and Public Politics in Infectious and Parasitic Diseases. René Rachou Institute. Oswaldo Cruz Foundation. Belo Horizonte, MG, Brazil
Clinical Research and Public Politics in Infectious and Parasitic Diseases. René Rachou Institute. Oswaldo Cruz Foundation. Belo Horizonte, MG, Brazil
Clinical Research and Public Politics in Infectious and Parasitic Diseases. René Rachou Institute. Oswaldo Cruz Foundation. Belo Horizonte, MG, Brazil
Clinical Research and Public Politics in Infectious and Parasitic Diseases. René Rachou Institute. Oswaldo Cruz Foundation. Belo Horizonte, MG, Brazil
Clinical Research and Public Politics in Infectious and Parasitic Diseases. René Rachou Institute. Oswaldo Cruz Foundation. Belo Horizonte, MG, Brazil
Clinical Research and Public Politics in Infectious and Parasitic Diseases. René Rachou Institute. Oswaldo Cruz Foundation. Belo Horizonte, MG, Brazil
Clinical Research and Public Politics in Infectious and Parasitic Diseases. René Rachou Institute. Oswaldo Cruz Foundation. Belo Horizonte, MG, Brazil
Clinical Research and Public Politics in Infectious and Parasitic Diseases. René Rachou Institute. Oswaldo Cruz Foundation. Belo Horizonte, MG, Brazil
Resumen en ingles
In this serum panel-based study, we evaluated the accuracy of serological tests originally developed for visceral leishmaniasis (VL), for diagnosis of mucosal leishmaniasis (ML). A total of five tests were evaluated, four of which are registered at the National Agency of Sanitary Surveillance (Agência Nacional de Vigilância Sanitária-ANVISA) (RIDASCREEN® Leishmania Ab from R-Biopharm AG., Leishmania ELISA IgG + IgM from Vircell S.L., IFI Leishmaniose Humana-BioManguinhos, and IT-LEISH® from Bio-Rad Laboratories, Inc.), and the other a direct agglutination test (DAT-LPC) prototype kit developed at Fiocruz. The panel was composed of 40 serum samples from patients with confirmed ML and 20 from patients with mucosal involvement and negative parasitological/molecular tests for leishmaniasis and confirmation of another etiology. All cases were treated from 2009 to 2016 in a referral center for leishmaniasis in Belo Horizonte, Minas Gerais, Brazil (Instituto René Rachou, Fiocruz). Diagnostic accuracy, based on the cut-off point for VL diagnosis, was 86.2% with RIDASCREEN® Leishmania Ab, 73.3% with Leishmania ELISA IgG + IgM, and 66.7% with IFI Leishmaniose Humana, while IT-LEISH® and DAT-LPC had the lowest accuracy (38.3%), despite high specificity (100% and 95%, respectively). New cut-off points defined with sera from ML patients improved accuracy from 86.2 to 89% (p = 0.64) and 73.3 to 88% (p = 0.04) for RIDASCREEN® Leishmania Ab and Leishmania ELISA IgG + IgM, respectively. Moreover, these tests presented greater sensitivity and immunoreactivity in patients with moderate/severe clinical ML forms. The data of this study suggest that ELISA assays can contribute to laboratory diagnosis, especially for patients with moderate or severe mucosal involvement.
Palabras clave en ingles
AccuracyLeishmania braziliensis
Mucosal leishmaniasis
Sensitivity
Serology
Specificity
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