Please use this identifier to cite or link to this item: https://www.arca.fiocruz.br/handle/icict/7494
Title: Accuracy of a dual path platform (DPP) assay for the rapid point-of-care diagnosis of human leptospirosis.
Authors: Nabity, Scott A.
Ribeiro, Guilherme de Sousa
Aquino, Carolina Lessa
Takahashi, Daniele
Damião, Alcinéia Oliveira
Gonçalves, André Henrique Oliveira
Miranda Filho, Demócrito B
Greenwald, Rena
Esfandiari, Javan
Lyashchenko, Konstantin P.
Reis, Mitermayer Galvão dos
Medeiros, Marco Alberto
Ko, Albert Icksang
Affilliation: Duke University School of Medicine. Durham, North Carolina, USA / Fundação Oswaldo Cruz. Centro de Pesquisa Gonçalo Moniz. Salvador, BA, Brasil
Fundação Oswaldo Cruz. Centro de Pesquisa Gonçalo Moniz. Salvador, BA, Brasil / Universidade Federal da Bahia. Instituto de Saúde Coletiva. Salvador, BA, Brasil
Fundação Oswaldo Cruz. Bio-Manguinhos. Rio de Janeiro, RJ, Brasil
Fundação Oswaldo Cruz. Centro de Pesquisa Gonçalo Moniz. Salvador, BA, Brasil
Fundação Oswaldo Cruz. Centro de Pesquisa Gonçalo Moniz. Salvador, BA, Brasil
Fundação Oswaldo Cruz. Centro de Pesquisa Gonçalo Moniz. Salvador, BA, Brasil
Universidade de Pernambuco. Departamento de Medicina Clínica. Recife, PE, Brasil
Chembio Diagnostic Systems. Medford, New York, USA
Chembio Diagnostic Systems. Medford, New York, USA
Chembio Diagnostic Systems. Medford, New York, USA
Fundação Oswaldo Cruz. Centro de Pesquisa Gonçalo Moniz. Salvador, BA, Brasil
Fundação Oswaldo Cruz. Bio-Manguinhos. Rio de Janeiro, RJ, Brasil
Fundação Oswaldo Cruz. Centro de Pesquisa Gonçalo Moniz. Salvador, BA, Brasil / Yale University Schools of Public Health and Medicine. New Haven, Connecticut, USA
Abstract: BACKGROUND: Diagnosis of leptospirosis by the gold standard serologic assay, the microscopic agglutination test (MAT), requires paired sera and is not widely available. We developed a rapid assay using immunodominant Leptospira immunoglobulin-like (Lig) proteins in a Dual Path Platform (DPP). This study aimed to evaluate the assay's diagnostic performance in the setting of urban transmission. METHODOLOGY: We determined test sensitivity using 446 acute and convalescent sera from MAT-confirmed case-patients with severe or mild leptospirosis in Brazil. We assessed test specificity using 677 sera from the following groups: healthy residents of a Brazilian slum with endemic transmission, febrile outpatients from the same slum, healthy blood donors, and patients with dengue, hepatitis A, and syphilis. Three operators independently interpreted visual results without knowing specimen status. RESULTS: The overall sensitivity for paired sera was 100% and 73% for severe and mild disease, respectively. In the acute phase, the assay achieved a sensitivity of 85% and 64% for severe and mild leptospirosis, respectively. Within seven days of illness onset, the assay achieved a sensitivity of 77% for severe disease and 60% for mild leptospirosis. Sensitivity of the DPP assay was similar to that for IgM-ELISA and increased with both duration of symptoms (chi-square regression P = 0.002) and agglutinating titer (Spearman Ï â€Š= 0.24, P<0.001). Specificity was ≥93% for dengue, hepatitis A, syphilis, febrile outpatients, and blood donors, while it was 86% for healthy slum residents. Inter-operator agreement ranged from very good to excellent (kappa: 0.82-0.94) and test-to-test reproducibility was also high (kappa: 0.89). CONCLUSIONS: The DPP assay performed acceptably well for diagnosis of severe acute clinical leptospirosis and can be easily implemented in hospitals and health posts where leptospirosis is a major public health problem. However, test accuracy may need improvement for mild disease
DeCS: Técnicas de Laboratório Clínico/métodos
Leptospira/imunologia
Leptospirose/diagnóstico
Sistemas Automatizados de Assistência Junto ao Leito
Adolescente
Adulto
Brasil
Criança
Feminino
Humanos
Imunoensaio/métodos
Masculino
Meia-Idade
Sensibilidade e Especificidade
Adulto Jovem
Issue Date: 2012
Publisher: Public Library of Science
Citation: NABITY, S. A. et al. Accuracy of a dual path platform (DPP) assay for the rapid point-f-care diagnosis of human leptospirosis. PLoS Neglected Tropical Diseases, v. 6, n. 11, p. e1878, 2012.
DOI: 10.1371/journal.pntd.0001878
ISSN: 1935-2735
Copyright: open access
Appears in Collections:BA - IGM - Artigos de Periódicos

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