Accuracy of the SD BIOLINE Dengue Duo for rapid point-of-care diagnosis of dengue.

Autor: Kikuti M; Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, Bahia, Brazil.; Instituto de Saúde Coletiva, Universidade Federal da Bahia, Salvador, Bahia, Brazil., Cruz JS; Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, Bahia, Brazil., Rodrigues MS; Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, Bahia, Brazil., Tavares AS; Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, Bahia, Brazil., Paploski IAD; Instituto de Saúde Coletiva, Universidade Federal da Bahia, Salvador, Bahia, Brazil.; Department of Veterinary Population Medicine, University of Minnesota, Saint Paul, Minnesota, United States of America., Silva MMO; Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, Bahia, Brazil., Santana PM; Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, Bahia, Brazil., Tauro LB; Instituto Nacional de Medicina Tropical, CONICET, Puerto Iguazu, Misiones, Argentina., Silva GAOF; Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, Bahia, Brazil., Campos GS; Instituto de Ciências da Saúde, Universidade Federal da Bahia, Salvador, Bahia, Brazil., Araújo JMG; Departamento de Microbiologia e Parasitologia, Universidade Federal do Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil., Kitron U; Department of Environmental Science, Emory University, Atlanta, Georgia, United States of America., Reis MG; Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, Bahia, Brazil.; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, Connecticut, United States of America.; Faculdade de Medicina da Bahia, Universidade Federal da Bahia, Salvador, Bahia, Brazil., Ribeiro GS; Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, Bahia, Brazil.; Instituto de Saúde Coletiva, Universidade Federal da Bahia, Salvador, Bahia, Brazil.; Faculdade de Medicina da Bahia, Universidade Federal da Bahia, Salvador, Bahia, Brazil.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2019 Mar 06; Vol. 14 (3), pp. e0213301. Date of Electronic Publication: 2019 Mar 06 (Print Publication: 2019).
DOI: 10.1371/journal.pone.0213301
Abstrakt: Background: Rapid diagnosis tests (RDTs) are easy to carry out, provide fast results, and could potentially guide medical treatment decisions. We investigated the performance of a commercially available RDT, which simultaneously detects the non-structural 1 (NS1) dengue virus (DENV) antigen, and IgM and IgG DENV antibodies, using representative serum samples from individuals in a dengue endemic area in Salvador, Brazil.
Methodology/principal Findings: We evaluated the accuracy of the SD BIOLINE Dengue Duo RDT (Abbott, Santa Clara, USA; former Alere Inc, Waltham, USA) in a random collection of sera. Samples included acute-phase sera from 246 laboratory-confirmed dengue cases and 108 non-dengue febrile patients enrolled in a surveillance study for dengue detection, 73 healthy controls living in the same surveillance community, and 73 blood donors. RDT accuracy was blindly assessed based on the combined results for the NS1 and the IgM test components. The RDT sensitivity was 46.8% (38.6% for the NS1 component and 13.8% for the IgM component). Sensitivity was greater for samples obtained from patients with secondary DENV infections (49.8%) compared to primary infections (31.1%) (P: 0.02) and was also influenced by the result in the confirmatory dengue diagnostic test, ranging from 39.7% for samples of cases confirmed by IgM-ELISA seroconversion between paired samples to 90.4% for samples of cases confirmed by a positive NS1-ELISA. The RDT specificity was 94.4% for non-dengue febrile patients, 87.7% for the community healthy controls, and 95.9% for the blood donors.
Conclusions/significance: The SD BIOLINE Dengue Duo RDT showed good specificities, but low sensitivity, suggesting that it may be more useful to rule in than to rule out a dengue diagnosis in dengue endemic regions.
Competing Interests: The authors have declared that no competing interests exist.
Databáze: MEDLINE
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