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dc.contributor.authorPrado, Paulo Sousapt_BR
dc.contributor.authorAlmeida Júnior, José Teófilo Duartept_BR
dc.contributor.authorAbreu, Lanna Takada dept_BR
dc.contributor.authorSilva, Cristina Gabrielpt_BR
dc.contributor.authorSouza, Larissa da Costapt_BR
dc.contributor.authorGomes, Marizoneide Cavalcantept_BR
dc.contributor.authorMendes, Lucinda Malheiros Teixeirapt_BR
dc.contributor.authorSantos, Eliane Maria dospt_BR
dc.contributor.authorRomero, Gustavo Adolfo Sierrapt_BR
dc.date.accessioned2019-01-02T13:50:29Z-
dc.date.available2019-01-02T13:50:29Z-
dc.date.issued2018pt_BR
dc.identifier.citationPRADO, Paulo Sousa et al. Validation and reliability of the rapid diagnostic test ‘SD Bioeasy Dengue Duo’ for dengue diagnosis in Brazil: a phase III study. Memórias do Instituto Oswaldo Cruz, Rio de Janeiro, v. 113, n. 8, e170433, 2018. DOI: http://dx.doi.org/10.1590/0074-02760170433. Disponível em: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0074-02762018000800302&lng=en&nrm=iso. Acesso em: 10 jun. 2019. Epub June 25, 2018.pt_BR
dc.identifier.urihttp://repositorio.unb.br/handle/10482/33326-
dc.language.isoenpt_BR
dc.publisherInstituto Oswaldo Cruz, Ministério da Saúdept_BR
dc.rightsAcesso Abertopt_BR
dc.titleValidation and reliability of the rapid diagnostic test ‘SD Bioeasy Dengue Duo’ for dengue diagnosis in Brazil : a phase III studypt_BR
dc.typeArtigopt_BR
dc.subject.keywordDenguept_BR
dc.subject.keywordDengue - diagnósticopt_BR
dc.subject.keywordTeste rápido imunocromatográficopt_BR
dc.identifier.doihttps://dx.doi.org/10.1590/0074-02760170433pt_BR
dc.description.abstract1BACKGROUND The diagnosis of dengue is complex. Until recently, only specialised laboratories were able to confirm dengue infection. However, this has changed with the newly available immunochromatographic rapid tests. Early diagnosis is of great interest, and point-of-care rapid tests have been increasingly used in Brazil. Most of those tests have not undergone validation in the Brazilian population. In this context, we decided to evaluate a rapid test introduced in the Federal District (FD). OBJECTIVES To estimate the accuracy and reliability of the SD Bioeasy Dengue Duo rapid test and its components to detect dengue infections in a consecutive sample of symptomatic residents in the FD, Brazil. METHODS In total, 1353 venous blood samples were collected between 2013 and 2014. Two hundred and six positive samples (cases) and 246 negative samples (non cases) were required for sensitivity and specificity estimation, respectively; for agreement evaluation, we used 401 samples. The reference standard used was a composite of MAC-ELISA, virus isolation and real-time polymerase chain reaction (RT-qPCR). The evaluation was conducted prospectively under field conditions in the public health units of the FD. FINDINGS The results for the overall accuracy of the rapid test (NS1/IgM combined) showed 76% sensitivity and 98% specificity. The sensitivity for the NS1 component (67%) was better than that for the IgM component (35%). The positive likelihood ratio was 46, and the negative likelihood ratio was 0.24. The reliability of the test (NS1/IgM combined) demonstrated crude agreement of 98% (Kappa index 0.94). MAIN CONCLUSIONS The present phase III, large-scale validation study demonstrates that the rapid test SD Bioeasy Dengue Duo has moderate sensitivity (NS1/IgM combined) and high specificity. Therefore, the test is useful in confirming the diagnosis of dengue, but not enough to rule out the diagnosis. Our results also suggest that Dengue virus (DENV) viral load estimated through the RT-qPCR and antibody level measured through the MAC-ELISA could have had a direct influence on the accuracy of the rapid test.-
dc.description.unidadeFaculdade de Medicina (FMD)-
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