Title:	Validation and reliability of the rapid diagnostic test ‘SD Bioeasy Dengue Duo’ for dengue diagnosis in Brazil : a phase III study
Authors:	Prado, Paulo Sousa Almeida Júnior, José Teófilo Duarte Abreu, Lanna Takada de Silva, Cristina Gabriel Souza, Larissa da Costa Gomes, Marizoneide Cavalcante Mendes, Lucinda Malheiros Teixeira Santos, Eliane Maria dos Romero, Gustavo Adolfo Sierra
Assunto::	Dengue Dengue - diagnóstico Teste rápido imunocromatográfico
Issue Date:	2018
Publisher:	Instituto Oswaldo Cruz, Ministério da Saúde
Citation:	PRADO, 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.
Abstract:	BACKGROUND 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.
metadata.dc.description.unidade:	Faculdade de Medicina (FMD)
DOI:	https://dx.doi.org/10.1590/0074-02760170433
Appears in Collections:	Artigos publicados em periódicos e afins

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