Validation and reliability of the rapid diagnostic test ‘SD Bioeasy Dengue Duo’ for dengue diagnosis in Brazil: a phase III study

Detalhes bibliográficos
Autor(a) principal: Prado,Paulo Sousa
Data de Publicação: 2018
Outros Autores: 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
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Memórias do Instituto Oswaldo Cruz
Texto Completo: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0074-02762018000800302
Resumo: 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.
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spelling Validation and reliability of the rapid diagnostic test ‘SD Bioeasy Dengue Duo’ for dengue diagnosis in Brazil: a phase III studydenguedengue diagnosisimmunochromatographic rapid testsaccuracy 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.Instituto Oswaldo Cruz, Ministério da Saúde2018-01-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://www.scielo.br/scielo.php?script=sci_arttext&pid=S0074-02762018000800302Memórias do Instituto Oswaldo Cruz v.113 n.8 2018reponame:Memórias do Instituto Oswaldo Cruzinstname:Fundação Oswaldo Cruzinstacron:FIOCRUZ10.1590/0074-02760170433info:eu-repo/semantics/openAccessPrado,Paulo SousaAlmeida Júnior,José Teófilo DuarteAbreu,Lanna Takada deSilva,Cristina GabrielSouza,Larissa da CostaGomes,Marizoneide CavalcanteMendes,Lucinda Malheiros TeixeiraSantos,Eliane Maria dosRomero,Gustavo Adolfo Sierraeng2020-04-25T17:52:52Zhttp://www.scielo.br/oai/scielo-oai.php0074-02761678-8060opendoar:null2020-04-26 02:22:20.308Memórias do Instituto Oswaldo Cruz - Fundação Oswaldo Cruztrue
dc.title.none.fl_str_mv Validation and reliability of the rapid diagnostic test ‘SD Bioeasy Dengue Duo’ for dengue diagnosis in Brazil: a phase III study
title Validation and reliability of the rapid diagnostic test ‘SD Bioeasy Dengue Duo’ for dengue diagnosis in Brazil: a phase III study
spellingShingle Validation and reliability of the rapid diagnostic test ‘SD Bioeasy Dengue Duo’ for dengue diagnosis in Brazil: a phase III study
Prado,Paulo Sousa
dengue
dengue diagnosis
immunochromatographic rapid tests
accuracy
title_short Validation and reliability of the rapid diagnostic test ‘SD Bioeasy Dengue Duo’ for dengue diagnosis in Brazil: a phase III study
title_full Validation and reliability of the rapid diagnostic test ‘SD Bioeasy Dengue Duo’ for dengue diagnosis in Brazil: a phase III study
title_fullStr Validation and reliability of the rapid diagnostic test ‘SD Bioeasy Dengue Duo’ for dengue diagnosis in Brazil: a phase III study
title_full_unstemmed Validation and reliability of the rapid diagnostic test ‘SD Bioeasy Dengue Duo’ for dengue diagnosis in Brazil: a phase III study
title_sort Validation and reliability of the rapid diagnostic test ‘SD Bioeasy Dengue Duo’ for dengue diagnosis in Brazil: a phase III study
author Prado,Paulo Sousa
author_facet 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
author_role author
author2 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
author2_role author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv 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
dc.subject.por.fl_str_mv dengue
dengue diagnosis
immunochromatographic rapid tests
accuracy
topic dengue
dengue diagnosis
immunochromatographic rapid tests
accuracy
dc.description.none.fl_txt_mv 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.
description 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.
publishDate 2018
dc.date.none.fl_str_mv 2018-01-01
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0074-02762018000800302
url http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0074-02762018000800302
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 10.1590/0074-02760170433
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
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dc.publisher.none.fl_str_mv Instituto Oswaldo Cruz, Ministério da Saúde
publisher.none.fl_str_mv Instituto Oswaldo Cruz, Ministério da Saúde
dc.source.none.fl_str_mv Memórias do Instituto Oswaldo Cruz v.113 n.8 2018
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instname_str Fundação Oswaldo Cruz
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repository.name.fl_str_mv Memórias do Instituto Oswaldo Cruz - Fundação Oswaldo Cruz
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