A straightforward one-step strategy for SARS-CoV-2 diagnosis and screening of variants of concern: a multicenter study

Detalhes bibliográficos
Autor(a) principal: Fontana-Maurell, Marcela
Data de Publicação: 2023
Outros Autores: Motta, Fernando do Couto, Arruda, Monica Barcellos, Cardoso, Pedro, Ribeiro, Marisa, Andrade, Elisabete, Godoy, Daniela T., Costa, Elaine, Rocha, Daniele, Siqueira, Marilda Agudo M. T., Brindeiro, Rodrigo, Alvarez, Patrícia
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/57809
Resumo: Inclui errata.
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spelling Fontana-Maurell, MarcelaMotta, Fernando do CoutoArruda, Monica BarcellosCardoso, PedroRibeiro, MarisaAndrade, ElisabeteGodoy, Daniela T.Costa, ElaineRocha, DanieleSiqueira, Marilda Agudo M. T.Brindeiro, RodrigoAlvarez, Patrícia2023-04-15T18:58:43Z2023-04-15T18:58:43Z2023FONTANA-Maurell, Marcela et al. A straightforward one-step strategy for SARS-CoV-2 diagnosis and screening of variants of concern: a multicenter study. Memórias do Instituto Oswaldo Cruz, Rio de Janeiro, v. 118, p. 1-8, 2023.1678-8070https://www.arca.fiocruz.br/handle/icict/5780910.1590/0074-02760220202Inclui errata.The Collaborative Study Group: Adriano Abbud, Claudio Tavares Sacchi, Karoline Rodrigues Campos (Adolfo Lutz Institute); Ana Flávia Mendonça, Luiz Augusto Pereira (Central Laboratory - Goiás); Jaqueline Pegoretti Goulart, Anna Clara Gregório Có (Central Laboratory - Espírito Santo); Lidio Gonçalves Lima Neto, Hivylla Lorrana dos Santos Ferreira (Central Laboratory - Maranhão); Maria do Carmo Debur, Guilherme Nardi Becker (Central Laboratory - Paraná); Tatiana Schaffer Gregianini, Richard Steiner Salvato (Central Laboratory - Rio Grande do Sul); Sandra Bianchini Fernandes, Darcita Buerger Rovaris (Central Laboratory - Santa Catarina); Andreia Santos Costa, Márcia Socorro Pereira Cavalcante (Central Laboratory - Amapá); Mirleide Cordeiro dos Santos, Luana Soares Barbagelata (Evandro Chagas Institute); Yasmin Santos Freitas Macêdo, Tiago Gräf (Fundação Oswaldo Cruz. Instituto Gonçalo Muniz. Salvador, BA, Brasil); Fabio Miyajima, Carlos Leonardo de Aragão Araujo, Joaquim Cesar do Nascimento Sousa Junior (Fundação Oswaldo Cruz. Fiocruz Ceará. Fortaleza, CE, Brasil).Fundação Oswaldo Cruz. Instituto de Tecnologia de Imunobiológicos Bio-Manguinhos. Rio de Janeiro, RJ, Brasil / Universidade Federal do Rio de Janeiro. Departamento de Genética. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Vírus Respiratório e Sarampo. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia de Imunobiológicos Bio-Manguinhos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia de Imunobiológicos Bio-Manguinhos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia de Imunobiológicos Bio-Manguinhos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia de Imunobiológicos Bio-Manguinhos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia de Imunobiológicos Bio-Manguinhos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia de Imunobiológicos Bio-Manguinhos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia de Imunobiológicos Bio-Manguinhos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Vírus Respiratório e Sarampo. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia de Imunobiológicos Bio-Manguinhos. Rio de Janeiro, RJ, Brasil / Universidade Federal do Rio de Janeiro. Departamento de Genética. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia de Imunobiológicos Bio-Manguinhos. Rio de Janeiro, RJ, Brasil.BACKGROUND The prevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants of concern (VOCs) has changed unevenly over time around the world. Although whole genome sequencing is the gold standard for virus characterisation, the discovery of alpha VOC causing spike gene target failure (SGTF) result, when tested using an reverse transcription real-time polymerase chain reaction (RT-qPCR) assay, has provided a simple tool for tracking the frequencies of variants. OBJECTIVES The aim of this study was to investigate if a multiplex RT-qPCR assay (BioM 4Plex VOC) could be used to detect SARS-CoV-2 and to perform a VOC screening test in a single reaction tube. Here, we present the multicentre study evaluating this assay. METHODS Twelve laboratories have participated in the multicentre study. The BioM 4Plex VOC was distributed to them with detailed instructions of how to perform the test. They were asked to test the BioM 4Plex VOC in parallel with their routine Commercial SARS-CoV-2 diagnostic assay. Additionally, they were requested to select SARS-CoV-2-positive samples with genome sequenced and lineage definition according to PANGO lineage classification. FINDINGS The BioM 4Plex VOC and commercial RT-PCR assay are equally effective in detecting SARS-CoV-2. Results revealed a specificity of 96.5-100% [95% confidence interval (CI)], a sensitivity of 99.8-100% (95% CI), and an accuracy of 99.8-100% (95% CI). A 99% concordance rate was found between results from the BioM 4Plex VOC and that from available genome sequencing data. MAIN CONCLUSIONS The BioM 4Plex VOC provides an effective solution to detect SARS-CoV-2 infections and screening for VOCs in a single reaction. It is a straightforward method to help us monitor the frequency and distribution of VOCs and develop strategies to better cope with the pandemics.engFiocruz/IOChttps://www.arca.fiocruz.br/handle/icict/57026Diagnóstico SARS-CoV-2COVID-19Variantes de PreocupaçãoVigilância epidemiológicaSARS-CoV-2 diagnosisCOVID-19Variants of ConcernEpidemiological surveillanceA straightforward one-step strategy for SARS-CoV-2 diagnosis and screening of variants of concern: a multicenter studyinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; 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dc.title.en_US.fl_str_mv A straightforward one-step strategy for SARS-CoV-2 diagnosis and screening of variants of concern: a multicenter study
title A straightforward one-step strategy for SARS-CoV-2 diagnosis and screening of variants of concern: a multicenter study
spellingShingle A straightforward one-step strategy for SARS-CoV-2 diagnosis and screening of variants of concern: a multicenter study
Fontana-Maurell, Marcela
Diagnóstico SARS-CoV-2
COVID-19
Variantes de Preocupação
Vigilância epidemiológica
SARS-CoV-2 diagnosis
COVID-19
Variants of Concern
Epidemiological surveillance
title_short A straightforward one-step strategy for SARS-CoV-2 diagnosis and screening of variants of concern: a multicenter study
title_full A straightforward one-step strategy for SARS-CoV-2 diagnosis and screening of variants of concern: a multicenter study
title_fullStr A straightforward one-step strategy for SARS-CoV-2 diagnosis and screening of variants of concern: a multicenter study
title_full_unstemmed A straightforward one-step strategy for SARS-CoV-2 diagnosis and screening of variants of concern: a multicenter study
title_sort A straightforward one-step strategy for SARS-CoV-2 diagnosis and screening of variants of concern: a multicenter study
author Fontana-Maurell, Marcela
author_facet Fontana-Maurell, Marcela
Motta, Fernando do Couto
Arruda, Monica Barcellos
Cardoso, Pedro
Ribeiro, Marisa
Andrade, Elisabete
Godoy, Daniela T.
Costa, Elaine
Rocha, Daniele
Siqueira, Marilda Agudo M. T.
Brindeiro, Rodrigo
Alvarez, Patrícia
author_role author
author2 Motta, Fernando do Couto
Arruda, Monica Barcellos
Cardoso, Pedro
Ribeiro, Marisa
Andrade, Elisabete
Godoy, Daniela T.
Costa, Elaine
Rocha, Daniele
Siqueira, Marilda Agudo M. T.
Brindeiro, Rodrigo
Alvarez, Patrícia
author2_role author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Fontana-Maurell, Marcela
Motta, Fernando do Couto
Arruda, Monica Barcellos
Cardoso, Pedro
Ribeiro, Marisa
Andrade, Elisabete
Godoy, Daniela T.
Costa, Elaine
Rocha, Daniele
Siqueira, Marilda Agudo M. T.
Brindeiro, Rodrigo
Alvarez, Patrícia
dc.subject.other.en_US.fl_str_mv Diagnóstico SARS-CoV-2
COVID-19
Variantes de Preocupação
Vigilância epidemiológica
topic Diagnóstico SARS-CoV-2
COVID-19
Variantes de Preocupação
Vigilância epidemiológica
SARS-CoV-2 diagnosis
COVID-19
Variants of Concern
Epidemiological surveillance
dc.subject.en.en_US.fl_str_mv SARS-CoV-2 diagnosis
COVID-19
Variants of Concern
Epidemiological surveillance
description Inclui errata.
publishDate 2023
dc.date.accessioned.fl_str_mv 2023-04-15T18:58:43Z
dc.date.available.fl_str_mv 2023-04-15T18:58:43Z
dc.date.issued.fl_str_mv 2023
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv FONTANA-Maurell, Marcela et al. A straightforward one-step strategy for SARS-CoV-2 diagnosis and screening of variants of concern: a multicenter study. Memórias do Instituto Oswaldo Cruz, Rio de Janeiro, v. 118, p. 1-8, 2023.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/57809
dc.identifier.issn.en_US.fl_str_mv 1678-8070
dc.identifier.doi.none.fl_str_mv 10.1590/0074-02760220202
identifier_str_mv FONTANA-Maurell, Marcela et al. A straightforward one-step strategy for SARS-CoV-2 diagnosis and screening of variants of concern: a multicenter study. Memórias do Instituto Oswaldo Cruz, Rio de Janeiro, v. 118, p. 1-8, 2023.
1678-8070
10.1590/0074-02760220202
url https://www.arca.fiocruz.br/handle/icict/57809
dc.language.iso.fl_str_mv eng
language eng
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eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Fiocruz/IOC
publisher.none.fl_str_mv Fiocruz/IOC
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
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