Evidence and regulation for COVID-19 self-tests: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02063 | Published on: 27/02/2023
Autor(a) principal: | |
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Data de Publicação: | 2023 |
Outros Autores: | , |
Tipo de documento: | Artigo |
Idioma: | por eng |
Título da fonte: | Vigilância Sanitária em Debate |
Texto Completo: | https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2063 |
Resumo: | Introduction: The development of new diagnostic tests for SARS-CoV-2 is a strategic component for the prevention and control of COVID-19. To regulate the market for SARSCoV-2 antigen detection self-tests, the regulatory agency issued a resolution that provided for the introduction of self-tests in Brazil. Objective: To perform a comparison between thenew technical requirements of antigen self-tests for COVID-19 with data and information available in the literature. Method: This is a systematic literature review to carry out a comparative study between the scientific evidence and the new technical requirements for the commercialization of antigen self-tests for COVID-19 in Brazil. The search was performed in October 2021, and updated in January 2022. Results: Of the 517 studies identified, nine were included. The studies reported adequate sensitivity and specificity results for most self-tests performed in symptomatic people. The studies bring a variety of tests available and one of them was registered for commercialization in Brazil. Based on this outcome, national regulation follows standards that favor the promotion of self-monitoring by the population, which can contribute to a public health policy. Conclusions: The technical requirements contained in the new regulation and at the national level are consistent with the evidence found, which ensures reliability for decision-making by consumers, clinicians and service providers. It is necessary to continue with studies on self-test coverage for new variants, biological material disposal policies and how the use of self-tests can contribute to the role of consumers in health surveillance actions. |
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Evidence and regulation for COVID-19 self-tests: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02063 | Published on: 27/02/2023Evidências e regulação para autotestes de COVID-19: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02063 | Publicado em: 27/02/2023COVID-19SARS-CoV-2AutotesteTestes DomiciliaresRegulaçãoCovid-19AutotestesRevisãoCOVID-19SARS-CoV-2Self-testingHome Based TestingRegulationIntroduction: The development of new diagnostic tests for SARS-CoV-2 is a strategic component for the prevention and control of COVID-19. To regulate the market for SARSCoV-2 antigen detection self-tests, the regulatory agency issued a resolution that provided for the introduction of self-tests in Brazil. Objective: To perform a comparison between thenew technical requirements of antigen self-tests for COVID-19 with data and information available in the literature. Method: This is a systematic literature review to carry out a comparative study between the scientific evidence and the new technical requirements for the commercialization of antigen self-tests for COVID-19 in Brazil. The search was performed in October 2021, and updated in January 2022. Results: Of the 517 studies identified, nine were included. The studies reported adequate sensitivity and specificity results for most self-tests performed in symptomatic people. The studies bring a variety of tests available and one of them was registered for commercialization in Brazil. Based on this outcome, national regulation follows standards that favor the promotion of self-monitoring by the population, which can contribute to a public health policy. Conclusions: The technical requirements contained in the new regulation and at the national level are consistent with the evidence found, which ensures reliability for decision-making by consumers, clinicians and service providers. It is necessary to continue with studies on self-test coverage for new variants, biological material disposal policies and how the use of self-tests can contribute to the role of consumers in health surveillance actions.Introdução: O desenvolvimento de novos testes diagnósticos para o vírus SARS-CoV-2 é uma etapa estratégica para a prevenção e o controle da COVID-19. Para regular o mercado dos autotestes de detecção de antígenos do SARS-CoV-2, a agência regulatória brasileira emitiu resolução que oportunizou a introdução de autotestes no Brasil. Objetivo: Realizar uma comparação entre os novos requisitos técnicos de autotestes de antígeno para a COVID-19 com dados e informações disponíveis na literatura. Método: Trata-se de uma revisão sistemática da literatura para a realização de um estudo comparativo entre as evidências científicas e os novos requisitos técnicos para comercialização de autotestes de antígeno para COVID-19 no Brasil. A busca foi realizada em outubro de 2021 e atualizada em janeiro de 2022. Resultados: Dos 517 estudos identificados, nove foram incluídos. Os estudos reportaram resultados de sensibilidade e especificidade adequados para maioria dos autotestes realizados em pessoas sintomáticas. Os estudos trazem uma variedade de testes disponíveis e um deles foi registrado para comercialização no Brasil. Baseados nesse desfecho, a regulação nacional segue os padrões que favorecem a promoção de automonitoramento por parte da população, o que pode contribuir para uma política de saúde pública. Conclusões: Os requisitos técnicos contidos na nova regulação e no plano nacional estão condizentes com as evidências encontradas, o que assegura confiabilidade para a tomada de decisão tanto dos consumidores, clínicos e prestadores de serviços. Necessário continuar com estudos sobre cobertura de autotestes para novas variantes, políticas de descarte de material biológico e como o uso de autotestes podem contribuir para o papel dos consumidores nas ações de vigilância em saúde.Instituto Nacional de Controle de Qualidade em Saúde2023-02-27info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfapplication/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/206310.22239/2317-269x.02063Health Surveillance under Debate: Society, Science & Technology ; v. 11 (2023) | Continuous publication; 1-9Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; v. 11 (2023) | Publicación continua; 1-9Vigil Sanit Debate, Rio de Janeiro; v. 11 (2023) | Publicação contínua; 1-92317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2063/1487https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2063/1600https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2063/1532https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2063/1533https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2063/1534Copyright (c) 2023 Erika Barbosa Camargo, Maíra Catharina Ramos, Flávia Tavares Silva Elias (Autor)https://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessBarbosa Camargo, ErikaRamos, Maíra CatharinaTavares Silva Elias, Flávia2024-02-15T18:08:17Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/2063Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2024-02-15T18:08:17Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false |
dc.title.none.fl_str_mv |
Evidence and regulation for COVID-19 self-tests: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02063 | Published on: 27/02/2023 Evidências e regulação para autotestes de COVID-19: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02063 | Publicado em: 27/02/2023 |
title |
Evidence and regulation for COVID-19 self-tests: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02063 | Published on: 27/02/2023 |
spellingShingle |
Evidence and regulation for COVID-19 self-tests: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02063 | Published on: 27/02/2023 Barbosa Camargo, Erika COVID-19 SARS-CoV-2 Autoteste Testes Domiciliares Regulação Covid-19 Autotestes Revisão COVID-19 SARS-CoV-2 Self-testing Home Based Testing Regulation |
title_short |
Evidence and regulation for COVID-19 self-tests: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02063 | Published on: 27/02/2023 |
title_full |
Evidence and regulation for COVID-19 self-tests: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02063 | Published on: 27/02/2023 |
title_fullStr |
Evidence and regulation for COVID-19 self-tests: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02063 | Published on: 27/02/2023 |
title_full_unstemmed |
Evidence and regulation for COVID-19 self-tests: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02063 | Published on: 27/02/2023 |
title_sort |
Evidence and regulation for COVID-19 self-tests: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02063 | Published on: 27/02/2023 |
author |
Barbosa Camargo, Erika |
author_facet |
Barbosa Camargo, Erika Ramos, Maíra Catharina Tavares Silva Elias, Flávia |
author_role |
author |
author2 |
Ramos, Maíra Catharina Tavares Silva Elias, Flávia |
author2_role |
author author |
dc.contributor.author.fl_str_mv |
Barbosa Camargo, Erika Ramos, Maíra Catharina Tavares Silva Elias, Flávia |
dc.subject.por.fl_str_mv |
COVID-19 SARS-CoV-2 Autoteste Testes Domiciliares Regulação Covid-19 Autotestes Revisão COVID-19 SARS-CoV-2 Self-testing Home Based Testing Regulation |
topic |
COVID-19 SARS-CoV-2 Autoteste Testes Domiciliares Regulação Covid-19 Autotestes Revisão COVID-19 SARS-CoV-2 Self-testing Home Based Testing Regulation |
description |
Introduction: The development of new diagnostic tests for SARS-CoV-2 is a strategic component for the prevention and control of COVID-19. To regulate the market for SARSCoV-2 antigen detection self-tests, the regulatory agency issued a resolution that provided for the introduction of self-tests in Brazil. Objective: To perform a comparison between thenew technical requirements of antigen self-tests for COVID-19 with data and information available in the literature. Method: This is a systematic literature review to carry out a comparative study between the scientific evidence and the new technical requirements for the commercialization of antigen self-tests for COVID-19 in Brazil. The search was performed in October 2021, and updated in January 2022. Results: Of the 517 studies identified, nine were included. The studies reported adequate sensitivity and specificity results for most self-tests performed in symptomatic people. The studies bring a variety of tests available and one of them was registered for commercialization in Brazil. Based on this outcome, national regulation follows standards that favor the promotion of self-monitoring by the population, which can contribute to a public health policy. Conclusions: The technical requirements contained in the new regulation and at the national level are consistent with the evidence found, which ensures reliability for decision-making by consumers, clinicians and service providers. It is necessary to continue with studies on self-test coverage for new variants, biological material disposal policies and how the use of self-tests can contribute to the role of consumers in health surveillance actions. |
publishDate |
2023 |
dc.date.none.fl_str_mv |
2023-02-27 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion "Peer-reviewed article" "Artículo revisado por pares" "Artigo avaliado pelos pares" |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2063 10.22239/2317-269x.02063 |
url |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2063 |
identifier_str_mv |
10.22239/2317-269x.02063 |
dc.language.iso.fl_str_mv |
por eng |
language |
por eng |
dc.relation.none.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2063/1487 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2063/1600 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2063/1532 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2063/1533 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2063/1534 |
dc.rights.driver.fl_str_mv |
Copyright (c) 2023 Erika Barbosa Camargo, Maíra Catharina Ramos, Flávia Tavares Silva Elias (Autor) https://creativecommons.org/licenses/by/4.0 info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Copyright (c) 2023 Erika Barbosa Camargo, Maíra Catharina Ramos, Flávia Tavares Silva Elias (Autor) https://creativecommons.org/licenses/by/4.0 |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf application/pdf |
dc.publisher.none.fl_str_mv |
Instituto Nacional de Controle de Qualidade em Saúde |
publisher.none.fl_str_mv |
Instituto Nacional de Controle de Qualidade em Saúde |
dc.source.none.fl_str_mv |
Health Surveillance under Debate: Society, Science & Technology ; v. 11 (2023) | Continuous publication; 1-9 Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; v. 11 (2023) | Publicación continua; 1-9 Vigil Sanit Debate, Rio de Janeiro; v. 11 (2023) | Publicação contínua; 1-9 2317-269X reponame:Vigilância Sanitária em Debate instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
instname_str |
Fundação Oswaldo Cruz (FIOCRUZ) |
instacron_str |
FIOCRUZ |
institution |
FIOCRUZ |
reponame_str |
Vigilância Sanitária em Debate |
collection |
Vigilância Sanitária em Debate |
repository.name.fl_str_mv |
Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ) |
repository.mail.fl_str_mv |
incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br |
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