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: Barbosa Camargo, Erika
• Data de Publicação: 2023
• Outros Autores: Ramos, Maíra Catharina, Tavares Silva Elias, Flávia
• 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
• 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

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.