Registration of technologies during epidemics: analysis of diagnostic tests for Zika virus in Brazil

• Autor(a) principal: Oliveira, Catia Veronica dos Santos
• Data de Publicação: 2022
• Outros Autores: Reis, Lenice Gnocchi da Costa, Pepe, Vera Lúcia Edais
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Revista de Direito Sanitário (Online)
• Texto Completo: https://www.revistas.usp.br/rdisan/article/view/186731
• topic: Agência Nacional de Vigilância Sanitária; Aprovação de Teste Diagnóstico; Brasil; Registro de Produtos; Vírus Zika; Brazilian Health Regulatory Agency; Diagnostic Test Approval; Brazil; Products Registration; Zika Virus

In times of Public Health Emergencies, the use of diagnostic technologies occurs under special conditions, given  the need for quick access. In the Public  Health Emergencies of Zika virus,  commercial tests were important to identify cases and respond to their challenges. In Brazil, commercialization  occurs after registration is granted by  the Brazilian Health Regulatory Agency.  The objective was to analyze the  registration of commercial tests for the  diagnosis of Zika virus infection in Brazil from 2016 to 2019. This exploratory-descriptive study used the database of  the Brazilian Health Regulatory Agency, and documents from the pages of the manufacturers, registration holders and the agency. Four dimensions were considered: registry; tests; manufacturers; and registration  holders. Sixty-eight tests were registered, 91% of which were from private companies, 82% specific to Zika  virus, 54% imported, 78% serological  and 37% rapid tests. During the Public  Health Emergencies of Zika virus, the  Brazilian Health Regulatory Agency prioritized the registration of tests, not using the Emergency Use Authorization, an internationally recommended instrument. The average  time for analyzing the  registration process was shor ter and  the number of requirements was  higher in 2016. No information on performance was identified in 50% of  the tests. The recovery and generation  of new evidence, during use, is a major challenge, and it is important to provide  information on tests  performance.