Post-market monitoring of rapid tests for detecting COVID-19 antigens in combating the pandemic
Vigil Sanit Debate, Rio de Janeiro, 2024, v.12: e02184 | Published on: 04/12/2024
DOI:
https://doi.org/10.22239/2317-269X.02184Keywords:
COVID-19, SARS-CoV-2, Test for SARS-CoV-2 Antigen, Post-market MonitoringAbstract
Introduction: Since the identification of atypical pneumonia of unknown etiology in Wuhan, China, in December 2019, called COVID-19, the disease caused by SARS-CoV-2 requires scientists and governments to take urgent and decisive measures for monitoring and control. Objective: To present the results of post-market monitoring of COVID-19 rapid antigen detection tests (AgTR) regarding clinical or diagnostic sensitivity and specificity. Method: Analysis of AgTR performance results were made available on the electronic panel of Microsoft® Power BI platform on the Brazilian National Health Surveillance Agency (Anvisa) portal from 04/06/2020 to 12/28/2021. Results: 504 results relating to performance analysis were identified: 366 (72.6%) rapid tests (RT), 56 (11.0%) chemiluminescence tests, 31 (6.15%) molecular tests, 22 (4.4%) immunoenzymatic assays, and 29 (5.7%) auxiliary products for the diagnosis of COVID-19. Of the 366 RT results, 304 (83.1%) were RT for antibody detection (AcTR) and 62 (16.9%) were AgTR. Of the 62 AgTR monitored, 49 (79.1%) presented compliant results and 13 (20.9%) did not. The 62 AgTR results corresponded to 50 lots from 42 manufacturers. Conclusions: Monitoring post-market products in compliance with RDC No. 379/2020 enabled the analysis and monitoring of COVID-19 tests. The analyses carried out (guidance and fiscal) in accordance with current legislation (Law No. 6360/1976, Law No. 6437/1977) guaranteed the transparency of the process and reinforced the precepts of health surveillance regarding resolving or preventing health risks. Non-compliant products were not sold, thus guaranteeing the safety and effectiveness of the tests available in the country.
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Gabrielle Rodrigues Conceição, Laboratório de Sangue e Hemoderivados, Departamento de Imunologia, Instituto Nacional de Controle de Qualidade em Saúde, Fundação Oswaldo Cruz (INCQS/ Fiocruz), Rio de Janeiro, RJ, Brasil
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Helena Cristina Balthazar Guedes Borges, Laboratório de Sangue e Hemoderivados, Departamento de Imunologia, Instituto Nacional de Controle de Qualidade em Saúde, Fundação Oswaldo Cruz (INCQS/ Fiocruz), Rio de Janeiro, RJ, Brasil
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Marisa Coelho Adati Adati, Laboratório de Sangue e Hemoderivados, Departamento de Imunologia, Instituto Nacional de Controle de Qualidade em Saúde, Fundação Oswaldo Cruz (INCQS/ Fiocruz), Rio de Janeiro, RJ, Brasil
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