Monitoramento pós-mercado dos testes rápidos para detecção de antígenos da COVID-19 no enfrentamento à pandemia

Abstract

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.