Monitoramento pós-mercado dos testes rápidos para detecção de anticorpos da COVID-19: análise de dados da plataforma Microsoft® Power Bi

Abstract

Introduction: The COVID-19 outbreak caused by a new type of coronavirus was confirmed by Chinese authorities on January 7, 2020, resulting in hundreds of deaths worldwide. Due to the rapid spread of the disease, the World Health Organization (WHO) declared a Public Health Emergency of International Concern on January 30, 2020, and later declared it a pandemic on March 11, 2020. In response to the public health emergency, the National Health Surveillance Agency (Anvisa) in Brazil published Collegiate Board Resolutions (RDCs) No. 379/2020 and RDC No. 445/2020. These regulations established the laboratory analysis of products for in vitro diagnosis by the National Institute for Quality Control in Health (INCQS). Objective: The purpose of this study was to evaluate the performance data of rapid tests for the detection (AcTR) of  COVID-19 antibodies on the Microsoft ® Power Bi platform on the Anvisa portal. Method: The evaluation period was from April 6, 2020, to December 28, 2021. Results: Out of 293 batches of AcTR products evaluated, 55.3% were found to be compliant, while 44.7% were non-compliant according to the established analysis criteria. Conclusions: The main reason for non compliance was reduced sensitivity of the tests. Post-market monitoring was conducted to ensure the availability of quality, safe, and effective products in the Brazilian market and to support decision-making by Brazilian authorities.