Analysis of COVID-19 diagnostic test implementation in Brazil: strategies in place at the beginning of the pandemic

Abstract

The World Health Organization considers the mass testing one of the main tools for controlling the COVID-19 pandemic. The aim of this study was to evaluate the strategies adopted by the Brazilian Federal Government to promote population testing and access to in vitro diagnostic products for COVID-19 within the Unified Health System. Thus, we analyzed the information collected in databases from ANVISA (Brazilian Health Regulatory Agency), the Ministry of Health and Our World in Data on regulatory flexibility for in vitro diagnostic products for COVID-19, the impacts of acquisition and distribution for tests and the pandemic indicators, respectively. Around 65% of the tests registered at ANVISA were from China, while only 17% were Brazilian tests. Of the 441 registered tests, 67.8% were rapid antibody tests. Brazil only carried out 20 million of the 46 million tests planned for 2020 by the Diagnosis to Care Program. The reduced mass testing and the use mainly of rapid tests for antibodies detection may contribute to the underreporting of the disease and to Brazil's position among the countries that test the least and with a high number of cases and deaths presented in the early years of the COVID-19 pandemic.