With the COVID-19 pandemic, many diagnostic tests (molecular or immunological) were rapidly standardised, given the urgency of the situation, many are still in the process of being validated. The main objective of this study was to review the aspects of the diagnostic kits approved in Brazil and their application in the different federative units to gather epidemiological information. In order to achieve these objectives, a survey was carried out on the data available at the regulatory agency (ANVISA) and in the literature. The main countries that have registered products in Brazil are China (51.4%), Brazil (16.6%), South Korea (9.2%), USA (8.8%) and Germany (3.6%). The methodologies of these products are based on the detection of nucleic-acid (15.8%), antigen (13%) and antibody (71.2%). In the immunological tests, it was verified that the sensitivity ranged from 55 to 100% and the specificity from 80 to 100%. The percentage of cases in the samples tested in Brazil is elevated in almost all federative units since eight states showed 40% of positive cases in tested samples, while 18 states displayed between 20 and 40%. In conclusion, this review showed
HIGHLIGHTS The main COVID-19 diagnostic methods in Brazil are updated. More than 80% of the approved products are from other countries. The tests are based on the detection of nucleic-acid (15.8%), antigen (13%) and antibody (71.2%). The most of Brazilian federative units show an elevated percentage of cases per samples tested. 2 Vedova-Costa J.M.D.; et al.
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