Anvisa approves first self-test for Covid in Brazil

Anvisa (National Health Surveillance Agency) approved the first self-test for Covid-19 this Thursday (17). The registered product is the Novel Coronavirus (Covid-19) Autotest Antigen, from the company CPMH (Commerce and Industry of Hospital and Dental Medical Products).

The regulatory agency authorized the sale of self-tests in Brazil in January. However, each company must apply for registration to market the product.

The self-test is approved for use with a non-deep nasal swab sample with a result after 15 minutes.

According to the evaluation, the product met the technical criteria defined by Anvisa and also had its performance evaluated and approved by the National Institute for Quality Control in Health, as established in the PNE (National Testing Expansion Plan).

“To grant the registration, Anvisa analyzes a series of technical requirements, among which are usability and risk management, which serve to adapt the product for use by lay people, providing greater security in its use”, said in a note to Anvisa.

The self-test will serve to expand the testing of symptomatic and asymptomatic individuals and their possible contacts. In this way, early isolation and breaking the chain of transmission could occur.

As informed in the technical note of the Ministry of Health, the self-test will become a new screening tool for the PNE. Thus, the person with a positive result should seek a health care unit or telecare so that a health professional can confirm the diagnosis, notify and provide relevant guidelines for surveillance and health care.

Thus, it would not be mandatory to report the result of the self-test to the Ministry of Health.

​According to Anvisa’s decision, the self-test can only be marketed in pharmacies with and without manipulation and licensed health establishments. These licensed establishments will also be able to sell online.