Anvisa approves sale of Covid self-test in Brazil

The collegiate board of Anvisa (National Health Surveillance Agency) unanimously authorized the sale of self-test in Brazil as a form of screening for Covid-19. However, this will not happen immediately – each company will need to apply for registration with the regulatory agency to market the product.

The decision came after the Ministry of Health sent a new technical note with a public policy proposal for the use of the exam on Tuesday night (25).

Anvisa did not approve the sale of Covid-19 self-tests in Brazil on January 19. The reading at the time was that the technical note from the Ministry of Health had gaps, for example, on how to notify the confirmation of infection and how to guide patients.

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.

The Ministry of Health has already signaled that it does not intend to buy the self-test to distribute to the population. But it approves its commercialization in the country to expand the testing policy.

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.

The general manager of Health Products Technology, Leandro Rodrigues, stated that it is possible that the agency will authorize a self-test in February. The information was given in a press conference after the approval of the sale of the product.

“We are expecting to receive the first processes of self-test registrations at the beginning of next week and start the analysis. The analysis will start immediately in priority and imagine that during the month of February we will already have products approved”, he said. Rodrigues.

Like leaf showed, the sector is already preparing to serve the market. The executive president of CBDL (Brazilian Chamber of Laboratory Diagnosis), Carlos Gouvêa, estimated that the industry installed in Brazil has the capacity to produce up to 10 million Covid self-tests per month.

He also said that self-tests should be cheaper than antigen tests sold in the pharmacy.

It was agreed between Anvisa and the Ministry of Health that guidelines on self-testing will be included in a new chapter of the PNE (National Testing Expansion Plan for Covid-19).

“The use of self-test for Sars-Cov-2 antigen research will become part of the public policy of the Ministry of Health to combat the Covid-19 pandemic as an axis of support for diagnosis”, said director Rômison Mota.

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.

The reporting director, Cristiane Rose Jourdan Gomes, highlighted that the self-test will serve to expand the testing of symptomatic and asymptomatic individuals and their possible contacts, regardless of vaccination status.

For children under 14 years of age, the examination must be carried out under parental supervision and support. In this way, early isolation and breaking the chain of transmission could occur.

“Considering the exponential increase in cases due to the omicron variant, the elaboration of the Ministry of Health guidelines on the use of self-test related to the testing policy for Covid and Anvisa’s institutional mission to protect public health, I believe it is relevant and urgent the opening of the regulatory process and deliberation of the collegiate board that provides for the registration and self-test devices”, he said.

The release comes at a time when there is an explosion in demand for Covid-19 tests with the advancement of the omicron variant. Private laboratories have reported a lack of tests.

Testing in Brazil is centered on clinics, pharmacies and public services, which are not able to meet the demand due to the circulation of the omicron.

Scientific bodies have urged a broader testing policy from the federal government and permission to test at home. The demand for tests soared with the advance of contamination at the turn of the year.