Anvisa should release the use of Covid self-test in Brazil on Friday

The collegiate board of Anvisa (National Health Surveillance Agency) should approve next Friday (28) the use of the Covid-19 self-test in Brazil.

On the 19th, the agency decided by 4 votes to 1 to postpone the decision and ask for more data from the Ministry of Health.

The portfolio led by Minister Marcelo Queiroga sent on Tuesday night (25) a new technical note with a public policy proposal for the use of the exam. In the document, the folder pointed out that the product should serve as a screening tool for Covid-19.

The trend is that the use of the self-test is now released by the agency, according to members of Anvisa who follow the discussion.

According to the Health proposal, anyone who receives an indication that they are infected should seek a health care unit or seek the teleservice service so that a health professional can confirm the diagnosis and provide guidance.

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 entities demanded, in early January, 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.

The use of self-tests is vetoed by a 2015 Anvisa resolution. By rule, the ministry must propose a public policy to allow the delivery of exams to the lay public.

The proposal of Health is that the self-test is sold only in pharmacies.

Minister Queiroga said, on the 14th, that the self-test can relieve health units, but signaled that the product should not be purchased by the government and distributed in the SUS.

“Brazil is a very heterogeneous country, with many contrasts. The allocation of this resource for acquiring self-tests, distributing them to the general population, may not have resulted in the public policy that we expect”, said Queiroga.

Health states that the PNE (National Testing Expansion Plan for Covid-19) self-test.

“With the citizen testing himself and, if positive, the identification of Covid-19 cases and self-isolation is increased. The main objective is to expand the population’s access to one more test to identify contaminated people, carry out isolation, reduce the spread of the SARS-Cov-2 virus and thus interrupt the chain of transmission of Covid-19 and the pandemic”, says Saúde in the technical note sent to Anvisa.

Saúde states that this type of test should not be used as a substitute for RT-PCR or antigen tests on international trips or to justify absence from work.

The product is also not yet indicated to define a diagnosis and for people with severe symptoms, such as shortness of breath, saturation below 95%, mental confusion, signs of dehydration. These people need to immediately seek assistance at a health facility, the ministry said.

As the exam should serve for screening, the folder also highlighted that it would not be mandatory to report the result of the self-test to SUS.

In the package insert, companies must provide guidelines on the best time to perform the exam, which, in general, is from the 1st to the 7th day of the onset of symptoms. For those who do not show signs of the disease, the exam should be done from the 5th day of contact with a confirmed case, says Saúde.

The package insert must also inform that the Health Dial, by phone 136, of the Ministry of Health, will be prepared to inform about signs and symptoms related to Covid-19.

The company that requests the test registration must also provide the user with a telephone communication channel to guide and forward the interested party’s demands about the product.

Saúde also recommends that companies can choose whether or not to provide a system for recording test results.