Anvisa wants to release Covid self-test in the next few days – 01/14/2022 – Equilíbrio e Saúde

Anvisa (National Health Surveillance Agency) works to regulate in the coming days the permission to use the Covid-19 self-test in Brazil.

Pressured by the explosion in demand for exams caused by the advancement of the omicron variant of the new coronavirus, the Ministry of Health asked this Thursday (13) for the agency to release the exam that can be done at home.

Agency technicians work on a resolution that needs to be approved by the agency’s Collegiate Board. Traditionally, a meeting between the directors is called to vote on these texts.

As the topic is considered urgent, the resolution can be published “ad referendum”, that is, it would go into effect soon and the content would be endorsed on another occasion by the board.

In this abbreviated rite, agency technicians were trying to finalize the resolution this Friday (14), but the details of the text are still being closed. The idea is not to let the topic linger and release a resolution no later than the beginning of next week.

The date of publication or voting of the document is still under discussion at the agency. Technicians say that the resolution must be done with caution, as it will guide the self-test market. If it has flaws, it can lead to judicialization or even bar the entry of some exam models.

Agency members still consider that the technical note sent by the ministry has gaps, for example, in guidelines on the notification of positive results and isolation of contacts of those who are infected.

Testing in Brazil is focused on clinics, pharmacies and public services, which are unable to meet the demand due to the circulation of the Ômicron variant.

Used for months in other countries, self-tests are prohibited in the country because of a 2015 Anvisa resolution. By rule, the ministry needs to propose a public policy to release the delivery of exams to the lay public.

The Minister of Health, Marcelo Queiroga, said this Friday that the self-test can help to unburden health units, but signaled that the products should not be purchased by the federal government.

“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”, the minister told the press.

Executive President of CBDL (Brazilian Chamber of Laboratory Diagnosis), Carlos Gouvêa told leaf that self-tests should be cheaper than over-the-counter antigen tests. “Today we see values ​​from R$ 70 to R$ 150 (of antigen tests) in pharmacies. The self-test should be from R$ 45 to R$ 70”, says Gouvêa.

In the proposal sent to Anvisa, the ministry advises that patients who have detected the infection by self-test seek care at a health unit or teleservice to confirm the diagnosis and receive guidance.

According to the same note, self-testing is an additional strategy to prevent and interrupt the chain of transmission of Covid-19, along with vaccination, the use of masks and social distancing.

“The main objective is to expand the access of the population in order to identify contaminated people, guide isolation and thus reduce the spread of the Sars-CoV-2 virus and the pandemic”, says Saúde.

Scientific entities demanded on Tuesday (11) a broader testing policy and permission to test at home. The demand for tests soared with the advance of contamination at the turn of the year.

In a note released on Wednesday (12), Abramed (Brazilian Association of Diagnostic Medicine) warned of the risk of lack of necessary supplies in Covid-19 exams. The entity recommended prioritization of exams to patients “according to a severity scale”.

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