Self-test against Covid is barred in Brazil by Anvisa rule

The population can now buy or get free Covid-19 tests to be done at home. At least in the US and Europe. Meanwhile, in Brazil, testing remains focused on clinics, pharmacies and public services.

This type of Covid test is not authorized in Brazil because of a 2015 Anvisa (National Health Surveillance Agency) resolution.

Home self tests are antigen tests. The person himself collects material (with the aid of a swab, as in a normal PCR) and deposits it on a surface that indicates whether he is infected or not.

Antigen tests, which look for Sars-CoV-2 particles, have gained importance in the pandemic because they are simpler, generally faster and also cheaper than PCR, which detects genetic material from the virus. As with PCR, they can have a high capacity for detecting the virus.

Article 15 of Anvisa’s resolution 36 says that products for the purpose of diagnosing the presence or exposure to a transmissible agent, “including agents that cause infectious diseases subject to compulsory notification” cannot be supplied to laypersons.

This would make self-testing for Covid in the country unfeasible, were it not for an exception. The sole paragraph of the same article establishes that the ban “may be removed by Resolution of the Collegiate Board, in view of public policies and strategic actions formally instituted by the Ministry of Health”.

And an exception to this has already occurred. A few years ago, following an initiative by the Ministry of Health, self-tests for HIV were released, which have the support of the WHO (World Health Organization) and PAHO (Pan American Health Organization).

Before that, however, there were fears about the release. According to Claudio Maierovitch Henriques, a health specialist at Fiocruz and president of Anvisa from 2003 to 2005, one of them was regarding possible errors in the use of the exam, which could lead to incorrect results. Another concern was with the impact that the result could have on the person, especially when considering a serious contamination such as HIV.

But with the start of the availability of self-tests, several of these myths ended up falling apart, says Henriques.

Despite this, sought after by leaf, Anvisa reports some of these issues to argue about the non-availability of self-tests for Covid.

According to the agency, diagnostic instruments of this type involve risks that need to be mitigated. The entity states that it is necessary to take into account “the impact related to possible errors in the execution of tests, which, in addition to reverberating in the quality of life of users, can affect public health programs”.

“Therefore, the expansion of access, including the lay public, must be studied with criteria regarding the risks, benefits and possible effects”, says Anvisa.

Fiocruz’s sanitary officer, however, does not see great risks involved in making more tests available. According to him, self-tests would be part of a complementary policy and would be important to reach more people.

Something that both the public health specialist and Anvisa emphasize is that the introduction of self-tests should be a public policy.

In the United Kingdom, for example, the government provides free self-tests, a user manual and indicates suitable situations for use, such as on days when the person will be in high-risk transmission settings.

On the plate where the sample is deposited for testing, there is also a QR Code for notification to the NHS (National Health Service), the British health system.

According to Anvisa, self-tests would have to be associated “with adequate clinical care and support and, as the case may be, contact tracing to break the chain of transmission”.

Home testing should also begin to be used as a public health tool in Denmark. In the country, there will be greater availability of the home exam for children and school workers, with an incentive to take two tests a week, according to the local press, in an attempt to keep teaching units open, despite the growth of cases.

For Raquel Stucchi, a professor at Unicamp and a consultant for the SBI (Sociedade Brasileira de Infectologia), self-tests should be made available by the government and would be extremely important, especially for the current moment of the pandemic in Brazil. “To prevent people from being crowded together in a health unit. This is already happening, both in the public and private sectors”, says Stucchi. “Self-tests make it much faster for diagnosis and isolation.”

Carlos Eduardo Gouvêia, executive president of CBDL (Brazilian Chamber of Laboratory Diagnosis) says that there is no shortage of companies interested in bringing self-tests to Brazil.

A leaf turned to Roche Diagnostics and Abbott, two companies that offer self-tests in the European and American markets.

Abbott says it is willing to bring its home test to Brazil “as soon as it is allowed by Brazilian law” and that it has even presented the self-tests to the government as part of the company’s portfolio.

Roche stated that, in Brazil, its self-test is not commercialized due to the limitation of health legislation.

As for prices for the private market, the companies did not estimate how much self-tests could cost in Brazil. Abbott says, however, that its review was done “with a view to expanding its availability at an affordable price.”

Abroad, this type of test, for places where there is no free distribution, as in the USA, does not have high prices (compared to what is currently available in Brazil).

According to Gouvêia, in a workshop with Anvisa at the end of 2020, the agency was asked about the topic and said that there is a possibility of discussion of release, and that it should be provoked to open the discussion.

The president of CBDL says that there will be an effort from entities and interested parties in the matter to evolve the process. “The ideal would be for the ministry to manifest itself in an official way”, he says.

In a note to leaf, Anvisa also said that “the competence to define Public Health Policies belongs to the Ministry of Health”.

A leaf questioned the Ministry of Health about possible plans to release self-tests for Covid and about the agenda’s view of this possibility. The Pasta responded that it distributes the tests already approved and registered by Anvisa to the states.

“To reinforce the testing of the population, Pasta contracted around 60 million rapid tests produced by the Oswaldo Cruz Foundation (Fiocruz)”, says the ministry.

Real life

The experience of some Brazilians abroad helps to get an idea of ​​how these tests can be used and be useful in everyday life to avoid transmission of Covid.

On Twitter, the health doctor Daniel Dourado reported the detection of Covid, with a self-test, in his four-year-old daughter, shortly before the New Year, in which there would be a family meeting.

“Family meeting obviously cancelled,” Gold posted. “We are testing every day because we came to Brazil for the holidays, we had the possibility to bring many dozen antigen tests that we bought in Europe.”

At the end of the year, Vitor Mori, a physicist and researcher at the University of Vermont (USA), told leaf that he would visit people in Boston and that he would do self-tests. “Every day, we will do a rapid antigen test to ensure that we will not be infected on the day of the trip.”

Mori also says he and his wife even took self-tests when a co-worker of hers tested positive.