Covid self-test depends on authorization from Anvisa; experts defend use - ISTOÉ MONEY

Used as a tool to combat the new coronavirus, the so-called covid-19 self-test is already popularly used in the United States and countries in Europe, Asia and Latin America. However, in Brazil, it still has no registration to be sold. Despite being defended by manufacturers, pharmacists and specialists, its use depends on authorization from the National Health Surveillance Agency (Anvisa).

Available for sale in pharmacies and retail stores or distributed by governments in countries where use is permitted, the test can be performed at home. The person only needs to perform a nasal swab sample collection, following the instructions for use. All materials needed to perform the test, such as instructions, cotton swabs, testing devices and reagents are provided in the package. Furthermore, the result can be checked within 15 minutes.

According to the executive president of the Brazilian Chamber of Laboratory Diagnosis (CBDL), Carlos Eduardo Gouvêa, to launch any type of self-test on the market, Anvisa needs to make a specific resolution, usually for reasons of public health need indicated by the Ministry of Health.

“There is already a consensus on the growing importance of new tools, and it is now up to Anvisa to proceed with the same speed that it adopted at the beginning of the pandemic, for an assessment that authorizes the registration process for these products. It is also essential that the Ministry of Health supports this measure, even for the discussion to be very complete and agile”, demanded Gouvêa.

“For this scenario to change, formal provocation by the Ministry of Health is necessary for Anvisa to discuss a possible resolution authorizing the start of registration of such products, stipulating the conditions, requirements and other usability criteria for the lay population” , said the expert.

In turn, Anvisa clarifies that, considering the classification of covid-19 as a compulsory notification disease, the feasibility of using self-test products requires linking to public policies with clearly defined purposes, associated with adequate clinical care and support, and, as the case may be, tracking contacts to break the transmission chain, with a view to defining public health policies and strategic actions formally instituted by the Ministry of Health and agreed with Anvisa. “The expansion of access, including to the lay public, must be studied with criteria regarding the risks, benefits and possible effects”, said, in a note, the regulatory agency.

Also according to Anvisa, other countries that have adopted the approach of performing in vitro tests for covid-19 outside the laboratory environment have sanitary criteria directed to such situations and have established public policies with a view to combating the dissemination of the coronavirus.

According to the agency, one must also 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.

However, as with the HIV self-test, which is now widely available and used as a tool for early access to essential information, the covid-19 self-test is already more than necessary, according to entities.

Should it surpass the 1 billion mark of covid-19 self-tests in the North American territory alone and another billion for distribution to poor or developing countries, according to the projection of the Health Organization (WHO), the discussion for availability is expanded. , as soon as possible, in Brazil.

“The only self-tests that are authorized in the country are blood glucose, pregnancy and HIV tests. At this moment, the covid-19 self-tests would help to relieve the testing centers and laboratories that, with an increase in demand, unfortunately become places of potential agglomeration with risks for everyone”, warned the executive president of CBDL.

In the case of ACT-A Dx, a group in which the entity participates to speed up access to diagnosis, there is also a strong mobilization to support industries in the development of new technologies to detect the SARS-CoV virus even earlier and more safely -two.

“The focus has been heavily on covid-19 self-tests – extremely effective solutions available to all citizens, in addition to other available tools, such as molecular testing (RT-PCR) in laboratories and hospitals or rapid antigen testing , made in pharmacies”, said Gouvêa.

The first difficulty in allowing people to take the test was the lack of knowledge of the importance and value of the diagnosis. “After two years of pandemic, it is no longer a problem. Much of the population already knows that early and accurate diagnosis can lead to more effective therapy – even more so if we consider that 70% of medical decisions are based on diagnosis”, he said.

Also according to the executive president of CBDL, another issue that is discussed is whether lay people would be able to take the test. “At a time of advanced technology where everyone has a smartphone with so many sophisticated applications, modern banking systems that all operate with ease, in addition to one of the most advanced income tax declaration systems, it would be very naive to say that Brazilians don’t is able to read a leaflet and follow the steps indicated therein”, he reinforced.

In addition to the United States, Europe and Asia, countries in Latin America already offer the self-test. The Panbio Covid-19 Ag Self-Test, produced by Abbott, is present in all these locations. This month it arrived in Chile and is being launched in Peru and Paraguay.

“We understand that there is an opportunity to evolve in this assessment, based on other self-tests available on the market, such as the one for HIV. We believe in open dialogue to further expand discussions on this topic in the country”, states, in a statement, the company, which is globally producing more than 100 million rapid tests and covid-19 PCR per month.

Abbott clarified that the Panbio Covid-19 Ag Self Test has the same format as the test for professional use currently available in Brazil (Panbio Covid-19 Ag Rapid Test), but is packaged differently for individual use.

Although he defends the use of the covid-19 self-test in Brazil, Sérgio Mena Barreto, CEO of the Brazilian Association of Pharmacy and Drugstore Chains (Abrafarma), believes that it should be marketed with registration, in the correct sales channel, explanation and support to patients.

“The idea of having the self-test is excellent. We support it, as long as it is well regulated. The big question is the barrier you have for it. The person performs the test at home following their personal protocol, but the test has a very specific protocol to be followed. The great risk of having a self-test for public purposes is having a false positive or false negative result because you were not assisted by a professional and you believe that the result is true”, he said.

Also according to Barreto, the price would also be more affordable. “The typical price of the quick pharmacy test is around R$ 70. The self-test can be sold much cheaper”, he estimated.

In Germany, a Brazilian reports the ease of using the self-test

The use of the covid-19 self-test is already part of the routine of Brazilian Renata Moreira, who has lived in Germany for eight years. “My husband and I do the self-test when we go to visit or welcome someone at home. Or even when we need to go to work. In late 2020, my husband had to take the test. At that time it was very difficult to do any kind of test anywhere. In early 2021, a year ago, it became more common to sell even self-tests.”

Renata also notes that prices end up fluctuating, depending on demand. “With the drop in cases, the product, which cost 5 euros per unit (R$32.25), is now available for 0.50 cents (R$3.22). Now the price has gone up again. “Just before Christmas, we paid 2.40 euros for the last one (R$15.48). Whenever we go to an establishment that sells, we buy when the price is reasonable”, he said.

Although they were not tested positive by the self-test, Renata and her husband know that in case of confirmation, they need to look for a health unit. “People I know who tested positive on the self-test sought medical attention to also do the RT-PCR test. The self-test is very interesting as a screening or even when you are not feeling very well. The packaging says that the test is 80% reliable. Now, if the person has already had contact with an infected person, the indication is also to do the RT-PCR”, he said.

Experts advocate using the self-test

Lauro Ferreira Pinto Neto, infectologist at the Brazilian Society of Infectology (SBI) and professor at the Santa Casa de Vitória School of Medicine, agrees that the covid-19 self-test would be one more tool given the current national scenario and the population’s own concern with diagnosis of the disease.

“The pandemic has changed citizens’ culture a little, as they want to know what they have. There is concern about the risks posed by acute respiratory illness. Whether in the public or private network, if you have covid-19 or flu, for example. Any reliable diagnostic tool is favorable”, he believes.

In the expert’s opinion, a good thing about the pandemic would be to have a greater routine for diagnosing respiratory diseases. “Self-tests and also the greater availability of tests in public and private networks would facilitate patient treatment and avoid unnecessary use of medication, which ended up worsening during the pandemic”, he said.

For Raquel Stucchi, an infectious disease specialist at the State University of Campinas (Unicamp), in addition to the Ministry of Health’s blackout, which does not allow us to know what is happening in the country in terms of exact numbers of cases and hospitalizations, there is also a blackout in relation to testing .

“Offering tests or allowing us to have self-tests would be an extremely important measure for us to increase the diagnosis. Self-testing is carried out in many countries with absolute success, and it is even possible to have traceability with a QR code so that the person can report the data in the Ministry of Health’s system”, he said.

“At this moment, with a significant increase in cases, high demand for covid-19 tests in pharmacies and laboratories and people seeking health facilities – public and private – the availability of disease self-tests would also help to draw an overview of the disease in Brazil” , defended the specialist.