The authorization of the National Health Surveillance Agency (Anvisa) for the sale of covid-19 self-tests should not make a big difference in facing the pandemic in Brazil, because only a small slice of the population will be able to buy the product.
This is the assessment of Reinaldo Guimarães, a public health physician and vice president of the Brazilian Association of Collective Health (Abrasco).
The agency’s decision, this Friday, authorizes that the tests can be marketed in pharmacies, drugstores and other properly licensed health establishments. However, there is no indication from the Jair Bolsonaro government (PL) that the product will also be made available by the Unified Health System (SUS).
“I don’t believe that authorization for the sale of tests will be of great importance in combating the pandemic. Who can afford to buy a test for R$180? Only a small portion of the population, the one with the highest purchasing power. there is no way to pay. Besides, with the high demand, the tendency is for the price of tests to rise”, says the sanitarian.
For him, the self-test should be included in a public policy of the SUS, and distributed free of charge in a broad testing program.
“Other countries that have a healthcare system, like the UK with the NHS, make the tests available for free. population”, he explains.
Although Anvisa’s authorization for the sale of self-tests in pharmacies was given after a request from the Ministry of Health, Minister Marcelo Queiroga recently said that it is “difficult” to incorporate the product into the SUS.
“Without having these answers regarding effectiveness and cost, this policy may not have the result we want. This does not mean that the test cannot be sold in pharmacies so that the population can acquire and perform the test. possible that society can have this access, private networks have also carried out tests”, said the minister, on January 10th.
For Guimarães, another problem will be related to data on infections and epidemiological surveillance.
“If the person is infected and has conscience, he will look for the health system to inform his case. But I find it very difficult for this to happen to most people. Even if he informs, there will be surveillance around that person and with who did she contact? During the pandemic, it became clear that epidemiological surveillance did not work in Brazil”, he says.
The company that wants to market the self-test in pharmacies must still ask for authorization from Anvisa, which will analyze case by case. “As there is pressure from society for celerity, I do not believe that Anvisa will take long to authorize the companies”, says Guimarães.
According to the agency, the expectation is that the first requests for regularization of self-tests should arrive next week. In these processes, companies must present data that show the effectiveness and safety of the products they wish to sell in the country.
It is not yet known what the value of the test in pharmacies will be. Normally, who sets the maximum price for a medicine or medical product is the Medicines Market Regulation Chamber (CMED), an interministerial body responsible for the economic regulation of the medicine market in Brazil – Anvisa plays the role of executive secretary of CMED .
During the session at Anvisa, the agency’s director, Romisson Rodrigues Mota, recalled that the Spanish government set the maximum price for self-test kits in the country at 2.94 euros. The value is equivalent to R$ 17.6. There is, however, no indication that the price in the country may be in this range.
How does the self test work?
In the self-test, the user collects material (which can be saliva or liquid from the nasal cavity) with a kind of cotton swab, places it in a container with reagent and then pours this solution into a kind of box where the result is displayed. In general, the result comes out between 10 and 20 minutes.
– Is this test the same as RT-PCR?
No. The self-tests released by Anvisa are the type that detects whether the user has coronavirus antigens. According to the Ministry of Health, self-tests must have a sensitivity above 80%. Despite being considered safe and accurate, the tests considered “gold standard” are RT-PCR.
– What to do if the result is positive?
The orientation of the Ministry of Health is for the user to look for a nearest health unit or teleservice so that the diagnosis can be confirmed. It is at this point that, if the diagnosis is confirmed, the case will be duly notified to the health authorities. In these situations, the orientation is that the patient goes into isolation immediately.
– What to do if the result is negative?
Here, the orientation will depend on whether or not the user has symptoms. If he does not have symptoms of the disease, the orientation is to observe whether or not they will appear. If the test is negative, but the user is known to have had recent contact with people diagnosed with covid-19, the orientation is that he undergoes an RT-PCR exam.
For users who have symptoms, but the test was negative, the orientation is that they take a new test or look for a health unit for evaluation.
– Can the negative self-test result be used to board international flights?
No. According to the director of Anvisa, Alex Campos Machado, the negative result pointed out in a self-test cannot be used by the user as proof that he is not infected for boarding international flights to countries that require this type of proof.
– Will the positive self-test result be enough to obtain medical leave or leave?
No. According to Anvisa, leave or medical leave due to covid-19 can only occur after analysis by a health professional.
– Will companies be able to buy self-tests and distribute them to employees?
Yes. According to Anvisa, there is no restriction for companies to distribute self-tests to their employees.
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