The release of covid-19 self-tests advocated by the Ministry of Health provides for exclusive sale in pharmacies. The proposal is among the complementary information sent to Anvisa on Tuesday night, 25th. There is no mention of the item’s distribution by the Unified Health System (SUS).
+ Ministry sends Anvisa information about covid-19 self-tests
The document indicates that the person with a positive self-test result (done at home, with nasal or saliva collection and a result around 10 to 20 minutes) should seek a health care unit or a teleservice, “so that a professional of health, through the strategies already put in place by the Ministry of Health, carry out the confirmation of the diagnosis, notification and relevant guidelines for surveillance and health care”. In addition, the citizen must isolate himself immediately.
The result is treated as a form of “screening” and, therefore, will not be considered as proof of sick leave, for example. Notification of the positive result and subsequent official registration will only occur if the person seeks medical attention. The indication is for people with mild symptoms, while those with severe symptoms need to seek medical attention immediately. Although it is not mandatory, the ministry recommends that the manufacturer make available a system for recording results over the internet.
“Although all individuals who obtain a positive/reactive result in the self-test, should seek an evaluation by health professionals in the care network and are notified there in the e-SUS system, it is of paramount importance that the registration of self-test results of positive cases and negative tests can be carried out systematically in some type of system offered by the manufacturer”, says the document. “These data must have access permission or be passed on to municipal, state and federal managers.”
In a note, Anvisa confirmed the receipt of additional information and stated that “it will analyze and adjust the proposal to the text of the resolution already worked on, submit it to the Prosecutor’s Office for analysis and deliberate”, with a conclusion “in the shortest and best time possible”. In previous deliberations, the agency expressed the need to send additional data. If released, self-tests will be included in the National Testing Expansion Plan for Covid-19, which does not necessarily imply free distribution.
According to the ministry, the purpose of the release is to expand testing methods, encourage early isolation and allow the identification of the end of the disease transmission period (with a negative result after isolation). Part of the information is in an order signed by the extraordinary secretary for the fight against Covid-19, Rosana Leite de Melo, available on a government digital platform.
In the document, some questions from Anvisa are answered, but not always objectively. Regarding the agency’s question about updating the national testing policy with the inclusion of self-tests, for example, the answer involves a discussion on interpretations of the term “public policies” and a history of government actions in relation to testing during the pandemic. .
It is highlighted that the self-test is indicated for any citizen and that “it must result from a free and autonomous choice of the individual”. “It is important to emphasize that no one should be forced to perform a self-test”, he stresses.
The text mentions that there is “a reasonable demand for rapid antigen testing as an alternative to self-testing and that is low cost”, which is allowed in several countries abroad, including policies of free public distribution, as in the United Kingdom. In addition, it is admitted that the pandemic situation has worsened in recent weeks.
“In Brazil, since the beginning of January 2022, the current scenario of covid-19, with the circulation of new variants of concern of the SARS-CoV-2 virus, in particular the Ômicron variant that has greater potential for transmissibility, has generated the increase in the demand for diagnosis and, consequently, a great demand for rapid tests in the health care network and the overload of health services”, admits the secretary. According to the text, the situation motivated the request to release the self-tests.
“With the citizen testing himself and, if positive, the identification of cases of covid-19 and the realization of self-isolation are increased. The main objective is to expand the population’s access to yet another test to identify infected 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 “. argues.
The text also admits that “it is necessary to expand the diagnosis to better serve the entire Brazilian population, which needs to have access to tests more quickly and effectively”. In another passage, it is said that “the self-test has excellent applicability in the pandemic context, as it allows the early isolation of positive cases and the breaking of the chain of transmission of covid-19”.
In the document, it is highlighted that the citizen who has a negative result “must be observed if there will be the appearance of symptoms to carry out new tests, as well as contact with cases of covid-19”. In the case of those who had contact with someone with a confirmed diagnosis or with persistence of suspicion, the recommendation is to have an RT-PCR exam.
“It is important to include in the package inserts the best time to perform the tests (depending on each manufacturer and S/E of the tests) which is generally from the 1st to the 7th day of the onset of symptoms and asymptomatic individuals should perform the test at from the 5th day of contact with a confirmed case of SARS-CoV-2. Individuals who test negative and have symptoms similar to COVID-19 should follow up with their physician, as negative results do not exclude an individual from SARS-CoV-2 infection.”
Anvisa determines suspension of two tests for covid-19
Anvisa determined on Tuesday, 25th, the collection and suspension of the commercialization, distribution, manufacture, import, advertising and application of the Isa Lab self-test and the meuDNA PCR-Lamp of self-collection by saliva, from the company Empreendimentos Pague Menos S/A. According to the agency, both are not registered with the agency and were sold irregularly.
“It is important to point out that, so far, there is no product approved by Anvisa as a self-test, that is, for use by lay users”, he highlighted. According to the agency, the determination took place after receiving complaints and an investigation, in which “the imminent health risk to the health of the population was evaluated and the restrictive measure aims to reduce the risk quickly”.
“The cases are still under evaluation and the infractions will be investigated in their own administrative processes”, he highlighted in a note.
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