The board of the National Health Surveillance Agency (Anvisa) released, this Friday (28), the possibility of marketing covid-19 tests that can be applied by the general population, the so-called covid-19 antigen research self-tests. 19. They should be used as screening to allow for early isolation and breaking the chain of transmission of the virus, but diagnosis depends on confirmation at a health facility. With the difficulties to carry out the exams in the testing centers, due to the high demand and the illness of the professionals themselves, the expectation is that the self-test will collaborate to help the citizen to identify if he is infected.
For the Secretary of Health of Pernambuco, André Longo, the authorization of the use of self-tests by Anvisa is an advance and can help in the fight against covid-19. Last Thursday (27), he even spoke about the matter at a press conference. “It is necessary to establish a rule so that there is access to this type of testing. This is how the demand from European countries and the United States was met. This will be important for us to overcome especially these next 30 days (period in which the peak of the ômicron in the State)”, highlighted Longo.
This Friday (28), after the release of Anvisa, the secretary told the JC that the self-test is able to speed up testing to help break the chain of transmission of the coronavirus. However, he made some considerations. “Self-testing helps, but it will not have a greater impact without the federal government, as other countries have done, create a more robust and comprehensive public policy for purchase, distribution, education and training for use, in addition to monitoring the results for health surveillance. with these self-tests”, commented Longo.
For covid-19, only products approved for the purpose of antigen research can be used by the general population. They may be marketed in the country, after registration by Anvisa, which has undertaken to analyze requests for registration of self-tests with priority. The agency stresses that rapid antigen tests approved for professional use cannot be used as self-tests by the general population. These products may differ in performance, the type of sample to be used (which may require professional training), and instructions for use. That is, they may pose a risk to the reliability of the result if used by unqualified persons.
According to Anvisa, people will be able to buy self-tests for researching the antigen of covid-19 in pharmacies and drugstores that are regularized with the health surveillance for the sale of this type of product.
“Self-tests may also be marketed by health establishments that are licensed by the health surveillance agency for (direct-to-consumer) retail trade of medical items. For example, establishments that sell dressings, compression stockings and orthoses, among others. the sale of self-tests on an e-commerce site”, says Anvisa in a question-and-answer guide.
With approval, the agency will publish a resolution with the necessary requirements for companies interested in selling self-tests in pharmacies to request product registration. That is, these products are not immediately available to the final public. To be marketed in pharmacies, each product must also be individually approved by Anvisa, after analysis of extensive documentation. Among the requirements for approval of each product, there is the need for self-tests to present information, with clear and precise language, in order to guide people on how to properly collect biological material and perform the exam. Another detail is that the products must have a sensitivity of 80% to the coronavirus and a specificity of at least 97% in the detection of the virus.
Also according to the agency, the self-test does not provide a diagnosis. It serves as a screening to guide the user about the risk of transmission of the virus and the measures that can be taken. Therefore, only tests carried out by health professionals, who present official reports regarding the identification or not of the antigen or genetic material of the virus in the sample, are accepted as proof for those who wish to travel. For the same reason, in events that require the presentation of covid-19 exams, the self-test is not valid.