Health must ask Anvisa to release a self-test for covid-19

The Ministry of Health must request the National Health Surveillance Agency (Anvisa) to release the use of self-tests to identify covid-19 in Brazil. The order is expected to be placed this week. To face the SARS-CoV-2 coronavirus pandemic, other countries already authorize the use of these tests, such as the United States.

At the moment, the sale of the self-test — which is an antigen test — is not allowed in Brazil. This means that an ordinary person cannot buy a test at a pharmacy, take their own sample and analyze the test result. If approved, the measure could facilitate, mainly, the screening of new cases of covid-19.

Brazil is considering authorizing the use of self-tests to identify cases of covid-19 (Image: Reproduction/Vesna Harni/Pixabay)

Risks of self-tests

On the other hand, some issues still need to be discussed. During the process of taking the exam, the patient who has no training in the health area can err in the interpretation of the result or even contaminate other people with a potentially positive sample of covid-19. Therefore, the question raises discussions about its validity.

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According to a note from Anvisa, released last Friday (7), “self-test products are for monitoring the conditions of a disease or detection of specific conditions, with the intention of helping the patient, but they are not conclusive for the diagnosis , and may be carried out by lay people”.

In other words, exams should only be an ally in the fight against covid-19, but they should not be the only means of diagnosis. After all, the accuracy of these tests is lower than that of RT-PCR, the exam considered the gold standard in the pandemic.

Self-test shows result in approximately 15 minutes (Image: Twenty20photos/Envato Elements)

Anvisa and the self-tests of covid

In the same note, Anvisa clarified that the current rules only allow “the registration of self-testing of infectious diseases subject to compulsory notification, such as covid-19, if there is a public health policy and action strategy established by the Ministry of Health”.

“For the adoption of an eventual public policy that allows the use of self-test for covid-19, it is essential to consider human factors and the usability of the product, product safety measures, limitations, warnings, care regarding storage, environmental conditions in the location that will be used, reading interval, among other aspects”, completes Anvisa.

Source: anvisa e G1

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