The National Health Surveillance Agency (Anvisa) authorized the use of Covid-19 self-tests in Brazil this Friday (28), after analyzing the request and sending additional information by the Ministry of Health.
The approval allows the sale of self-tests by pharmacies and health establishments licensed to sell medical devices after the exams are registered with Anvisa.
In an interview with CNN, the general manager of Technology in Health Products at Anvisa, Leandro Rodrigues Pereira, explained that the result of the self-test is not valid for travel and tickets to events.
“The self-test does not generate a report. You will take the test on the device and it will indicate the situation, similar to what we have with pregnancy tests sold in the pharmacy. You do not have a document to present to a health authority, in the case of travel, or even to present for admission purposes”, he said.
The expert adds that the self-test should be used as a screening methodology and that patients who test positive should undergo confirmatory examination in health facilities or laboratories.
“The self-test is performed with samples with nasal or saliva collection and, from there, the patient is able to have a result that is considered screening. It does not serve as a confirmatory test. If the patient tests positive, the orientation of the public policy established by the Ministry of Health is for that citizen to go to the health service to be able to have a confirmatory test”, he said.
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The commercialization of self-tests in the country depends on the registration of the products with Anvisa, which must be requested by the manufacturing companies.
According to Pereira, the analysis of requests will be a priority for the agency. “Our expectation is that on Monday, we will have protocols and registration requests. Every request will be dealt with in priority by the agency. We imagine that in the month of February we will have products approved and on the market”, he said.
Check out guidelines from the Ministry of Health in the face of positive diagnosis of Covid-19
Reference: CNN Brasil
