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Brazil approves use and marketing of COVID-19 self-tests

29 January 2022 14:46

BRASILIA. KAZINFORM - The board of directors at Brazil’s national drug authority Anvisa today (Jan. 28) unanimously approved the use and sale of self-test kits for COVID-19 in the country, Agencia Brasil reports.

The move comes after the Health Ministry provided the data requested by Anvisa on January 19 regarding the inclusion of self-test kits as part of the country’s testing policies.

The agency is now expected to publish a resolution so that the companies interested in selling the kits at Brazilian drugstores may submit the products for registration and demonstrate they have met the requirements established.

This means that the self-test kits should not be immediately available to the public, as producers and importers must be individually licensed by Anvisa following assessment.

Requirements

Among the criteria established is that the kits should include clear and accurate information advising the public at large on how to appropriately collect the sample and conduct the test, Anvisa Director Cristiane Rose Jourdan Gomes pointed out.

The kits must also have at least 90 percent sensitivity to the coronavirus and 97 percent specificity detecting the virus, she added.

Monitoring

The self-test kits were approved after ministry officials pledged to add a section on the topic in Brazil’s national plan to expand COVID-19 testing. To keep track of positive cases, test producers will be required to build a dedicated platform accessible through QR codes.

Yesterday (27), Health Minister Marcelo Queiroga stated that the self-tests will not be made available at Brazil’s Unified Network of Public Hospitals (SUS). The idea, he declared, is to have them sold at drugstores, «for whoever is interested in purchasing them.»


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