Anvisa receives first registration request for covid-19 self-test

Anvisa releases two more covid-19 self-tests

Brazil already has six self-tests for covid-19 approved by the National Surveillance Agency (Anvisa), the two most recent were released this Wednesday (2) by the agency. To obtain the registration, the products were evaluated for safety, performance and compliance with the legal requirements required for self-tests.Anvisa releases two more covid-19 self-tests

“One of Anvisa’s main points of attention for analyzing self-tests is usability, which includes guidelines for use and instructions in simple language that allow the lay person to make the correct use of the product,” explained the agency.


One of the products is the “Autotest COVID-19 Ag” registered by the company Biosul Produtos Diagnósticos. The exam is manufactured by Hangzhou Alltest Biotech of China. The test uses the swab and will have a commercial presentation with one product per package.

The second test is the “SGTi-flex COVID-19 Ag – SELF TEST” registered by the company Kovalent do Brasil. The product is manufactured by Sugentech of South Korea. The exam also uses the swab nose, but will have a more varied commercial presentation in versions with one, two or five tests per pack.

self test

The self-test is the product that allows the person to perform all the steps of the exam, from sample collection to the interpretation of the result, without the need for professional help. To do so, you must carefully follow the information in the instructions for use, which have simple language and illustrative step-by-step figures. According to Anvisa, regardless of the result measured, the use of masks, vaccination and physical distance must be maintained as they reduce the chances of transmission of the new coronavirus.

THE full list of the approved self-tests will be updated periodically and is available on Anvisa’s electronic panel.

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