The United States has approved the over-the-counter sale of a rapid test for COVID-19 » Medvestnik

Acon Laboratories’ Flowflex at-home rapid COVID-19 test is the first to receive full retail over-the-counter approval from the FDA. The test will be available on US store shelves in 2024.

The U.S. Food and Drug Administration (FDA) has issued the first full over-the-counter (OTC) approval for Acon Laboratories’ COVID-19 at-home test. It also became the first test to detect the SARS-CoV-2 antigen, first indicated for use in patients under the age of 18 years, the Pharmaceutical Bulletin reported, citing the website of the American regulator.

The rapid test, branded Flowflex, correctly identified 89.8% of positive control samples and 99.3% of negative control samples, according to a study reviewed by the FDA. The test is recommended within six days of detecting symptoms of COVID-19. The antigen test must be performed twice within three days, at least 48 hours apart. The press release notes that if the test shows a false negative result the first time, it is more likely to detect COVID-19 during the second test.

Acon Laboratories’ product received emergency use approval from the FDA back in 2021. In a statement, the manufacturer of the rapid test said Flowflex will begin sales in the United States in 2024.

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