U.S. FDA authorizes sale of first home COVID/flu combo test outside of emergency use

FDA authorizes sale of first home COVID/flu combo test outside of emergency use The test joins other over-the-counter COVID-19/flu tests already available under emergency use authorization. CIDRAP

As the country heads into the respiratory illness season, the US Food and Drug Administration (FDA) announced yesterday its marketing authorization of the first over-the-counter (OTC) rapid-antigen COVID-19/flu combination test outside of emergency use authorization.

The Healgen Rapid Check COVID-19/Flu A&B Antigen Test takes 15 minutes to detect proteins from both COVID-19 and influenza A and B in nasal swabs. It joins other OTC COVID-19/flu tests already available under emergency use authorization. The test is designed for use by people aged 14 years or older collecting and testing their own sample or those 2 and older with adult assistance.

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