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

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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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