US FDA Issues Emergency Use Authorization for First At-Home COVID and Flu Combo Test Kit

March 3, 2023

After a winter hallmarked by coexiting waves of COVID-19, seasonal flu, and RSV, the US Food and Drug Administration has given the Lucira COVID and Flu Home Test emergency use authorization (EUA). The at-home test kit is the first of its kind approved by the agency, simultaneously testing for COVID-19 and the flu in patients experiencing respiratory symptoms characteristic of either disease.

According to Emily Kimber, “The decision is supported by results that showed the test correctly identified 99.3% of negative and 90.1% of positive influenza A samples, 100% of negative and 88.3% of positive COVID-19 samples and 99.9% of negative influenza B samples in symptomatic individuals. Since there are currently not enough cases of influenza B circulating to include in a clinical study, the EUA requires Lucira Health to continue to collect samples to study the test’s ability to detect the virus in real-world settings.”

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