FDA authorizes first over-the-counter home test that detects influenza and COVID-19

The U.S. Food and Drug Administration issued an emergency use authorization on Friday. for the first over-the-counter home diagnostic test that can differentiate and detect influenza and COVID-19.

The test, called the Lucira COVID-19 & Flu Test, is a single-use home testing kit for people who show signs and symptoms of a respiratory tract infection.

The test will require people to provide a nasal swab sample by taking a swab sample in a vial to be placed in a test facility similar to home COVID tests. Results will appear in about 30 minutes, according to the FDA.

“Today’s authorization of the first over-the-counter test that can detect influenza A and B, as well as SARS-CoV-2, is a major milestone in ensuring greater consumer access to diagnostic tests that can be performed entirely at home,” said Jeff Shuren, MD. Sciences. , JD, director of the FDA’s Center for Devices and Radiological Health. “The FDA strongly supports innovation in test development, and we are committed to continuing to expand access to home testing for infectious diseases to best serve public health needs. We remain committed to working with test developers to support our common goal of providing more accurate and reliable tests to the Americans who need them.”

The FDA said the Lucira COVID-19 & Flu Test was able to correctly identify 99.3% negative and 90.1% positive influenza A samples, 100% negative and 88.3% positive COVID-19 samples, and 99.9% negative samples influenza B. samples.

“Because there are currently not enough influenza B cases circulating to be included in a clinical trial, the review confirmed that the test can identify the virus in artificial samples, and the EUA requires Lucira to continue to collect samples to study the test’s ability to detect influenza. B under real-world conditions,” the FDA said.

The Lucira test for COVID-19 and influenza will be available without a prescription.

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