FDA authorizes first over the counter at-home COVID-19, influenza test
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The FDA has issued emergency use authorization for the Lucira COVID-19 & Flu Test, the first over the counter at-home diagnostic test that can differentiate and detect influenza A and B, and SARS-CoV-2, the FDA announced in a press release.
The test is a single-use, at-home test kit that can be purchased without a prescription and provides results from self-collected nasal swab samples in about 30 minutes, the release said.
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The authorization is supported by positive efficacy data in which 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, according to the release.
Samples may be self-collected by patients aged 14 years and older or collected by an adult for patients aged 2 years or older, according to the release.
“Today’s authorization of the first OTC test that can detect Influenza A and B, along with SARS-CoV-2, is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in the release. “The FDA strongly supports innovation in test development, and we are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs.”
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