FDA OKs first OTC at-home test to detect COVID-19 and flu

FDA issued an EUA on February 24, 2023, for the first at-home OTC diagnostic test that can differentiate and detect influenza A and B and the SARS-CoV-2 virus.

The Lucira COVID-19 & Flu Home Test is a single-use test kit that uses self-collected nasal swab samples to provide results in about 30 minutes.

“Today’s authorization of the first OTC test that can detect [i]nfluenza 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,” said Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, in a press statement. “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.”

FDA noted that in individuals with symptoms, the new 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.

With insufficient cases of influenza B circulating to include in a clinical test, validation confirmed the test can identify the virus in contrived specimens. FDA’s EUA for the test mandates that Lucira continue to collect samples to assess the test’s ability to identify influenza B in real-world settings.

FDA notes that as with all rapid diagnostic tests, there is a risk of false positive and false negative results. They said that individuals who test positive for either flu or COVID-19 should take appropriate precautions to avoid spreading the virus and should seek follow-up care with their physician or health care provider as additional testing may be necessary.