The U.S. Food and Drug Administration has issued an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test is a single-use at-home test kit that provides results from self-collected nasal swab samples in roughly 30 minutes.
“The 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,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “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. We remain committed to working with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them.”
The Lucira COVID-19 & Flu Home Test is a single-use test for individuals with signs and symptoms consistent with a respiratory tract infection, including COVID-19. The test can be purchased without a prescription and performed completely at-home using nasal swab samples self-collected by individuals 14 years or older or collected by an adult for individuals age two or older.
The test works by swirling the sample swab in a vial that is placed in the test unit. In 30 minutes or less, the test unit will display the results that show whether a person is positive or negative for each of the following: Influenza A, Influenza B and COVID-19. Individuals should report all results obtained to their healthcare provider for public health reporting and to receive appropriate medical care.
In individuals with symptoms, the Lucira COVID-19 & Flu Home 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. Since there are currently not enough cases of Influenza B circulating to include in a clinical study, validation confirmed that the test can identify the virus in contrived specimens, and the EUA requires Lucira to continue to collect samples to study the test’s ability to detect Influenza B in real-world settings.
