FDA approves the first combination at-home test for flu and COVID

(Photo: Photocreo Bednarek/Adobe Stock)

The Food and Drug Administration issued an emergency use authorization for the first combination test for flu and COVID on Friday. The over-the-counter at-home diagnostic test can differentiate and detect the flu and COVID-19, giving consumers an easy way to get a quick diagnosis for a runny nose. 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 test “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.”

When available, the Lucira test can be purchased without a prescription and performed completely at-home using nasal swab samples self-collected by individuals ages 14 years or older or collected by an adult for individuals 2 years of age or older. 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.