Federal regulators authorized the first over-the-counter, at-home test Friday that can detect both the flu and COVID-19.
The U.S. Food and Drug Administration issued an emergency use authorization for the Lucira COVID and flu test, which provides test results from a nasal swab in roughly 30 minutes, according to the FDA.
The test is similar to those for COVID and can be self-administered by anyone ages 14 and older or administered by an adult for children between ages 2 and 13.
According to the FDA, the Lucira test gave correct results for roughly 99 percent of both negative influenza A and B samples, 100 percent of negative COVID samples, 90 percent of positive influenza A samples and 88 percent of positive COVID samples.
All trial samples were taken from people with symptoms, FDA officials said.
“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,” said Dr. Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health.
The authorization requires Lucira to continue collecting test samples to confirm its ability to correctly report positive and negative influenza B samples, as there are not enough cases of that flu strain for a clinical study.
The FDA approved a separate non-prescription COVID and flu test, manufactured by Labcorp, last spring.
That test allowed users to send a nasal swab to Labcorp’s laboratories for analysis, but did not provide at-home results.