The Lucira test will be sold over-the-counter and it can detect both Influenza A and Influenza B, as well as the SARS-CoV-2 virus - the virus that causes COVID-19, FDA officials announced Friday in a news release.
The Food and Drug Administration has issued an emergency use authorization for the first at-home test that can be used to detect both the flu and COVID-19. Image courtesy of Lucira Health
The announcement marks a breakthrough as the first at-home test for flu, the Washington Post reported. Testing for the flu previously required a visit to a doctor's office or urgent care clinics.
"Today's authorization ... is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home," said Jeff Shuren, 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," he said.
The single-use test works by using a nasal swap that is placed in the test unit, which provides results within 30 minutes
The test correctly identified 99.3% of samples negative for Influenza A while correctly identifying 90.1% of samples positive for the virus in clinical studies.
The test also properly identified 99.9% of samples negative for Influenza B in a small sample size.
The Lucira test, meanwhile, correctly identified 100% of tests negative for COVID-19 and 88.3% of positive COVID-19 samples, according to the FDA.
Lucira Health CEO Erik Engelson told USA Today that the company will announce the cost for the test at a later date.
"This is a major milestone for Lucira Health and at-home diagnostics, and I can't thank our employees and partners enough for seeing this through, and of course, for the FDA's recognition," he said.
The company currently also sells a molecular COVID-19 test for $34.99.
The FDA's suggestion that anyone who tests positive for the flu with the Lucira should test call their doctor's office was disputed by Shira Doron, chief infection control officer for Tufts Medical Center in Boston.
"Not everybody needs to be treated for flu," she told the Post. "I would like to see more public education on who should have the tests and who should call their doctor."