The U.S. Food and Drug Administration approved Lucira under an emergency use authorization (EUA) on Friday.
“Today’s authorization of the first OTC [over-the-counter] 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,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in an agency news release. “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.”
Those who have symptoms of a respiratory tract infection can collect a sample from their noses using a nasal swab and then swirling that in a vial of test solution. After 30 minutes, the test unit will show whether someone is positive for COVID or flu.
The test will be sold without a prescription. It can be used by anyone 14 and up or by an adult on children ages 2 and older.
The FDA notes that Lucira was accurate in 99.3% of negative samples and 90.1% of positive samples for influenza A and 100% of negative and 88.3% of positive COVID samples. It was 99.9% accurate for negative influenza B samples, but there was not enough circulating virus to determine how accurate it was for positive samples.
The study did confirm that the test can identify Influenza B in contrived specimens, according to the FDA. The EUA requires Lucira to continue collecting samples to study the test’s ability to detect Influenza B in real-world settings.
People who have positive test results should share this information with their doctors, the FDA said. They should also take precautions to avoid spreading the virus and seek follow-up care with a physician.
Negative results for SARS-CoV-2 and influenza B, if it’s necessary for patient management, should be confirmed with an authorized molecular test performed in an approved laboratory, the FDA said.
People who still have fever, cough and/or shortness of breath even after testing negative may still have a respiratory infection, the FDA noted. They should seek follow-up care with their healthcare provider.
The impact of flu, COVID and RSV have underscored the importance of having tests for various respiratory viruses, the FDA said. The agency plans to continue increasing the number of easy-to-use, at-home tests available to the public.
Lucira Health, the company that manufactures the test, has filed for bankruptcy, so it’s not clear what its manufacturing capacity is at this point or what the possible cost for the tests might be, the New York Times reported.
The company was “very excited” about the authorization, said Erik Engelson, Lucira’s chief executive said in a statement on Friday, theTimes reported.
“I can’t thank our employees and partners enough for seeing this through, and of course, for the FDA’s recognition,” Engelson said.
Lucira said earlier it had expected the EUA in August before flu season began, but the FDA process “became protracted,” the Times reported.
The U.S. Centers for Disease Control and Prevention has more on COVID-19 testing.
SOURCE: U.S. Food and Drug Administration, news release, Feb. 24, 2023; New York Times