The FDA has authorized the first over-the-counter (OTC) home test to detect both influenza A and B and COVID-19, the agency announced Friday.
The Lucira COVID-19 & Flu Test is a single-use at-home test kit that provides results in about 30 minutes. The test is designed for those with symptoms of a respiratory tract infection. It can be purchased without a prescription and performed completely at-home using nasal swab samples self-collected by anyone 14 or older, or swabs collected by an adult for children ages 2 and older.
“Today’s authorization … is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a press 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. 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,” Shuren continued.
In individuals with symptoms, the Lucira COVID-19 & Flu 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, the FDA said. For influenza B, there are not enough circulating cases to include in a clinical trial, so the emergency use authorization (EUA) “requires Lucira to continue to collect samples to study the test’s ability to detect influenza B in real-world settings,” according to the FDA.
As with all rapid diagnostic tests, there is a risk of false positive and false negative results, the FDA warned, adding that those who test positive for either flu or COVID-19 “should take appropriate precautions to avoid spreading the virus and should seek follow-up care with their physician or healthcare provider, as additional testing may be necessary.”
Negative results for either illness should be confirmed with a molecular test if it’s necessary for patient management. “Individuals who test negative and continue to experience symptoms of fever, cough and/or shortness of breath may still have a respiratory infection and should seek follow-up care with their healthcare provider,” the agency said.
The EUA appears to have come a little too late for Lucira Health, the test’s manufacturer, which announced on Wednesday that it had filed for Chapter 11 bankruptcy protection.
“The company anticipated an EUA for an OTC indication on the COVID-19 and flu test in August 2022, [but] the FDA’s approval process became protracted, resulting in high expenditures without new revenue from the combined test kit during the 2022-2023 flu season. As such, the company’s operations were significantly impacted, leading to the Chapter 11 filing and sale process,” Lucira Health said in the press release.
“The company expects to continue operations during the Chapter 11 process and seeks to complete an expedited sale process with bankruptcy court approval,” the company added. “Lucira intends to use available cash on hand to fund post-petition operations and costs in the ordinary course.”
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