FDA approves combination flu-COVID test for home use
Covid-19 at-home tests for sale at a CVS Pharmacy store in New York, US, on Friday, Nov. 11, 2022. (Photographer: Nora Savosnick/Bloomberg via Getty Images
The Food and Drug Administration on Friday approved the first combination test for flu and COVID-19 that can be used at home, giving consumers an easy way to determine if a runny nose is caused by either disease.
The Lucira COVID-19 & Flu Home test, which can be purchased without a prescription, uses self-collected nasal swab samples and delivers results in about 30 minutes, the agency said.
While at-home COVID tests are readily available, this is the first home test for influenza A and B, commonly known as the flu. The test was granted an emergency use authorization, which facilitates the availability of "medical countermeasures" during public health emergencies.
READ MORE: First-ever RSV vaccine could be approved by August 2023, pending FDA review
Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, called the authorization "a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home."
Tri-demic concerns: COVID-19, RSV & the flu | LiveNOW from FOX
Peter Chin-Hong, MD, a professor in the UCSF Health Division of Infectious Diseases, speaks with LiveNOW's Andrew Craft about tri-demic concerns regarding COVID-19, RSV and the flu. Dr. Chin-Hong also speaks about the shortage of children's medications across the U.S., and what parents can do if they are in need of medicine that they cannot find.
The agency said the test is for individuals "with signs and symptoms consistent with a respiratory tract infection" and said it can be used on children as young as 2, with adults collecting the samples.
READ MORE: President Biden to end country's COVID-19 emergencies on May 11
It recommends that tests be reported to healthcare providers and cautions that there is a risk of false positive and negative results. "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.
Citing the impact of COVID and RSV, another respiratory infection, the FDA said it "recognizes the benefits that home testing can provide" and would work to increase the number of tests available.