The Food and Drug Administration has approved the first combination test for the flu and COVID-19 that can be used at home, giving consumers an easy way to tell if a runny nose is caused by either disease
Feb 24, 2023 9:30pm ET
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WASHINGTON – The Food and Drug Administration on Friday approved the first combination test for flu and C OVID-19 that can be used at home, giving consumers an easy way to tell if a runny nose is caused by either disease.
The Lucira COVID-19 & Flu Home Test, which can be purchased without a prescription, uses home-collected nasal swab samples and provides 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 clearance, facilitating the availability of “medical countermeasures” in public health emergencies.
Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, called the approval “an important milestone in providing consumers with greater access to diagnostic tests that can be performed entirely at home.”
The agency said the test is for people “with signs and symptoms consistent with a respiratory infection” and said it could be used in children as young as 2 years old, with adults taking the samples.
It recommends that tests be reported to healthcare providers and warns there is a risk of false positives and negatives. “Individuals who test negative and continue to have symptoms of fever, cough and/or shortness of breath may still have a respiratory infection and should contact their doctor,” the agency said.
Citing the impact of COVID and RSV, another respiratory infection, the FDA said it “recognizes the benefits that home testing can offer” and will work to increase the number of tests available.