The Food and Drug Administration has approved the first combination test for flu and COVID-19 that can be used at home, making it easy for consumers to determine if a runny nose is caused by either disease
WASHINGTON — 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 is available over the counter, uses self-administered nasal swabs and provides results in about 30 minutes, the agency said.
While 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 approved for emergency use, facilitating the availability of “medical countermeasures” during public health emergencies.
Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, called the authorization “an important milestone in increasing consumer access to diagnostic tests that can be performed entirely at home.”
The agency said the test is for individuals “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 collecting the samples.
It recommends that tests be reported to healthcare providers and warns 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 from their healthcare provider,” the agency said.
Citing the impact of COVID and RSV, another respiratory infection, the FDA said it “recognizes the benefits home testing can provide” and would work to increase the number of tests available.