FDA authorizes at-home combination flu-COVID test

WASHINGTON — The Food and Drug Administration on Friday approved the first combined test for the flu and COVID-19 that can be used at home, giving consumers an easy way to identify Determine if a runny nose is caused by either disease.

The agency says the Lucira COVID-19 & Flu Home test, which can be purchased without a prescription, uses self-collected nasal swabs and gives results in about 30 minutes.

While at-home COVID tests are available, this is the first home test for influenza A and B, commonly known as the flu. The trial was licensed for emergency use, facilitating “medical countermeasures” during public health emergencies.

Jeff Shuren, director of the FDA’s Center for Radiological Health and Devices, called the authorization “an important milestone in giving consumers greater access to diagnostic tests that can be performed.” now completely at home.”

The agency says the test is intended for individuals who “have signs and symptoms consistent with a respiratory infection” and says it can be used in children as young as 2 years old, with adults taking the sample. .

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 have symptoms of fever, cough and difficulty breathing may still have a respiratory infection and should seek follow-up care with their home,” the agency said. provide their health care”.

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. .