FDA authorizes first home test for COVID-19 and influenza

WASHINGTON (AP) — The Food and Drug Administration (FDA) approved Friday the first combination test for flu and COVID-19 that can be used at home, giving patients an easy way to to determine if a symptom such as a runny nose is caused by either disease.

The test, called the Lucira COVID-19 & Flu Home Test, can be purchased without a prescription.

It uses self-collected nasal swab samples and provides results in about 30 minutes, the agency said.

While home tests for COVID-19 are readily available, this is the first home test for influenza A and B, commonly known as the flu.

The new test that detects the COVID-19 and flu virus. Lucira Health

The test obtained an emergency use authorization, a type of authorization that allows to have these medical facilities faster in the event of a public health emergency.

Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, called the clearance "

in providing greater consumer access to diagnostic tests that can be performed entirely at home."

The agency said the test is for people "

" and said it can be used in children as young as 2 years old, with the help of adults taking the samples.

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It recommends that test results be released to health care providers and warns that there is a risk of false positives and negatives.

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“Individuals who test negative and continue to have symptoms such as fever, cough, or shortness of breath may still have a respiratory infection and should seek follow-up care with their medical 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.