FDA Authorizes Flu-COVID Test for Home Use

March 1, 2023 by Dan McCue
FDA Authorizes Flu-COVID Test for Home Use
Boxes of flu vaccine. (Photo by Dan McCue)

WASHINGTON — The Food and Drug Administration has approved the first combination test for flu and COVID-19 that can be used at home.

The test from Lucira Health, which can be purchased without a prescription, can detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID, the FDA said in a press release.

Like the at-home COVID tests that have become common in the wake of the pandemic, the combination test will also use self-collected nasal swab samples. 

Results will then be ready in 30 minutes or less, the agency said.

The test was granted an emergency use authorization on Feb. 28, which facilitates the availability of “medical countermeasures” during public health emergencies.

Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said authorization of the test “is a major milestone in bringing greater 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 tract infection” and said it can be used on children as young as 2, with adults collecting the samples.

It recommends that tests be reported to health care 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 health care provider,” the agency said.

It’s unknown when the test will actually be available to consumers. Many private insurers and Medicare have paid for at-home COVID tests during the pandemic. 

It is also unclear how the end of the COVID public health emergency in May will affect consumers’ access to the new test.

Dan can be reached at [email protected] and at https://twitter.com/DanMcCue

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