First combination home test for flu and covid cleared by FDA

The Food and Drug Administration on Friday authorized the first combination test for the flu and the coronavirus that is fully performed at home, giving consumers a convenient way to determine which pathogen may be causing their respiratory illnesses.

The agency granted emergency use authorization to the Lucira Covid-19 & Flu Test, which provides results in about 30 minutes from samples collected by a nasal swab. The test could be particularly helpful in winters, such as this season, in which the flu, covid-19 and RSV jockeyed to inflict an array of miserable symptoms.

Before now, no at-home test for flu has been available. Instead, people are tested at a physicians’ office or at other sites, such as urgent care clinics. And other combination flu-coronavirus tests typically require that samples be sent to a lab for analysis.

The FDA said the new test is for people with symptoms of a respiratory tract infection, including covid, the disease caused by the coronavirus. The Lucira test can be bought without a prescription by anyone at least 14 years old.

Jeanne Marrazzo, director of the division of infectious diseases at the University of Alabama at Birmingham, welcomed the authorization, calling an at-home combination test “so overdue.”

“Assuming the test’s performance is good, it will really help direct the appropriate use of therapy and ideally prompt providers to prescribe the medicines that are indicated,” such as Paxlovid for covid and Tamiflu for flu, Marrazzo said.

Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement that the authorization “is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home.”

The test is the latest example of how the pandemic has driven efforts by the FDA and industry to provide more home tests. Shuren said the agency is “eager to continue advancing greater access to at-home infectious disease testing to best support public health needs.”

The FDA, in its statement, urged people taking the test to report the results to their health-care providers for public health reporting and to receive appropriate medical care.

Shira I. Doron, chief infection control officer for Tufts Medical Center in Boston, said that overall, the test is “a good thing” because it will provide important information at an earlier stage for diagnosis and treatment.

But she said she was concerned about the FDA’s suggestion that all patients taking the test call their doctors with results. “Not everybody needs to be treated for flu,” she said, adding that a flood of calls could overburden the health-care system.

“I would like to see more public education on who should have the tests and who should call their doctor,” Doron said.

She also noted that the test might not be needed at this moment. “Flu is essentially gone right now,” Doron said. But she cautioned that a second wave of flu last spring made her hesitant to predict that flu is gone for the year.

Marrazzo, of the University of Alabama, said she hoped the test would reduce a major problem: the inappropriate treatment of respiratory viruses with antibiotics, which don’t work on viruses and can cause resistance against antibiotic therapy.

“The hope is that primary care physicians will say, ‘Oh, I don’t need to use an antibiotic,’ " Marrazzo said.

William Schaffner, a professor of infectious diseases at Vanderbilt University Medical Center in Nashville, called the authorization “very cool,” adding that “anything we can do to make people more aware if they have one of these illnesses, especially if they are at high risk, and to get care right away is a good thing.”

He said it was important the price be set at a level allowing for equitable access to the test.