First combination home test for flu and covid approved by the FDA


The Food and Drug Administration on Friday authorized the first all-at-home combination test for the flu and coronavirus, giving consumers an easy way to determine which pathogen may be causing their respiratory illness.

The agency granted emergency use authorization for the Lucira Covid-19 & Flu Test, which provides results in about 30 minutes based on samples collected with a nasal swab. The test could be especially useful in winters, like this season, when the flu, covid-19 and RSV caused a range of miserable symptoms.

For now, no home test for flu is available. Instead, people are tested at a doctor’s office or other locations, such as emergency rooms. And other combination flu-coronavirus tests typically require samples to be sent to a lab for analysis.

The FDA said the new test is for people with symptoms of a respiratory infection, including covid-19, the disease caused by the coronavirus. The Lucira test can be purchased without a prescription by anyone over the age of 14.

Jeanne Marrazzo, director of the infectious disease division at the University of Alabama at Birmingham, welcomed the permission, calling a home combination test “so late.”

“Assuming the test performs well, it will really help guide the appropriate use of therapy and ideally prompt healthcare providers to prescribe the medications that are indicated,” such as Paxlovid for covid-19 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 an important milestone in increasing consumer access to diagnostic tests that can be performed entirely at home.”

The test is the latest example of how the pandemic has spurred FDA and industry efforts to increase home testing. Shuren said the agency is “eager to continue to improve access to at-home infectious disease testing to best support public health.”

In its statement, the FDA 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 of infection control at Tufts Medical Center in Boston, said so broadly, the test is “a good thing” because it provides important information for diagnosis and treatment at an earlier stage.

But she said she was concerned about the FDA’s suggestion that all patients who take the test call their doctors with the results. “Not everyone needs to be treated for the flu,” she said, adding that a deluge of phone calls could overload the health care system.

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

She also noted that the test may not be necessary at this point. “The flu is essentially gone now,” Doron said. But there she warned a second wave of flu last spring made her hesitate to predict that the flu will be over this 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 to antibiotic therapy.

“The hope is that GPs will say, ‘Oh, I don’t need to take an antibiotic,’” Marrazzo said.

William Schaffner, professor of infectious diseases at Vanderbilt University Medical Center in Nashville, called the permit “very cool,” adding that “anything we can do to raise awareness among people if they have any of these diseases, especially if they’re at high risk, and get care right away, a good thing.”

He said it was important that the price be set at a level that would allow fair access to the test.






Leave a Reply

Your email address will not be published. Required fields are marked *