The FDA has approved the first home self-test to detect flu and COVID-19 at the same time

The US Food and Drug Administration (FDA) on Friday cleared first combined test for the reproach and the COVID-19 which is performed entirely at home, providing people with a suitable option to determine which pathogen may be causing their respiratory illnesses.

The agency emergency use authorization granted to Lucira Covid-19 & Flu Test, which provides results in approximately 30 minutes from samples collected by a nasal hyssop. The test could be particularly useful in winter, when influenza, COVID-19 and respiratory syncytial virus (RSV) compete to cause strong symptoms.

Until now, no home flu tests were available in the United States. So until this self-test was allowed, people had to be tested in a doctor’s office or other places, such as urgent care clinics. And other combined flu and coronavirus tests usually require samples to be sent to a lab for testing.

The FDA said the new test is for people with symptoms of a respiratory tract 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 Division of Infectious Diseases at University of Alabama at Birminghamenthusiastically welcomed the clearance, saying, “Assuming the trial goes well, this will really help guide the appropriate use of treatment and, ideally, inspire healthcare providers to prescribe the right drugs.” , such as Paxlovid for COVID -19 and Tamiflu for the flu, Marrazzo said.

Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement that the clearance “is an important step in providing greater consumer access to diagnostic tests that can be performed entirely at home. “.

The test is the latest example of how the pandemic has spurred efforts by the FDA and industry to provide more home testing. Shuren said the agency “looks forward to continuing to promote greater access to home-based infectious disease testing to meet public health needs.”

In its statement, the FDA urged people who get tested to report results health workers to receive adequate medical care.

Shira I. Doron, Director of Infection Control at Tufts Medical Center in Bostonnoted that overall the test is a “good thing” as it will provide important information at an earlier stage for diagnosis and treatment.

However, he expressed concern about the FDA’s suggestion that all patients who get tested call their doctor with the results. “Not everyone needs flu treatment,” he said, adding that a deluge of calls could overwhelm the health care system. “I would like to see more public education on who should get tested and who should call their doctor,” Doron said.

He also noted that the test may not be needed at this time in the United States. “The flu is basically gone at this point,” Doron said. She warned, however, that a second wave of flu last spring made her hesitant to predict the flu would be gone for the rest of the year.

Marrazzo, of the University of Alabama, said he hoped the test would narrow down a major problem: inadequate treatment of respiratory viruses con antibiotics, which do not work for viruses and can cause resistance to antibiotic therapy. “The hope is that primary care doctors will say, ‘Oh, I don’t need to use an antibiotic,'” Marrazzo said.

William Schaffner, professor of infectious diseases at Vanderbilt University Medical Center in NashvilleHe called the clearance “very good” and added that “anything we can do to make people aware if they have any of these diseases, especially if they are at high risk and receiving care immediately , is a good thing”. .

Furthermore, he noted that it was important that the price be set at a level that would allow the equal access to the test.

* By Laurie McGinley, The Washington Post periodist

Continue reading: