FDA authorizes first home COVID and flu test, but you can’t buy one yet

The U.S. Food and Drug Administration on Friday announced approval of the first over-the-counter home test that can tell you if you have the virus that causes COVID-19 or the flu, all with a single nasal swab.

The Lucira COVID-19 & Flu home test is a nasal swab test that uses nucleic acid amplification, and it is intended for people aged 2 years and older with symptoms of a respiratory virus. Within 30 minutes, the test can tell users whether they are positive or negative for COVID-19, influenza A, and influenza B, the FDA said in a press release. Influenza A and B strains are responsible for flu season each year.

However, just days before the FDA announced its emergency authorization of the dual COVID-19 and flu home test, the test’s maker, Lucira Health, filed for bankruptcy. In a Feb. 22 statement, Lucira called the FDA approval process “prolonged,” adding that she expected the FDA to greenlight her flu and COVID test. -19 available over-the-counter by August 2022, before the flu and COVID-19. burden was high, and a test capable of detecting both would be in greater demand. Lucira’s bankruptcy has already been reported by STAT News and other outlets.

A Lucira Health customer representative told CNET that people in the United States cannot purchase an over-the-counter flu and COVID-19 test at this time, as the company is still awaiting information from corporate headquarters on when. availability, how much it will cost, and whether Lucira will be purchased by another company before it dissolves. Lucira sells other tests, including a medical-use COVID-19 and flu test that requires a prescription, and a home COVID-19 molecular test.

Still, even with the bumpy road Lucira is currently on, the authorization of an over-the-counter test that can detect both COVID-19 and the flu is a breakthrough for home health care, especially during the winter months. fall and winter seasons when both viruses are expected. disseminate widely with generally similar symptoms, such as cough, sore throat, fever and congestion. Although the symptoms may be similar in many people, the flu and COVID-19 are different viruses with different treatments.

Being treated early for either virus reduces the risk of becoming seriously ill.

Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a press release that the clearance of Lucira’s test “is a major step in improving consumer access to diagnostic tests that can be done entirely at home”.

“We remain committed to working with test developers to support the common goal of bringing more accurate and reliable tests to Americans who need them,” Shuren said.

In its press release, the FDA said the Lucira test detected 88.3% of COVID-19 positive samples and 100% of negative samples, in addition to 90.1% of influenza A positive samples and 99 .3% of samples negative for influenza A. There were not enough circulating influenza B cases to be included in the clinical study, the FDA said, but validation confirmed that the test can detect the influenza B in “artificial samples”.

Like other virus tests, false negatives or positives can occur, although the extent to which this occurs may depend on the type of test and other factors. This is why public health advice is to continue to take protective measures if you have symptoms of a respiratory virus but continue to test negative, including avoiding public spaces and contact with people. who are at a higher risk of getting really sick from COVID-19 or the flu.

See also:COVID vaccines in 2023: what we know and what we don’t know

Learn more:The COVID public health emergency is ending. Here’s what will happen to health care

The information in this article is for educational and informational purposes only and is not intended to constitute medical or health advice. Always consult a physician or other qualified health care provider with any questions you may have about a medical condition or health goals.