FDA authorizes first at-home test that can detect both flu, COVID-19
(CNN) — If you’ve got a fever and a cough, you don’t necessarily have to go to the doctor anymore to find out if it’s the flu or COVID-19.
On Friday, the U.S. Food and Drug Administration authorized what it says is the first at-home test that can tell users if they have the flu and/or COVID-19.
The test, made by California biotech company Lucira Health, uses a single self-collected nasal swab and can provide results in about half an hour. The test can be bought without a prescription. It’s authorized for anyone 14 and older for self-collection, or an adult can give it to a child 2 or older.
The test is able to identify a negative result for influenza A with more than 99% accuracy and a positive result with more than 90% accuracy. It’s 100% accurate for negative COVID-19 samples and more than 88% accurate for positive results.
There weren’t enough influenza B cases while Lucira was testing the product to measure that performance, so the company says it will have to do a real-world test when there is enough virus in circulation. But in lab studies, it caught nearly 100% of negative cases.
All tests carry a risk of false positive or negative results. People who test positive for flu or COVID-19 should take precautions so they don’t spread the illness. Negative results should be confirmed with a lab test, the FDA said, “if necessary for patient management.”
Studies show that an at-home test can be less accurate than a lab test because users might not get enough of a sample for a valid result. Health-care providers also may have more sensitive tests.
People who have flulike or COVID-like symptoms but test negative may have a different kind of respiratory infection and should get followup care.
Historically, doctors have been reluctant to leave testing to their patients, but the COVID-19 pandemic changed some of that sentiment. Studies have found that people don’t need medical training to test themselves for respiratory illnesses.
Although the intensity of the pandemic has slowed and cases are declining, the United States still had 236,131 new cases, 2,407 deaths and an average of 3,461 hospitalizations this week, according to the U.S. Centers for Disease Control and Prevention. Seasonal flu activity is low nationally, the CDC says.
Tests for COVID-19 and flu are helpful because both illnesses can be treated with different medications, and those drugs work best when taken as soon as possible after symptoms begin.
“Today’s authorization of the first OTC test that can detect Influenza A and B, along with SARS-CoV-2, is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement Friday.