FDA authorizes first home test that can detect both flu and Covid-19

CNN
—

If you have a fever and a cough, you no longer necessarily need to see a doctor to see if it’s the flu or Covid-19.

On Friday, the US Food and Drug Administration authorized the first home test that can tell users whether they have the flu and/or Covid-19.

The test, created by California biotech company Lucira Health, uses a single self-administered nasal swab and can provide results in about half an hour. The test can be purchased without a prescription. It is authorized for anyone 14 years and older to pick it up themselves, or an adult can give it to a child 2 years or older.

The test can identify a negative result for influenza A with greater than 99% accuracy and a positive result with greater than 90% accuracy. It is 100% accurate for negative Covid-19 samples and over 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 test when enough virus is in circulation. But in laboratory studies, it caught almost 100% of negative cases.

All tests carry the risk of false positive or negative results. People who test positive for the flu or Covid-19 should take precautions so they don’t spread the disease. Negative results must be confirmed with a lab test, the FDA said, “if necessary for patient management.”

Studies show that a home test can be less accurate than a lab test because users may not get enough of a sample for a valid result. Healthcare providers may also have more sensitive tests.

People who have flu or covid-like symptoms but test negative may have a different type of respiratory infection and need follow-up care.

Historically, doctors have been reluctant to leave testing to their patients, but the Covid-19 pandemic changed some of that sentiment. Studies have shown that people do not need medical training to test themselves for respiratory disease.

Although the intensity of the pandemic has eased and the number of cases is decreasing, the US still had 236,131 new cases, 2,407 deaths and an average of 3,461 hospitalizations this week, according to the US Centers for Disease Control and Prevention. Seasonal flu activity is low nationwide, the CDC says.

Tests for Covid-19 and the flu are helpful because both illnesses can be treated with different medications, and those medications work best if taken as soon as possible after the onset of symptoms.

“Today’s approval of the first OTC test that can detect Influenza A and B, along with SARS-CoV-2, is an important milestone in increasing 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.