FDA Authorizes First At-Home Test for COVID-19, Flu

February 27, 2023

The FDA has issued an emergency use authorization (EUA) for the nation’s first at-home test that can detect COVID-19 and the flu at the same time.

On Friday, the agency said the EUA for Lucira’s over-the-counter test is a milestone during the pandemic “bringing greater consumer access to diagnostic tests that can be performed entirely at home.”

“We remain committed to working with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.

Here’s what you need to know:

• What it detects:  Influenza A, Influenza B, and COVID-19.
• How it works:  The at-home test kit provides results from self-collected nasal swab samples in about 30 minutes. People 14 and older can collect their own results, and those between 2 and 13 can get results with help from an adult.
• Study results:  Lucira’s at-home test correctly identified 99.3 percent of negative and 90.1 percent of positive Influenza A samples; 100 percent of negative and 88.3 percent of positive COVID-19 samples; and 99.9 percent of negative Influenza B samples.
• Uncertain distribution:  The test has an uncertain future after its manufacturer filed for bankruptcy according to media reports. In its filing, the company said the protracted FDA review led to lost revenue for the combined test kit during the 2022–2023 flu season.
• Quotable:  “The collective impact of COVID-19, flu, and RSV underscore the importance of diagnostic tests for respiratory viruses, and the FDA recognizes the benefits that home testing can provide,” the agency said in a statement.

The FDA noted that patients who test positive should follow-up with their health care provider for additional guidance and testing if necessary. Additional information about the EUA is available online.

HAP continues to urge everyone to stay up to date on their flu and COVID-19 vaccinations. Learn more about appointments available in your community.