FDA Issues EUA for First OTC Influenza-COVID-19 Test Kit

The first over-the-counter (OTC) at-home diagnostic test that detects and differentiates between influenza and SARS-COV-2 received emergency use authorization (EUA) today from the US Food and Drug Administration (FDA). The single-use-at-home test kit from Lucira Health, provides results in approximately 30 minutes based on samples that are self-collected via nasal swab.

The molecular test demonstrated similar performance for COVID-19 and influenza A and B when compared to highly sensitive lab-based PCR tests in clinical trials, according to a Lucira announcement. The test is also the first ever influenza test for OTC use at home.

“COVID-19 and flu look the same, feel the same, spread the same and, unfortunately, can still kill the same,” emphasized David Smith, MD, MAS, professor of medicine and head of the Division of Infectious Disease and Global Public Health at the University of California, San Diego, in the press statement. “Having an at-home molecular test now available should really help people know how to keep their families safe and seek appropriate treatment when they're ill.”

When used by individuals with signs and symptoms of respiratory tract infection, the combination test correctly identified 99.3% of negative and 90.1% of positive influenza A samples, according to the FDA. It detected 100% of the negative and 88.3% of the positive COVID-19 samples and 99.9% of the negative influenza B samples. The agency said it expected the company to continue to test on the influenza B strain, which was not prevalent this year and so findings are based on lab-contrived specimens.

The Lucira COVID-19 & Flu Home Test is meant for use by individuals who have signs and symptoms consistent with a respiratory tract infection, which now includes COVID-19. No prescription is required to purchase the test which can be used by individuals aged ≥14 years, or by an adult who collects a sample for a child aged ≥2 years.

The test fits in the palm of a hand, according to Lucira, and runs on AA batteries. After collecting a sample, a user swirls the swab in a vial that fits into the body of the test kit. In a half hour or less, the test unit displays results indicating either a positive or negative outcome for influenza A, influenza B, and COVID-19. The FDA encourages anyone who uses the home-based test to share the results with their health care provider to contribute to public health reporting and also to receive medical care as needed.

“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,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.

Lucira Health is based in the Bay Area of California and on February 22, 2023, announced it had filed for protection under Chapter 11 of the US Bankruptcy Code. The company had expected to receive the EUA for the test in August before the 2022-2023 respiratory virus season began.

“Unfortunately, we were unable to bridge what became a protracted authorization cycle time within our current capital structure and it remained unclear to us when the regulatory authorization would come through,” the company said. “We remain confident in the role that the new test can play in future respiratory seasons and are honored to have received the first authorization for such a home test.”