FDA Issues EUA for First OTC At-Home Test That Can Detect Influenza A/B, COVID-19

The FDA issued an emergency use authorization (EUA) for an over-the-counter (OTC) at-home diagnostic test (COVID-19 & Flu Test; Lucira Health) that can differentiate between influenza (flu) A and B, and detect COVID-19. The test is a single-use kit that uses self-collected nasal swab samples to provide results in approximately 30 minutes.

“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, in a press release. “The FDA strongly supports innovation in test development, and we are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs. 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.”

The test can be purchased without a prescription and performed by patients at home without intervention by a health care professional. According to the press release, it is advised that individuals aged 2 years or older have their sample collected by an adult, although individuals aged 14 years and older should be able to collect the nasal swab sample by themselves.

The collection process is conducted by swirling the sample swab in a vial placed in the test unit. After waiting 30 minutes or less, the test unit will display positive or negative results for influenza A, influenza B, and COVID-19. Based on these results, the individuals should inform their health care provider to receive medical care as necessary, according to the press release.

The EUA for the test is based on data that showed the test was able to correctly identify 100% of negative and 88.3% of positive COVID-19 samples, 99.3% of negative and 90.1% of positive influenza A samples, and 99.9% of negative influenza B samples. However, because of the lack of test subjects available for influenza B due to the low circulation of the virus, investigators used contrived specimens to validate the test’s detection of the virus. As a part of the EUA requirements, Lucira will continue to collect real-world samples to investigate the test’s efficacy in the detection of influenza B.

Notably, there remains the potential for false positive and false negative results, according to the press release. Currently, all rapid diagnostic tests have this risk associated with their use. For this reason, individuals who test positive for influenza A or COVID-19 should take precautions to avoid spreading the virus and then follow-up with a health care provider as additional testing may be necessary.

Furthermore, negative results for COVID-19 and influenza B should also be confirmed, as necessary, with an authorized or cleared molecular test performed in a CLIA-certified laboratory. Additionally, individuals with respiratory infection symptoms who test negative and continue to experience symptoms of fever, cough, and/or shortness of breath may still have a respiratory infection, so following up with a health care provider may be necessary to ascertain the source of the symptoms.

As COVID-19, flu, and RSV continue to circulate in US populations, the FDA explained that the importance of diagnostic tests, including those available for at-home use, remain clear. The agency also noted that it would continue to exercise its authorities through EUAs to provide the public with access to these tests. Particularly, the agency noted that a focus will remain on authorizing accurate and easy to use at-home tests for highly contagious respiratory viruses in order to support US public health.

Reference

FDA. FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Influenza and COVID-19 Viruses. FDA website. February 24, 2023. Accessed February 24, 2023. https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-home-test-detect-both-influenza-and-covid-19-viruses?utm_medium=email&utm_source=govdelivery