The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for Lucira COVID-19 & Flu Home Test, the first over-the-counter (OTC) at-home diagnostic test that can detect and differentiate between SARS-CoV-2 and influenza viruses in individuals 2 years of age and older.
The Lucira COVID-19 & Flu Home test is a single-use, nucleic acid amplification test intended for individuals with signs and symptoms consistent with a respiratory tract infection, including COVID-19. The at-home test works by swabbing the nasal cavity and swirling the sample in a vial, which is then placed in a test unit. Results are displayed in the test unit within 30 minutes and determine whether an individual is positive or negative for: Influenza A, Influenza B, and COVID-19. Individuals should report all results to their health care provider.
In symptomatic individuals, the Lucira COVID-19 & Flu Home Test was found to correctly identify 99.3% of negative and 90.1% of positive Influenza A samples, 100% of negative and 88.3% of positive COVID-19 samples, and 99.9% of negative Influenza B samples. The FDA is requiring Lucira to continue collecting samples to determine the test’s ability to detect Influenza B in real world settings as there were not enough cases of Influenza B circulating to include in the study; the test was able to identify the virus in contrived specimens.
“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. “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.”
It is unclear when the test will be available as Lucira is working to secure a financial partner to resume manufacturing.
- FDA authorizes first over-the-counter at-home test to detect both influenza and COVID-19 viruses. US Food and Drug Administration. February 24, 2023. Accessed February 27, 2023. https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-home-test-detect-both-influenza-and-covid-19-viruses.
- Lucira Health announces FDA authorization of first & only at-home combination COVID-19 & flu test and comments on Chapter 11 Bankruptcy filing. News release. Lucira Health. Accessed February 27, 2023. https://www.globenewswire.com/news-release/2023/02/27/2616067/0/en/Lucira-Health-Announces-FDA-Authorization-of-First-Only-At-Home-Combination-Covid-19-Flu-Test-and-Comments-on-Chapter-11-Bankruptcy-Filing.html.