FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Influenza and COVID-19 Viruses
The U.S. Food and Drug Administration has issued an Emergency Use Authorization (EUA) for the first over-the-counter (OTC) home diagnostic test that can differentiate and detect influenza A and B, commonly known as influenza, and SARS-CoV-2, the virus that causes COVID-19. . The Lucira COVID-19 Test & Flu Test is a single-use, at-home test kit that provides results from self-collected nasal swab samples in about 30 minutes.
said Jeff Shoren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. The FDA strongly supports innovation in test development, and we are dedicated to continuing to enhance 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 Lucira COVID-19 & Flu test is a single-use test for individuals who show signs and symptoms consistent with respiratory tract infections, including COVID-19. The test can be purchased without a prescription and is performed entirely at home using nasal swab samples that are self-collected by individuals 14 years of age and older or collected by an adult for individuals 2 years of age or older.
The test works by moving a sample of the sample into a vial placed in the test unit. In 30 minutes or less, the testing unit will display results showing whether the person has tested positive or negative for each of the following: influenza A, influenza B, and COVID-19. Individuals should report all results obtained to their healthcare provider for public health reporting and receive appropriate medical care.
In symptomatic individuals, the Lucira COVID-19 & Flu Test correctly identified 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. Because there are not currently enough cases of influenza B to be included in a clinical study, validation confirmed that the test can identify the virus in fabricated samples, and EU law requires Lucera to continue collecting samples to study the test’s ability to detect influenza B in real-world settings. .
As with all rapid diagnostic tests, there is a risk of false positive and false negative results. Individuals who test positive for influenza or COVID-19 should take appropriate precautions to avoid spreading the virus and should seek follow-up care with a physician or healthcare provider as additional testing may be necessary. Negative results for SARS-CoV-2 and influenza B, if required for patient management, must be confirmed by an authorized or approved molecular test performed in a CLIA-accredited laboratory that meets requirements for high or medium complexity testing. Individuals who test negative and continue to have symptoms of fever, cough, and/or shortness of breath may still have a respiratory infection and should seek follow-up care with their healthcare provider.
The combined impact of COVID-19, influenza, and RSV underscores the importance of diagnostic testing for respiratory viruses, and the FDA recognizes the benefits home tests can provide. The agency will continue to use its powers to increase the number of accurate, appropriate, easy-to-use home tests available to the public, especially those that detect highly contagious respiratory viruses.
