The FDA has granted emergency use authorization for the first at-home diagnostic test that can distinguish between influenza A and B, also known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Test is a single-use kit that provides results from self-collected nasal swab samples in about 30 minutes.
Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health, said that the authorization of this test is a significant step in making diagnostic tests accessible to consumers that can be performed entirely at home. The FDA is committed to supporting the development of accurate and reliable at-home infectious disease tests to better support public health needs.
The Lucira COVID-19 & Flu Test is designed for individuals with symptoms consistent with respiratory tract infections, including COVID-19. The test can be purchased without a prescription and is suitable for use by individuals aged 14 years and older or by an adult for individuals aged 2 years or older.
The test involves swirling the nasal swab sample in a vial and placing it in the test unit. In less than 30 minutes, the test unit will display the results for Influenza A, Influenza B, and COVID-19.
The 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 in individuals with symptoms. The test's ability to detect Influenza B in real-world settings will continue to be studied.
Individuals who test positive for either flu or COVID-19 should take appropriate precautions to prevent the spread of the virus and seek follow-up care with their physician or healthcare provider as additional testing may be necessary. Negative results for SARS-CoV-2 and influenza B should be confirmed, if necessary for patient management, with an authorized or cleared molecular test performed in a CLIA-certified laboratory.
The FDA recognizes the importance of diagnostic tests for respiratory viruses, especially in light of the impact of COVID-19, flu, and RSV. The agency will continue to work to increase the availability of accurate and easy-to-use at-home tests for these highly contagious respiratory viruses.
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