FDA Issues Emergency Use Authorization for COVID and Influenza Tests
The FDA recently issued an emergency use authorization for over-the-counter at-home tests that can detect influenza and COVID.
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- On February 24, 2023, the FDA issued a press release announcing an emergency use authorization (EUA) for at-home tests that detect influenza and COVID-19. This EUA allows over-the-counter sales of the Lucira COVID-19 and Flu Home Test, marking the first at-home diagnostic test to test for both conditions.
According to the FDA release, this diagnostic tool will be used for individuals over two with respiratory infection symptoms. The manufacturer of the tests advises that children 2–14 years old are to have an adult collect the sample, while those over 14 can self-collect using a nasal swab.
Like the rapid COVID tests that many are familiar with, the nasal swab is used to collect the sample and then placed in a vial. The swab is swirled in the tube and clicked into the test unit for analysis. The test unit will then show positive and negative results for influenza A, Influenza B, and COVID-19.
“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 the FDA announcement. “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.”
Testing on this diagnostic tool revealed that it accurately detected 99.3% and 100% of influenza A and COVID, respectively. The accuracy was slightly lower for positive cases but still significant at 90.1% and 88.3% for influenza A and COVID.
Despite not having enough samples to determine the device’s accuracy in detecting positive cases of Influenza B, the company was able to conclude that the device detected 99.9% of negative cases of Influenza B accurately.
Although the tool has been deemed highly accurate, the FDA cautions consumers to consider the risk of false positive and false negative results. To mitigate the impacts of false results, those with positive tests, persistent symptoms, or a negative COVID and Influenza B test are advised to contact a healthcare professional for follow-up care and additional testing if necessary.
“The collective impact of COVID-19, flu, and RSV underscore the importance of diagnostic tests for respiratory viruses, and the FDA recognizes the benefits that home testing can provide. The agency will continue to use its authorities to increase the number of appropriately accurate and easy-to-use at-home tests available to the public, especially tests that detect these highly contagious respiratory viruses,” stated the FDA in its announcement.
