FDA Authorizes First OTC At-Home Test for COVID-19 and Flu
Test can be purchased without a prescription and gives results in about 30 minutes
The U.S. Food and Drug Administration recently issued an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test is a single-use at-home test kit that provides results from self-collected nasal swab samples in roughly 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. “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 Lucira COVID-19 & Flu Home Test is a single-use test for individuals with signs and symptoms consistent with a respiratory tract infection, including COVID-19. The test can be purchased without a prescription and performed completely at home using nasal swab samples self-collected by individuals ages 14 years and older or collected by an adult for individuals two years of age or older.
The test works by swirling the sample swab in a vial that is placed in the test unit. In 30 minutes or less, the test unit will display the results that show whether a person is positive or negative for each of the following: influenza A, influenza B, and COVID-19.
Individuals should report all results obtained to their health care provider for public health reporting and to receive appropriate medical care.
In those with symptoms, the Lucira COVID-19 & Flu Home Test correctly identified 99.3 percent of negative and 90.1 percent of positive influenza A samples, 100 percent of negative and 88.3 percent of positive COVID-19 samples, and 99.9 percent of negative influenza B samples.
Since there are currently not enough cases of influenza B circulating to include in a clinical study, validation confirmed that the test can identify the virus in contrived specimens. The EUA requires Lucira to continue to collect samples to study the test’s ability to detect influenza B in real-world settings.
Risks associated with rapid diagnostic tests
As with all rapid diagnostic tests, there is a risk of false positive and false negative results. Individuals who test positive for either flu or COVID-19 should take appropriate precautions to avoid spreading the virus and seek follow-up care with their physician or health care 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 that meets the requirements to perform high or moderate complexity tests. Individuals who test negative and continue to experience symptoms of fever, cough, and/or shortness of breath may still have a respiratory infection and should seek follow-up care with their health care provider.
The collective impact of COVID-19, flu, and RSV underscores 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.
- This press release was originally published on the U.S Food & Drug Administration website