The U.S. Food and Drug Administration has authorized the first over-the-counter at-home test that will test for both the flu and COVID-19 viruses.
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In a news release, the FDA authorized an emergency authorization the first over-the-counter at-home diagnostic test for both the flu and COVID-19. It’s called the Lucira COVID-19 and Flu Home Test. It is single-use and provides results through a nasal swab similar to a COVID-19 test and results come back in about 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, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, in the news release. “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.”
This is also the first at-home test that will test for the flu at home, according to The Associated Press.
The test is meant to be used by someone 14 years or older, according to The New York Times. It can also be used by an adult who is collecting a sample from a child who is 2 years old or younger.
The newspaper reported that the developer of the test, Lucira Health, announced on Wednesday its bankruptcy plan and they said that they expected the emergency-use authorization would have been in August of last year prior to the flu season. The company said that “it had high expenditures as it moved forward with manufacturing the combination tests.”
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Director of the FDA’s Center for Devices and Radiological Health Jeff Shuren said the authorization is “a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home,” according to the AP.
The FDA said that they realize that there is a lot of benefits that at-home testing will provide for testing for COVID-19, RSV, and the flu.
“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,” said the FDA.
The FDA said the test will be available for purchase without a prescription.
