FDA Authorizes First At-Home Test To Detect Flu And COVID-19

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The U.S. Food and Drug Administration has approved the first over-the-counter or OTC at-home diagnostic test to detect both influenza and COVID-19 viruses. The decision is part of its efforts to increase the availability of home diagnostic tests.

In a statement, the agency said it has issued an emergency use authorization or EUA for Lucira Health, Inc.'s Lucira COVID-19 & Flu Home 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 single-use at-home test kit provides results from self-collected nasal swab samples in around 30 minutes.

The test is for individuals with signs and symptoms consistent with a respiratory tract infection, including COVID-19. They can purchase the kits without a prescription and can perform completely at-home. Nasal swab samples can be self-collected by individuals ages 14 years or older or collected by an adult for individuals 2 years of age or older.

They then need to swirl 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 are asked to report all results obtained to their healthcare provider for public health reporting and to receive appropriate medical care.

The agency noted that the Lucira COVID-19 & Flu Home Test correctly identified 99.3% of negative and 90.1% of positive Influenza A samples in individuals with symptoms. It also identified 100% of negative and 88.3% of positive COVID-19 samples and 99.9% of negative Influenza B samples.

Meanwhile, there are currently not enough cases of Influenza B circulating to include in a clinical study. The validation has 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.

The FDA said it 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.

Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said, "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. ... we are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs."

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