FDA authorizes first at-home test for both COVID and flu

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Sick and wondering if you might have COVID-19 or the flu? A new test approved for use by the Food and Drug Administration promises to tell you just that.

The Lucira COVID-19 and Flu Home Test is available over the counter and provides results from a self-collected sample in approximately 30 minutes. The new test differentiates between COVID and flu and indicates whether the user is positive or negative for either virus based on a nasal swab. It is the first such test to receive an Emergency Use Authorization (EUA) from the FDA.

“Today’s authorization of the first OTC test that detects SARS-CoV-2 as well as Influenza A and B is a major milestone in bringing greater consumer access to diagnostic tests,” said Jeff Shuren, director of the FDA. The FDA’s Center for Devices and Radiological Health said in a statement.

The agency said it remains committed to increasing the availability of at-home tests that can detect the infectious respiratory virus.

Influenza A, B and COVID-19

Lucira’s single-use diagnostic test is designed for people with symptoms of a respiratory viral infection consistent with COVID-19 or the flu, and is suitable for anyone two years of age or older, according to the company.

The test works similarly to other kits approved for the detection of COVID-19. Test takers squirt the sample swab into a vial, which then moves to a testing unit. The device gives an indication of whether a person is positive or negative for influenza A, influenza B or COVID-19.

According to the EUA, it correctly identified 99.3% of negative and 90.1% of positive Flu A samples; 99.9% negative Flu B samples; and 100% negative and 88.3% positive COVID-19 samples.

Without diagnostic testing, COVID-19 and the flu can easily be mistaken for each other.

“COVID-19 and the flu look similar, feel similar, spread similar and, unfortunately, can still kill the same,” Dr. Davey Smith, chief of infectious disease at the University of California – San Diego, announced in a statement. Said FDA approval for Lucira test kit. “Having molecular testing now available at home should really help people learn how to keep their families safe and seek appropriate treatment if they do get sick.”

Despite receiving FDA approval for its product, Lucira struggled financially and filed for Chapter 11 bankruptcy protection just days before the agency was to authorize the test kit. This raises the question of whether the test will ever be widely available to consumers. For now, the kit is available for sale on Lucira’s website for $99.

Lucira CEO Eric Engelson said in a statement that the company is looking for a potential strategic or financial partner to resume manufacturing and development of the product.

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