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FDA authorises first at-home COVID-19 and flu test for emergency use

The single-use test uses nasal swab samples and provides results in about 30 minutes


The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to the first at-home over-the-counter diagnostic test to detect both influenza and COVID-19 viruses.

The Lucira COVID-19 & Flu Home Test is indicated for those who have signs and symptoms that are consistent with a respiratory tract infection, including COVID-19, and can be purchased without a prescription.

The single-use test uses self-collected nasal swab samples and provides results in about 30 minutes, the agency said, with diagnoses able to differentiate between both influenza A and B viruses.

In a statement, the FDA also outlined that all results should be reported to healthcare providers for public health reporting and to ensure patients receive appropriate medical care.

The decision is supported by results that showed the test correctly identified 99.3% of negative and 90.1% of positive influenza A samples, 100% of negative and 88.3% of positive COVID-19 samples and 99.9% of negative influenza B samples in symptomatic individuals.

Since there are currently not enough cases of influenza B circulating to include in a clinical study, the EUA requires Lucira Health to continue to collect samples to study the test’s ability to detect the virus in real-world settings.

Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said the authorisation was a “major milestone” in increasing the availability of home diagnostic tests, adding: “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.”

The agency originally granted EUA for the test in November 2022 for point-of-care use in healthcare settings.

Erik Engelson, president and chief executive officer of Lucira Health, explained at the time: “COVID-19 and flu viruses can both cause serious illness with similar symptoms, but each has unique prescription treatments that require diagnosis early in the infection to be effective.

“The inaccuracy of antigen COVID-19 tests makes such tests inadequate to use for early differential diagnosis of flu versus COVID-19.”

Citing the impact of COVID-19, flu and RSV, the FDA stated it ‘recognises the benefits that home testing can provide’ and will continue to work to increase the number of tests available to the public.

Article by
Emily Kimber

27th February 2023

From: Regulatory



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