FDA approves at-home COVID-19 test kit that doesn't require a prescription

Food and Drug Administration
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The Food and Drug Administration has authorized a COVID-19 test kit for use at home with no need for a prescription.

The FDA announced Wednesday it has granted emergency use authorization to LabCorp's Pixel COVID-19 Test Home Collection Kit, which is the first such at-home coronavirus test kit that doesn't require a prescription, CNN and The Washington Post report.

"While many home collection kits can be prescribed with a simple online questionnaire, this newly authorized direct-to-consumer collection kit removes that step from the process, allowing anyone to collect their sample and send it to the lab for processing," Dr. Jeff Shuren, the director of the FDA's Center for Devices and Radiological Health, said.

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A nasal swab sample can be self-collected using the kit and sent to LabCorp for testing, with positive results being provided over the phone and negative results being provided either through email or an online portal, the FDA said. Previously, the FDA granted emergency use authorization to the Lucira COVID-19 All-In-One Test Kit, but that requires a prescription, CNN notes.

"With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities," LabCorp Diagnostics Chief Medical Officer and President Dr. Brian Caveney said.

LabCorp said the kit is available through its website to adults and that this FDA approval will allow it to "potentially distribute the kit through retail channels" as well.

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