FDA authorizes first non-prescription at-home COVID-19 test system

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Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. (REUTERS/Andrew Kelly)

SILVER SPRING, Maryland (KVEO) — Performing a COVID-19 test at home will now be possible without a prescription.

The U.S. Food and Drug Administration (FDA) authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit on Wednesday.

The kit is available for use by any individual 18 years and older without a prescription.

This is the first COVID-19 direct-to-consumer test available for individuals without the need for a prescription. With the test, people can self-collect a nasal swab sample at home and send it to LabCorp for evaluation.

If results are positive or invalid, a health care provider will call the individual. If results are negative, users will be alerted by email or through an online portal.

“This is the first kit for consumers to self-collect a nasal sample for COVID-19 in their home that does not require a prescription,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “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.”

To order an at-home test kit by LabCorp, visit here.

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