Nonprescription at-home coronavirus test gets FDA approval

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The Food and Drug Administration authorized the first over-the-counter, at-home coronavirus test kit  for consumers on Wednesday. LapCorp’s Pixel COVID-19 Test Home Collection Kit is intended for use by anyone 18 years and older and allows people to self-collect a nasal swab sample at home and send it to LabCorp for testing. If the results are positive, or deemed invalid, the consumer receives a phone call from a health care provider. Negative results are developed via email or online portal.  

The kit is available for purchase either online or in a store.

The test does not require a prescription. 

“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,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a press release posted to the FDA website. “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.”

The approval comes nearly a month after the agency granted emergency use authorization (EUA) to another self-test kit, but that one requires a prescription. The Lucira COVID-19 All-In-One Test Kit is authorized for home use with self-collected nasal swabs for individuals 14 and older who are suspected of COVID-19 infection by their health care provider. It was also authorized for point-of-care settings for all ages, but samples in patients younger than 14 must be collected by a health care provider.

Unlike LabCorp’s test, Lucira’s does not require an outside lab.

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