FDA Approves ‘At-Home’ Coronavirus Test Kit

The Food and Drug Administration (FDA) approved an over-the-counter coronavirus test kit that consumers can take at home.

LapCorp’s Pixel COVID-29 Test Home Collection Kit is for use by adults 18 and over, and allows them to collect a nasal swab sample at home. Then the consumer sends the sample into LabCorp for testing. If the results are either positive or invalid, a health care provider will call. If the results are negative, they will receive the results via email or online portal.

People will be able to purchase the kit in store or online, and 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,” said Jeff Shuren, director of the 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.”

Fox News reports:

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.

Wonder how accurate these tests will be, since so many other coronavirus tests are unreliable.

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