FDA Authorizes Nonprescription, At-Home COVID-19 Test

Carolyn Crist

December 10, 2020

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

The FDA issued an emergency use authorization on Wednesday for the first non-prescription at-home COVID-19 test, which allows users to swab a sample at home and then send it to a lab for processing.

LabCorp's Pixel COVID-19 Test Home Collection Kit can be purchased online or over-the-counter at a store, according to an FDA announcement. Other at-home tests have only been available by prescription.

"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," Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said in the statement.

LabCorp's Pixel COVID-19 Test Home Collection Kit can be purchased online or over-the-counter at a store. The test allows users to swab a sample at home and then send it to a lab for processing.

Anyone over age 18 can buy the test kit and register it on LabCorp's website. Then they collect a nasal swab sample at home and send the sample to a LabCorp facility for testing.

Positive or invalid test results are communicated by phone from one of the company's health care providers. Negative test results are delivered by email or LabCorp's online portal.

The at-home test is meant to help people determine their COVID-19 status, decide whether they need to quarantine and make health care decisions with their doctor, the FDA wrote.

"With this authorization, we can help more people get tested, reduce the spread of the virus, and improve the health of our communities," Brian Caveney, MD, chief medical officer and president of LabCorp Diagnostics, said in a statement.

For now, the kit is available on the Pixel by LabCorp website and may soon be available in stores. The kit is free under most health insurance plans, and those without health insurance can take an eligibility survey to qualify for federal funding to cover the cost. Otherwise, the out-of-pocket cost for the test kit is $119.

Sources:

FDA, "FDA Authorizes First Direct-to-Consumer COVID-19 Test System."

LabCorp, "LabCorp Receives FDA Authorization to Make At-Home COVID-19 Collection Kits Available Through Retail."

LabCorp, "Pixel by LabCorp."

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