FDA Approves First Direct-to-Consumer COVID-19 Test

The US Food and Drug Administration (FDA) has granted authorization to LabCorp’s Pixel COVID-19 test, a home collection kit. The test has been approved for adults aged 18 years or older and does not require a prescription. This is the first COVID-19 test available to consumers without a 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,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiologic Health.

The collection kit includes a nasal swab for at-home sample collection. The individual registers the test on the Pixel by LabCorp website and then follows the included instructions. The sample is sent to LabCorp for testing and processing results.

Consumers with negative test results will receive an email or alert via an online portal, whereas consumers with a positive or invalid test will receive a phone call from a health care provider. Health care providers counsel persons with positive test results to help determine next steps for treatment.

—Audrey Amos, PharmD

Reference:

Coronavirus (COVID-19) update: FDA authorizes first direct-to-consumer COVID-19 test system. News Release. US Food and Drug Administration. December 9, 2020. Accessed December 11, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-direct-consumer-covid-19-test-syste