CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
January 2021—The FDA authorized the first COVID-19 direct-to-consumer test system—LabCorp’s Pixel COVID-19 Test Home Collection Kit, for use by any person 18 years and older without a prescription.
The kit can be purchased online or in a store without a prescription and allows a person to self-collect a nasal swab sample at home and then send the sample to LabCorp for testing. Positive or invalid test results are delivered to the user by phone call from a health care provider. Negative test results are delivered via email or 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,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a press statement from the agency. “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.”