LabCorp’s Pixel COVID-19 Test Home Collection Kit has been authorized for emergency use by the FDA — the first COVID-19 direct-to-consumer (non-prescription) test system. The test is authorized for individuals 18 and older and allows an individual to self-collect a nasal swab sample at home and then send that sample for testing to LabCorp. Positive or invalid test results are then delivered to the user by phone call from a health care provider. Negative test results are delivered via email or online portal.
This home sample collection kit can be purchased online or in a store without a prescription. It is intended to enable users to access information about their COVID-19 infection status that could aid with determining if self-isolation (quarantine) is appropriate and to assist with health care decisions after discussion with a healthcare professional.
“With the first over-the-counter at-home collection kit ever authorized by the FDA for COVID-19, we are empowering people to learn about their health and make confident decisions,” said Dr Brian Caveney, chief medical officer and president of LabCorp Diagnostics. “With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities.”
Upon purchase, users register their Pixel by LabCorp COVID-19 collection kit at the Pixel by LabCorp website and follow the instructions included. Test results are securely delivered to the consumer via the Pixel by LabCorp portal. A healthcare provider will counsel consumers who test positive to assist with healthcare treatment and actions. The Pixel by LabCorp COVID-19 collection kit is not a substitute for visits to a healthcare professional and is for use in adults 18 and older.
In April, the Pixel was the first COVID-19 RT-PCR Test authorized to process home-collected samples from patients, with a prescription needed. The new FDA authorization allows the test without 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, MD, JD, director of 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.”