The Food and Drug Administration approved an emergency use authorization for an at-home coronavirus test.
The FDA authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit, a direct-to-consumer testing kit that allows users to collect a nasal swab sample at home and mail it to LabCorp for testing, according to a press release. Users are notified of positive results via telephone from a healthcare provider, and negative results are delivered in an email.
“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.”
The Pixel testing kits are reserved for those who have symptoms of COVID-19, those who were potentially exposed to the coronavirus, and anyone who was recommended for testing by a health professional, according to the LabCorp website.
“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,” Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics, said in a statement. “With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities.”
Out of pocket, the at-home testing kit costs $119. Qualifying individuals can request to have a kit mailed to them. LabCorp states that insurance will cover any upfront costs, and those without insurance can request that the company use federal funds to cover the cost of the test. There is a $10 “physician services” fee.
Results from the test can be expected within two days of the sample being received by the lab.
