The US Food and Drug Administration has granted an emergency use authorization for the first non-prescription, over-the-counter Covid-19 test kit for at home use.
The LabCorp Pixel COVID-19 Test Home Collection Kit allows anyone age 18 and older to buy the kit and collect nasal swab samples at home, the FDA said in a news release Wednesday. The samples are then sent to a LabCorp facility for testing.
Positive or invalid results are delivered back to the consumer by phone or through a health care provider. Users will be notified by email or through an online portal if results are negative.
“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,” Dr. Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health, said in a statement.
The kit can help individuals understand their Covid-19 status and make decisions about when self-isolation or quarantine may be necessary, the FDA said. It can also help with health care decisions after discussions with providers.
“With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities,” Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics, said in a statement.
The new kit is now available through the Pixel by LabCorp website and may soon be available in stores, the company said in a news release.
After buying the test, users register the kit on the website and follow the included instructions.
“Test results are securely delivered to the consumer via the Pixel by LabCorp portal,” LabCorp said. “A healthcare provider will counsel consumers who test positive to assist with healthcare treatment and actions.”
The company emphasized in its news release that the new Covid-19 at-home testing kit is not a substitute for a doctor’s visit.