WASHINGTON — The FDA granted an emergency use authorization (EUA) to LabCorp’s Pixel COVID-19 Test Home Collection Kit, the first over-the-counter SARS-CoV-2 test that can be used at home by any individual 18 years of age or older.
The home sample kit, which can be purchased online or in store without a prescription, allows users to self-collect nasal swab samples and submit them to the product’s manufacturer for analysis—if the results are positive or invalid, the patient will receive a call from a healthcare professional; negative test results will be delivered via email or online portal.
With this approval, individuals will be able to access information on their Covid-19 infection status without the need to go out and see their healthcare provider, allowing them to determine whether self-quarantine is needed and follow-up with their provider after testing, the FDA explained.
“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, in a statement. “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.”
“With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities,” Brian Caveney, MD, chief medical officer and president of LabCorp Diagnostics, said in a company press release.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 190
Topic ID: 79,190,730,933,190,926,192,927,151,928,925,934
