FDA authorizes first non-prescription COVID-19 test for at-home use

Those in need of a COVID-19 test may no longer need to leave the privacy of their homes, even to gather a prescription for it, with news of authorization granted by the United States Food and Drug Administration to the LabCorp Pixel COVID-19 Test Home Collection Kit.

The first no prescription required test system authorized for COVID-19, Pixel will allow patients to self-collect samples via nasal swab. Those samples can then be sent for proper testing at LabCorp, delivering results to health care providers. The providers can then notify users of their results, either by email or online portal if negative or by phone call if positive or invalid. The pair can then determine the next steps, such as quarantine.

Kits will be available for purchase both online and in stores.

“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,” Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said. “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 effort has the potential to speed up a time-consuming process and relieve some of the pressure on the U.S. health care system heading into the holiday season — and, what many experts worry, could also be a busy season for flu and COVID. While several vaccines are nearing the distribution stage, they will likely not be available for widespread use yet for some time. As a result, tests like Pixel remain a vital step for the FDA and health organizations to combat the ongoing pandemic.