The United States Food and Drug Administration (FDA) approved LabCorp's Pixel COVID-19 Test Home Selection kit for use without a prescription. This device, approved as the first COVID-19 non-prescription test system, enables a person to collect a nasal swab sample at home and then send it to LabCorp for testing. A phone call from a health care provider then provides positive or invalid test results to the user.
"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, M.D., J.D., 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."
The collecting kit for home samples can be bought online or in a shop without a prescription. The aim is to provide users with access to information on the status of COVID 19 that may assist in deciding whether self-isolation (quarantine) is necessary and in helping health decision-making following consultations with a health professional.