The U.S. FDA authorized Burlington, N.C.-based Laboratory Corporation of America Holdings’ (Labcorp’s) Pixel COVID-19 test home collection kit for use by any individual 18 years and older without a prescription.
Pixel is authorized as the first COVID-19 direct-to-consumer (non-prescription) test system to allow an individual to self-collect a nasal swab sample at home and then send that sample for testing to Labcorp. Positive or invalid test results are then delivered to the user by phone call from a health care provider. Negative test results are delivered via email or online portal.
This home sample collection kit can be purchased online or in a store without a prescription. It is intended to enable users to access information about their COVID-19 infection status that could aid with determining if quarantining is appropriate and to assist with health care decisions after discussion with a health care professional.
“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 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.”
In November, Emeryville, Calif.-based Lucira Health Inc. became the first company to secure U.S. FDA emergency use authorization for a prescription molecular diagnostic test for COVID-19 that can be performed from start to finish in the convenience of one’s home. That single-use, COVID-19 All-in-One Test Kit employs a simple ‘swab, stir and detect’ design that yields results within 30 minutes – enabling individuals who expect they have the virus to get results while isolating at home.