FDA authorizes first over-the-counter, non-prescription Covid-19 test system for home use

FDA authorizes first over-the-counter, non-prescription Covid-19 test system for home use

 

The FDA has granted an EUA 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 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 healthcare 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 healthcare 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.