FDA authorizes first direct-to-consumer COVID-19 test
Click Here to Manage Email Alerts
The FDA has authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit ⎼⎼ the first direct-to-consumer COVID-19 test kit ⎼⎼ for use by anyone aged 18 years and older.
The test kit allows an individual to self-collect a nasal swab sample at home and then send it for testing to LabCorp, according to the FDA. Positive or invalid test results are then delivered to the user by phone call from a health care provider, whereas negative test results are delivered via email or an online portal.
According to the FDA, the kit can be purchased online or in a store without a prescription. It will also allow users to access information about their COVID-19 infection status that could help them determine whether they need to self-isolate 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,” Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, said in a press release. “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.”
Collapse
Press Release
Read more about
Click Here to Manage Email Alerts