The U.S. Food and Drug Administration (FDA) granted an emergency use authorization (EUA) for an at-home sample collection kit for COVID-19 diagnostic testing, the agency said in a press release.
Specifically, the FDA issued an EUA for the Everlywell COVID-19 Test Home Collection Kit, which can be used by patients who have been screened using an online questionnaire that is reviewed by a healthcare provider.
The FDA has also authorized two COVID-19 diagnostic tests, performed at specific laboratories, for use with samples collected using the Everlywell COVID-19 Test Home Collection Kit. These tests have been authorized under separate, individual EUAs. The labs authorized to test specimens collected using the Everlywell at-home collection kit are Fulgent Therapeutics and Assurance Scientific Laboratories.
The FDA said additional tests may be authorized for use with the Everlywell at-home collection kit in the future.
Test results will be returned to the patient through Everlywell’s independent physician network and the company’s online portal, the FDA said.
THE FDA EUA for the Everlywell COVID-19 Test Home Collection Kit permits testing of a sample collected from inside the patient’s nose using the authorized self-collection kit that contains nasal swabs to collect a sample and a tube filled with saline to transport the sample back to a specified lab.
