COVID-19: First Standalone At-home Sample Collection Kit Receives FDA Approval

The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for an at-home sample collection kit that can then be sent to specified laboratories for coronavirus disease 2019 (COVID-19) testing.

Everlywell, Inc. received the EUA on May 16, 2020 for their COVID-19 Test Home Collection Kit, the only authorized at-home sample collection kit for use with multiple authorized COVID-19 diagnostic tests.

“The authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a press release. “Today’s action is also another great example of public-private partnerships in which data from a privately funded study was used by industry to support an EUA request, saving precious time as we continue our fight against this pandemic.”

The authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure.

The COVID-19 Test Home Collection Kit can be used by individuals at home who have been screened using an online questionnaire that is reviewed by a health care provider.

The COVID-19 Test Home Collection Kit permits testing of a sample that a patient collects from inside the nose using the kit’s nasal swabs and a tube filled with saline to transport the sample back to a specified lab.

Patients will ship the samples overnight to a clinical laboratory improvement amendments (CLIA)-certified laboratory that is running one of the in vitro diagnostic molecular tests that were issued separate EUAs for use with the COVID-19 Test Home Collection Kit.

There are currently 2 laboratories that have been issued EUAs to test specimens collected using the COVID-19 Test Home Collection Kit, which are Fulgent Therapeutics and Assurance Scientific Laboratories.

Results are returned to the patient through Everlywell’s independent physician network and their online portal.

It is important to note that the EUA issued to Everlywell Inc. is not a general authorization for at-home collection of patient samples using other collection kits, swabs, media, tests, or tests fully conducted at home. The kit and associated tests are available by prescription only.

For more COVID-19 coverage for primary care, visit our COVID-19 Resource Page.