What You Should Know:
– FDA approves Everlywell’s COVID-19 Test Home Collection Kit under the emergency use authorization (EUA) allows an individual to self-collect a nasal sample at home using Everlywell’s authorized kit.
– The Everlywell home-collection kit is currently the only authorized COVID-19 at-home sample collection kit for use with multiple authorized COVID-19 diagnostic tests.
The U.S. Food and Drug Administration (FDA) has issued emergency use authorization (EUA) to digital health company Everlywell for its COVID-19 Test Home Collection Kit that can be sent to specified laboratories for COVID-19 diagnostic testing.
How the At-Home COVID-19 Test Home Collection Kit Works
Everlywell’s kit is authorized to be used by individuals at home who have been screened using an online questionnaire that is reviewed by a health care provider. This allows an individual to self-collect a nasal sample at home using Everlywell’s authorized kit. 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. Additional tests may be authorized for use with the Everlywell at-home collection kit in the future, provided data are submitted in an EUA request that demonstrates the accuracy of each test when used with the Everlywell at-home collection kit.
Nasal Swab COVID-19 Test Samples Shipping to CLIA-Certified Labs
Today’s 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. Once patients self-swab to collect their nasal sample, they will ship the sample overnight to a specific CLIA-certified lab that is running one of the in vitro diagnostic molecular tests authorized under a separate EUA for use with the Everlywell at-home sample collection kit. The labs authorized to test specimens collected using the Everlywell at-home collection kit are Fulgent Therapeutics and Assurance Scientific Laboratories. Results will be returned to the patient through Everlywell’s independent physician network and their online portal.
Availability
The Everlywell home-collection kit is currently the only authorized COVID-19 at-home sample collection kit for use with multiple authorized COVID-19 diagnostic tests. The kit and associated tests are available by prescription only. It is important to note that this is not a general authorization for at-home collection of patient samples using other collection kits, swabs, media, or tests, or for tests fully conducted at home.
