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
