FDA Authorizes the First at-Home Over-the-Counter Coronavirus Test.
The Ellume COVID-19 Home Test was authorized by the Food and Drug Administration (FDA) on Dec. 15.
It can be bought without
a prescription at drug stores.
The antigen test, developed by Australian digital diagnostics company Ellume, .
requires a nasal swab sample that
is placed into an analyzer synced
with a smartphone app via Bluetooth.
The results appear on
the smartphone app
within 20 minutes.
Antigen testing delivers quick results, but it's not as sensitive as polymerase chain reaction (PCR) testing.
This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab, Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, via statement.
However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic, Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, via statement.
Ellume intends to produce
over 3 million tests in January,
which are expected to
cost $30 or less