Regulators at the U.S. Food and Drug
Administration on 21 April 2020 authorized the first coronavirus test that lets
people collect a sample at home.
The diagnostic authorization — developed by
testing giant LabCorp — marks the first time the agency has cleared up a
Covid-19 at-home test and ends weeks of back-and-forth between the agency and
companies who have tried to produce their own versions of the tests that would
allow at-home sampling. The LabCorp check will be made available exclusively to
health care staff and first responders who may have been exposed to the virus.
Patients should obtain samples at home if a health care provider suggests the
test after they have completed a questionnaire on Covid-19, and the results are
expected to be available within one to two days after a sample enters the
laboratory, according to the LapCorps website.
Throughout this pandemic business, test
creation has been encouraged to ensure patients have access to accurate
diagnostics, which includes promoting the production of safe and accurate
at-home sample collection options, "FDA commissioner Stephen Hahn said
Tuesday 21 April 2020.
In particular, for experiments involving
the collection of home samples, the company partnered with LabCorp to ensure
that the data from the collection of patient samples at home were as secure and
reliable as the collection of samples at a doctor's office, hospital or other
test site.
The FDA had already approved in March
2020 test of LabCorp under legislation known as an authorization for emergency
use, explicitly tailored to circumstances such as the coronavirus pandemic. The
firm reached out to FDA on April 5 , 2020 to recommend that it amend the
authorization to allow patients to use it at home. Like previous, longer swabs,
LabCorp's at-home test uses a different Q-tip-style cotton nose swab that
allowed patients to examine themselves deep in the back of the nose.
The agency's authorization of the LabCorp
test for home sample processing comes after a recent burst of activity between
the agency and companies including Nurx, Carbon Health, and Everlywell, all of
which had received approval for at-home use of their own Covid-19 tests in
March.
Confusion over the constantly changing
guidance from the FDA tended to lead some organizations to conclude that their
tests were in the clear initially. On March 21 2020, federal regulators
released stern guidance clarifying that no home tests had yet been licensed for
use and advised consumers to be wary of "unauthorized fraudulent test
kits." Responding to the warning, all three companies stopped marketing
their kits directly to customers.
In April, two other companies began selling
Covid-19 tests that let people collect saliva samples at home. The two
companies — MicroGen DX and Vault Health — told on April 10, 2020 that their
tests were cleared for patients to collect spit samples at home. The companies
insist they are permitted to sell the tests because they are ordered by
physicians and processed in certified labs. The FDA, however, remained adamant
that isn’t the case, repeating its previous guidance to STAT on April 10 and
emphasizing that the agency “had not authorized any Covid-19 tests for home
use, including home collection.” Those tests have still not been cleared for
home sample collection
The companies insist that they are licensed
to sell the samples, because they are ordered by doctors and tested in
accredited laboratories. Nevertheless, the FDA remained consistent this is not
the case, repeating its previous guidance to STAT on April 10 and stressing
that the agency "had not approved any Covid-19 home usage tests, including
home testing." These tests have not yet been licensed for home sampling.