U.S. health officials have authorized two more over-the-counter COVID-19 tests that can be used at home to get rapid results.
The move by the Food and Drug
Administration is expected to vastly
expand the availability of cheap home
tests that many experts have advocated since the early days of the
outbreak. The announcement late last
month comes as U.S. testing numbers
continue to slide, even as the number
of new coronavirus infections is rising
The FDA said Abbott’s BinaxNow
and Quidel’s QuickVue tests can now
be sold without a prescription. Both
tests were first OK’d last year but
came with conditions that limited
their use, including prescription
requirements and instructions that
they only be used in people with
The agency authorized an over-
the-counter COVID-19 test from an
Australian company in December but
it is still not widely available.
Users will only need to perform a
minimally invasive nasal swab, not
the deeper nasal swaps common in
some PCR tests. The sample is then
inserted into a test strip with results
usually available in 10 to 20 minutes.
Quidel’s test is designed for self-
collected nasal swabs for people 14
or older and for adult-collected specimens of children 2 years and up.
Rapid antigen tests provide the
advantage of lower costs, fewer
supplies and speed than molecular
PCR tests, which take one to two days
for laboratory processing. PCR tests
can detect lower levels of replicating
virus, but antigen tests are intended to
be accurate at detecting virus when a
person is actively sick and most likely
The FDA has discussed the limitations of the accuracy of some rapid
antigen tests and noted that they may
be subject to false positive results
— especially if there is not a lot of
active virus in a specific community
or if they are performed incorrectly.
Proponents of rapid antigen tests
point out the benefit of more people
being able to identify when they are
most contagious so they know to
immediately isolate and not pass on
the virus. Confirmation testing is still
“The test performs at greater than
95% accuracy, and that’s the kind
of level that we need to have the
confidence to return to all the many
things that we love to do,” said Mary
Rodgers, principal scientist at Abbott.
Abbott said its test would be
priced in the “single digits” per test
and should be available in “coming
weeks” at pharmacies, supermarkets
and other chains. The company can
produce about 50 million tests per
month. Quidel did not disclose pricing for its test.
Both companies said they would
sell their tests in two packs. Repeat
testing is important to reduce chances
of false results. Both tests can be used
by adults to test children 2 years and
Frequent self-testing is considered key to help reopen
schools, universities and offices as vaccinations ramp up.
Dr. Michael Mina of Harvard said the expanded testing options would be critical as new virus variants spread and researchers study how long protection from vaccines lasts.
“Vaccines are incredibly important
but they are not the end-all, be-all
to this pandemic,” Mina said. “We
need other tools in our arsenal and
the widespread availability and rapid
scale up of tests for people to use in
the privacy of their homes is going to
be an extraordinary gain.” repeatedly at home.
The FDA has approved the BinaxNOW rapid COVID-19
test made by Abbott Laboratories, in Tacoma, WA, for sale
without a prescription for consumers to test themselves
Also last month, federal officials announced a pilot testing program to study use of rapid home testing to slow infections in U.S. communities. The program will provide free home tests to as many as 160,000 people in two counties in North Carolina and Tennessee.