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.

Leave a comment

Your email address will not be published. Required fields are marked *