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US allows 2 more over-the-counter COVID-19 home tests

Published: Apr. 1, 2021 at 11:09 AM CDT
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WASHINGTON (AP) — 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 Wednesday comes as U.S. testing numbers continue to slide, even as the number of new coronavirus infections is rising again.

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 symptoms.

The home tests allow users to collect a sample themselves with a nasal swab that is then inserted into a test strip. Results are usually available in 10 to 20 minutes. Most other COVID-19 tests require a swab sample taken by a health worker at a testing location.

The agency authorized an over-the-counter COVID-19 test from an Australian company in December but it is still not widely available.

Abbott said its test would sell in “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 considered crucial to reducing the chance of false results. Both tests can be used by adults to test children 2 years and older.

Frequent self-testing is considered key to help reopen schools, universities and offices as vaccinations ramp up.

Dr. Michael Mina of Harvard praised the announcement in an emailed statement saying they would help “make frequent rapid at-home testing more affordable and accessible to all Americans.” He added that frequent testing would remain important as virus variants spread and researchers study how long protection from vaccines lasts.

Last month, the FDA eased its standards for reviewing rapid screening tests, after months of criticism from Mina and other experts that they were delaying the introduction of increased testing.

Also on Wednesday, 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.

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Follow Matthew Perrone on Twitter: @AP_FDAwriter

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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