WASHINGTON (AP) – U.S. health officials have approved two more prescription useless COVID-19 tests that can be used at home for fast results.
The move by the Food and Drug Administration is expected to significantly expand the availability of low-cost home tests, which many experts advocate from the first days of the outbreak. The announcement comes late Wednesday evening as US test numbers continue to slide, even as new coronavirus infections rise again.
The FDA said Abbott’s BinaxNow and Quidel QuickVue tests could now be sold without a prescription. Both tests were good at first last year, but conditions were introduced that limited their use, including prescription requirements and instructions that they could only be used by people with symptoms.
Home tests allow users to collect a sample with a nasal swab, which is then inserted into the sample. Results are usually available in 10 to 20 minutes. Most other COVID-19 tests require a test sample taken by a healthcare professional at the test site.
The agency licensed the COVID-19 patent test from an Australian company in December, but it is not yet widely available.
Abbott said the test would be “one-digit” for a single test, and would be available “in the coming weeks” in pharmacies, supermarkets and other chains. The company can produce about 50 million tests a month. Quidel did not disclose the prices of its tests.
Both companies said they would sell their tests in two boxes. Duplicate testing is considered to be possible to reduce the possibility of false results. Both tests can be used by adults to test children 2 years and older.
Frequent self-testing is considered important to help reopen schools, universities, and offices as vaccines rise.
Dr. Michael Mina of Harvard said enhanced testing would be possible as new versions of the virus spread, and researchers were studying how effective vaccine protection was.
“Vaccines are incredibly powerful, but they are not the final ones for this epidemic,” Mina said. “We need other tools in our arsenal, a wide range of tests, a fast scale for people to use in the privacy of their own homes, and it will be an extraordinary benefit.”
Last month, the FDA eased its standards for reviewing rapid screening tests following criticism from Mina and other experts months later that they were delaying the introduction of increased testing.
Also Wednesday, federal officials announced a pilot program to study the use of rapid home testing to slow infections in U.S. communities. The program will provide free home tests to approximately 160,000 people in the two states of North Carolina and Tennessee.
Follow Matthew Perron on Twitter at @AP_FDAwriter
The Associated Press Department of Health and Science receives support from the Department of Science Education at Howard Hughes Medical Institute. The AP is solely responsible for all content.