As COVID-19 testing numbers continue to slide in the United States, the Food and Drug Administration has authorized two at-home, over-the-counter COVID-19 tests that can get rapid results – without a prescription.
The FDA said Wednesday that Abbott’s BinaxNow and Quidel’s QuickVue COVID tests can be sold without a prescription.
The move by U.S. health regulators is likely to vastly expand the availability of cheap home tests that many experts have advocated since the early days of the outbreak, which comes as testing numbers are falling, but the number of new infections is rising once more.
"Screening testing, especially with the over-the-counter tests authorized today, is an important part of the country’s pandemic response — many schools, workplaces, communities, and other entities are setting up testing programs to quickly screen for COVID-19," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. "With the FDA’s authorization of multiple tests, the public can be assured these tests have met our scientific standards for emergency use authorization."
Both tests were first approved in 2020, 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, and 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 Australian company Ellume in December but it is still not widely available.
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 older.
Frequent self-testing is considered key to help reopen schools, universities and offices as vaccinations ramp up.
Harvard epidemiologist Dr. Michael Mina 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," Dr. Mina, a champion of widespread rapid testing, 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."
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.
The Associated Press contributed to this report.