FDA authorizes rapid, non-prescription COVID-19 tests
More Americans will soon be able to purchase over-the-counter rapid coronavirus tests without a prescription at their local pharmacy or retail store following the U.S. Food and Drug Administration’s authorization of two more at-home tests that are easy to buy and perform.
The FDA on Thursday authorized BinaxNOW, a COVID-19 antigen self-test by Abbott, a U.S. COVID-19 testing manufacturing company. It also authorized the Quick Vue test by Quidel, a diagnostic health care product manufacturer.
Neither requires a prescription.
Abbott says its COVID-19 antigen self-test will be available to individuals with or without symptoms.
"Together with vaccines, the BinaxNOW self-test will help Americans get back to doing what they want and need to do -- like going to work and school or seeing friends and family -- with greater confidence," said Robert Ford, Abbott’s president and chief executive officer.
Abbott’s rapid test initially required a health care provider to administer the swab and solution-based test kit, and then it was authorized for at-home use with a virtual proctor watching the process, which was included with the $25 fee. This new FDA authorization allows an individual to perform the test themselves, without a doctor’s prescription and at a lower cost.
An Abbott spokesperson told ABC News the tests are expected to be sold in packs of two and will cost under $10 dollars per test. The spokesperson also said the test should be available in the coming weeks.
Users will only need to perform a minimally invasive nasal swab, not the deeper nasal swaps common in some PCR tests and can expect results in about 15 minutes, accordiing to the company.
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 contagious.
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 encouraged.
"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. "We are prepared with our manufacturing to supply tens of million tests a month."
Quidel, in a press release said its test "provides results in agreement with PCR 83.5% of the time when positive and 99.2% when negative." The company did not indicate a timeline for the release of its tests.
The influx of new tests comes as the nation faces a downward trend in the daily administration of COVID-19 tests, with health care workers now focused on distributing vaccine shots. The daily national COVID-19 testing rate is just over 1 million a day, according to the Johns Hopkins Coronavirus Resource Center.
Public health experts argue that the low testing numbers are not where the nation needs to be to fully pull itself out of the pandemic, as the daily COVID-19 caseload creeps upward.
"The same people who are doing the testing are often the same ones doing the vaccinations," said Dr. Wafaa El-Sadr, professor of epidemiology and medicine at Columbia University Mailman School of Public Health. "And the attention to some of the issues around supply may affect the focus turning to vaccines rather than tests."
With just about 17% of Americans now fully vaccinated, coronavirus testing remains an important tool in tracking new cases and putting a halt to spread.
The FDA in March issued additional guidance for test developers seeking emergency use authorization of tests screening large groups of individuals for COVID-19 infections. It is guidance that could come in handy for employers and school administrators looking for protection from bouts of coronavirus infection.
"With the FDA’s authorization of multiple tests, the public can be assured these tests have met our scientific standards for emergency use authorization," said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. "As we’ve said all along, if it’s a good test, we’ll authorize it."
