FDA clears rapid, non-prescription COVID-19 testing

More Americans will soon be able to purchase over-the-counter rapid coronavirus tests without a prescription at their local drugstore or retail store after the US Food and Drug Administration clears two more easy-to-use home tests. buy and perform.

On Thursday, the FDA cleared BinaxNOW, a COVID-19 antigen self-test by Abbott, a U.S. COVID-19 test manufacturer. It also licensed the Quick Vue test from Quidel, a manufacturer of health diagnostics products.

Neither requires a prescription.

Abbott says its COVID-19 antigen self-test will be available to people with or without symptoms.

“Combined 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, president of Abbott. and CEO.

Abbott’s rapid test initially required a healthcare provider to administer the swab and solution-based test kit, and then it was cleared for home use with a virtual monitor monitoring the process, which was included with the $ 25 fee. This new FDA clearance allows an individual to perform the test themselves, without a medical prescription and at a lower cost.

An Abbott spokesperson told ABC News the tests are expected to be sold in sets of two and will cost less than $ 10 per test. The spokesperson also said the test is expected to be available in the coming weeks.

Users will only have to perform a minimally invasive nasal swab, not the deeper nasal swaps common in some PCR tests and can expect results in around 15 minutes, according to the company.

The Quidel test is designed for self-collected nasal swabs for people 14 years of age or older and for specimens collected by adults from children 2 years of age and older.

Rapid antigenic tests offer the advantage of reducing costs, supplies and speed than molecular PCR tests, which take one to two days to process in the laboratory. PCR tests can detect lower levels of the replicating virus, but antigenic tests are supposed to be accurate at detecting the virus when a person is actively sick and most likely contagious.

The FDA has discussed the limits on the accuracy of certain rapid antigenic tests and noted that they may be subject to false positive results – particularly if there are not many active viruses in a specific community or population. they are poorly executed. Advocates of rapid antigenic testing point to the interest of more people able to identify when they are most contagious so that they will know how to isolate immediately and not transmit the virus. Confirmatory testing is always encouraged.

“The test works with greater than 95% accuracy, and it’s the kind of level we need to have the confidence to go back to all of the many things we love to do,” said Mary Rodgers, senior scientist at Abbott. “We are ready with our manufacturing to deliver tens of millions of tests per month.”

Quidel, in a press release, said his test “delivers results in agreement with PCR 83.5% of the time when it is positive and 99.2% when it is negative.” The company has not given a timeline for the release of its tests.

The influx of new tests comes as the country faces a downward trend in the daily administration of COVID-19 tests, with healthcare workers now focusing on vaccine distribution. The national daily test rate for COVID-19 is just over one million per day, according to the Johns Hopkins Coronavirus Resource Center.

Public health experts say low numbers of tests are not where the nation needs to be to fully extricate itself from the pandemic, as the number of daily COVID-19 cases soars.

“The same people who do the tests are often the same who do the vaccinations,” said Dr. Wafaa El-Sadr, professor of epidemiology and medicine at Columbia University’s Mailman School of Public Health. “And the focus on some of the supply issues can affect the focus on vaccines rather than testing.

With just 17% of Americans fully vaccinated, coronavirus testing remains an important tool for tracking new cases and halting the spread.

In March, the FDA issued additional guidance for test developers seeking authorization for emergency use of tests to screen large groups of individuals for COVID-19 infections. These are tips that may be helpful for employers and school administrators looking for protection against episodes of coronavirus infection.

“With the clearance of several tests by the FDA, the public can be assured that these tests have met our scientific standards for emergency use authorization,” said Dr. Jeff Shuren, director of the Center for Devices and Radiological Health from the FDA. “As we’ve always said, if it’s a good test, we’ll allow it.”