FDA authorizes at-home COVID-19 self-test

Reporter: Veronica Marshall
Published: Updated:
A new COVID-19 at-home self-test will hit stores soon. (CREDIT: WINK News)

At-home COVID-19 testing is now authorized by the FDA.

The tests can be purchased without a prescription.

Doctors call this a game-changer.

Tourism, leisure and hospitality are the big three industries in Southwest Florida that took a hit when the pandemic first started and people were told they were safer at home.

“There’s no question that economic activity went down, it went down significantly,” said Dr. Victor Claar, an economist with Florida Gulf Coast University. “It especially went down in places like dining out, if you look at the numbers, and you plot the time series of how things like restaurant sales changed during the period, they fell off, way off.”

But now, the FDA has authorized two rapid over-the-counter at-home COVID tests which could keep businesses in gear.

“Removing the need for doctors, and it’s removing the need for extra costs,” said Dr. Michael Mina, an assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health.

Dr. Mary Rodgers, the principal scientist at Abbott Labs, said there have been over 200 million BinaxNow antigen tests have been performed.

“And we have excellent detection and sensitivity with this test,” Rodgers said. “This technology has been used with less than .01% complaints filed on the results. And it’s been effective in preventing new transmissions at schools and workplaces since August.”

Rodgers created one of the tests.

“I’m a mom. And I’m personally excited about the convenience factor of being able to bring my kids, put them at the kitchen table and do a test in 15 minutes so that we can go back to doing all the many things that we love,” she said.

These paper test strips can save lives.

“That alone might be enough to ensure that outbreaks don’t grow, and when an outbreak does start – it fizzles out very fast,” Mina said. “That means when an outbreak starts in a school or a nursing home, or wherever it might be in the future, we don’t have to close things down. We don’t have to take extraordinary measures in order to prevent the spread of new variants.”

The rapid antigen self-tests can detect variants and work on asymptomatic people as well. The tests should make it to store shelves in the next few weeks.

In a statement, the FDA said screening tests is an important response to the pandemic.

“With the FDA’s authorization of multiple tests, the public can be assured these tests have met our scientific standards for emergency use authorization. As we’ve said all along if it’s a good test, we’ll authorize it,” the FDA said.


FDA’s release on the new rapid at home OTC tests


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