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COVID-19

FDA issues alert about accuracy of Abbott rapid COVID-19 test

David Brancaccio, Nova Safo, and Alex Schroeder May 15, 2020
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For now, negative results from the Abbott test should be confirmed with another more sensitive test. Win McNamee/Getty Images
COVID-19

FDA issues alert about accuracy of Abbott rapid COVID-19 test

David Brancaccio, Nova Safo, and Alex Schroeder May 15, 2020
Heard on:
For now, negative results from the Abbott test should be confirmed with another more sensitive test. Win McNamee/Getty Images
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Public health experts say one key to managing the pandemic is frequent testing and retesting for COVID-19. But federal regulators have raised a question about the accuracy of a new test that produces rapid results.

As it happens, that Abbott Laboratories test is being used on those who work at the White House. Abbott stock was down 3% in pre-market trading on Friday.

“The concern is that it could be returning false negative results,” Marketplace’s Nova Safo said. “New York University researchers took a look and said earlier this week that the test was returning false negatives, that it was missing nearly half of all positive samples collected with dry nasal swabs.”

On Thursday the FDA issued an alert saying it’s looking into that finding. Abbott’s ID Now test is a rapid diagnostic tool that’s supposed to return results in a few minutes.

In the meantime, the FDA says negative results from the Abbott test should be confirmed with another more sensitive test, Safo told “Marketplace Morning Report” host David Brancaccio.

False negatives are not a new problem during this pandemic. When China was testing the population in Wuhan, there were also reports of a lot of false negative results there.

Abbott does dispute the NYU study. The company says other studies have shown its rapid diagnostic system gets better results than the other tests that are out there.

The FDA has approved dozens of emergency authorizations to get COVID-19 diagnostic supplies out to market, though others take longer to return results than the Abbott test does.

So far, according to the Centers for Disease Control and Prevention, more than 10 million viral tests have been conducted in the U.S., and 15% have come back positive.

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