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FDA Warns About Accuracy of Popular Virus Test

Abbott Labs is pushing back but will offer more guidance to clinicians handling the tests
By Jenn Gidman,  Newser Staff
Posted May 15, 2020 10:29 AM CDT

(Newser) – More than 235,000 coronavirus tests by Abbott Laboratories have been distributed around the US in the hopes of better categorizing who's been infected where, per Axios. But the Food and Drug Administration is now issuing a warning about those tests, saying that in some cases they may be spitting out false negatives that make people think they don't have COVID-19 when they actually do. NPR cites a Cleveland Clinic study from last month that indicated the Abbott ID NOW test, which can produce results in less than 15 minutes, had a false-negative rate of nearly 15%. Dr. Gary Procop, who leads coronavirus testing at the clinic, said at the time "that's not too good," noting that a test should be at least 95% reliable. A second study released this week by NYU's Langone Health showed the test missed nearly 50% of positive virus cases when using dry nasal swabs, per NPR.

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However, that study hasn't been peer reviewed, and Abbott is pushing back on it, noting its small size and the fact that other studies have shown its tests to be reliable and accurate, per NBC. "We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue," an FDA rep said, per a Thursday release, adding that "negative results may need to be confirmed with a high-sensitivity authorized molecular test." He noted, however, that the test can still be used to "correctly identify many positive cases in minutes." Even though Abbott defends the accuracy of its tests, it tells NBC it will offer more guidance to medical staff dealing with the test samples, including how to collect and handle them. (Read more coronavirus stories.)

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