WASHINGTON (Reuters) - A top Trump administration official said on Friday the government still has confidence in Abbott Laboratories’ ABT.N speedy coronavirus test used at the White House, which regulators have warned could deliver inaccurate results.
“We got 15 adverse event reports ... and so we, at the FDA and the manufacturer, are going to be studying and tracing those down,” Health and Human Services Secretary Alex Azar told Fox Business Network. “We’ve got to get to the bottom of it, but we still have confidence in the test or we wouldn’t have it on the market.”
The Food and Drug Administration said on Thursday early data about the Abbott ID Now test suggested it could produce potentially inaccurate results, particularly by failing to detect people who have the illness.
Earlier this week, New York University researchers said the tests could be missing a third to nearly half of positive cases. The study was not peer reviewed.
Abbott said in a statement on Thursday that the number of patients studied by NYU was small and that some studies of its test had used it in ways it was not intended to be.
“When our customers run it as intended, our test is performing excellently,” said Philip Ginsburg, a senior medical director in Abbott’s rapid diagnostics unit.
Other studies showed a higher rate of accuracy for the test. A study done in a testing clinic in Detroit said the ID NOW test was accurate 98% of the time. Another out of Washington state said the test found positive cases more than 90% of the time.
Reporting by Tim Ahmann, Editing by Franklin Paul and Cynthia Osterman
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