In a May 14 public notice, the agency said that it’s still evaluating data from 15 adverse event reports suggesting the tests were producing false negatives. The tests can still be used to correctly identify positive cases in minutes, but negative results may need to be confirmed with a separate test, the FDA said.
The agency said no diagnostic test is 100 percent accurate because of possible human error, and it is looking into whether Abbott’s tests are producing false negatives because of the use of certain types of swabs or the type of reagent liquid it’s transferred in.
Abbott agreed to conduct a trial of the test using at least 150 people with confirmed COVID-19 cases to see if the tests produce false negatives.
Read the FDA’s full news release here.
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