FDA Reviews Abbott’s Rapid Test for CCP Virus, Citing ‘Possible Accuracy Concerns’

FDA Reviews Abbott’s Rapid Test for CCP Virus, Citing ‘Possible Accuracy Concerns’
A new COVID-19 test kit developed by Abbott Labs in the Rose Garden of the White House in Washington on March 30, 2020. Win McNamee/Getty Images
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The U.S. Food and Drug Administration (FDA) on Thursday said that Abbott Laboratories’ point-of-care test, “Abbott ID NOW,” which has been widely used to diagnose COVID-19 in under 15 minutes, could potentially yield inaccurate results.

“Specifically, the test may return false negative results,” the FDA said in a release, citing preliminary data that the agency says it is now “evaluating.” A false negative result would mean that the test falsely cleared an individual of infection.