After weeks of concerns about the accuracy of an Abbott (NYSE:ABT) rapid COVID-19 diagnostic test, the FDA last night issued a warning that the ID NOW test may return false-negative results.
Citing “early data,” the agency said it is “sharing early information … about potential inaccurate results in the spirit of transparency.”
A preliminary study released this week by researchers at New York University found that the test missed up to 48% of positive results. Researchers at the Cleveland Clinic reported in April that the ID NOW had a false-negative rate of 14.8%, according to a report by National Public Radio.
One issue is the treatment of specimens before they are placed in the ID NOW machine. Abbott advised customers on April 15 that placing specimens in liquid viral transport media before processing — stan…