Matthew Herper writes in STAT that a test for the novel coronavirus that was unveiled by President Trump on the White House lawn and has already been used hundreds of thousands of times can falsely produce negative results in patients who are infected, according to clinicians and laboratory experts.
The 13-minute test, developed by Abbott Laboratories, a major U.S. health care and medical device company, usually still works properly, the company and clinicians say. But Abbott’s initial guidance on how to administer the test — guidance approved by the Food and Drug Administration — could lead to an unspecified number of false negative results. Abbott says changing how samples are collected should fix the problem.
The test “performed equivalent to the other platforms with patients that had high and moderate loads of virus,” said Alan Wells, a pathologist who directs the clinical laboratories at the University of Pittsburgh Medical Center. “However, with lower loads of virus, a large fraction of these patients were not detected as positive.” Wells ran a validation of the test compared with stored samples that had been tested on other platforms.