A rapid 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.
in testing for the coronavirus, known as SARS-CoV-2. Much of the problem has been blamed on issues with how samples for the main laboratory tests are collected.
But the FDA cleared the test to be used in another way: The swabs could be put in a liquid solution — known as "viral transport media" — and tested, which is the standard way for processing many other kinds of tests and usually allows samples to be stored longer. Wells, the pathologist, said that the University of Pittsburgh Medical Center is now not using the ID Now to rule out whether patients are carrying SARS-CoV-2, but will consider using the machine to identify patients to enroll in clinical trials. For testing surgery patients, it is using another testing machine, from Cepheid, that can return results in 45 minutes.
"I think the important point is all these assays have been emergency release by the FDA," Misialek said. "So they haven't gone through the traditional rigor of studies, and validations and certainly not extensive comparisons. But right here, at Newton-Wellesley and my colleagues across Partners, we haven't seen anything to date that worries us."
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