The FDA said adverse reports and some scientific studies call into question the accuracy of the Abbott ID NOW test, which receivedFDA emergency use authorization in March. But the agency also cautioned the alert was being made only “in the spirit of transparency” and no definitive statements about the test could be made yet.
“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue,” said Dr. Tim Stenzel of the FDA’s Center for Devices and Radiological Health. “We will continue to study the data available and are working with the company to create additional mechanisms for studying the test.
“This test can still be used and can correctly identify many positive cases in minutes. Negative results may need to be confirmed with a high-sensitivity authorized molecular test.”
A point-of-care test is a test like this one is performed where the patient is located. It usually brings quicker results than a testing format requiring sending bloodwork or specimens to medical laboratories. The Associated Press reports that the Abbott device has been used at the White House.
Abbott’s website said that theID Now test could give results as quickly as five minutes, allowing for quicker treatment, more testing and less tension in the wait for results.
There have been 15 “adverse event” reports, the FDA said, and “suggest some users are receiving inaccurate negative results.”
But these reports can come from any part of the healthcare field, from hospital to doctor to nurse to patient with varying degrees of accuracy.
In the FDA’s words, they “can be incomplete, inaccurate, or unverified, so agency staff must meticulously comb through the reports to identify crucial data to support any signals or patterns about device use.”
As for the studies that “have identified accuracy issues” with Abbott’s test, the FDA said it’s looking at whether the swabs or the method of moving the patient’s specimen could have caused those problems. The studies aren’t entirely unimpeachable either, hampered by limited sample size or human error on the use of Abbott’s test.
AnNew York Universiity study that came out Tuesdaysaid ID NOW whiffed on a third of the swab samples. The FDA didn’t name the NYU study, but Abbott did in its response that posted Thursday.
“We’re seeing studies being conducted to understand the role of ID NOW in ways that it was not designed to be used. In particular, the NYU study results are not consistent with other studies.”
But Abbott did say, going forward, “Negative results should be presumed negative, but if inconsistent with clinical signs and symptoms or necessary for patient management, should be tested with an alternative...
“We are also reinforcing proper sample collection and handling instructions.”
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