FDA warns of accuracy concerns with Abbott’s rapid coronavirus test

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WASHINGTON, May 15: The US Food and Drug Administration (FDA) alerted the public on Thursday to “early data that suggest inaccurate results” from using the Abbott ID Now rapid coronavirus test.

“Today, the US Food and Drug Administration is alerting the public to early data that suggest potential inaccurate results from using the Abbott ID NOW point-of-care test to diagnose Covid-19. Specifically, the test may return false negative results,” the FDA said in a statement.

It added that it is “sharing early information available about potential inaccurate results in the spirit of transparency.” “The agency has been working with Abbott to analyze the information gathered to date and has worked with the company on a customer notification letter to alert users that any negative test results that are not consistent with a patient’s clinical signs and symptoms or necessary for patient management should be confirmed with another test,” it noted.

It indicated that the “FDA has received 15 adverse event reports about the Abbott ID NOW device that suggest some users are receiving inaccurate negative results. The agency is reviewing these reports.”
It continued that “moving forward, Abbott has agreed to conduct post-market studies for the ID NOW device that each will include at least 150 COVID-19 positive patients in a variety of clinical settings.”
The FDA affirmed it will “continue to review interim data on an ongoing basis.”

Meanwhile, the World Health Organization (WHO) Dr. Maria Van Kerkhove told CNN “we’ve seen the global community come together. Manufacturers, scientists, leaders, to accelerate the development of a vaccine.”
“Everybody wants to know exactly how long that’s going to take. We can’t give an answer to that because it takes time to do these studies, these clinical trials to see if it’s safe and effective,” she said.
She added “we need to ensure that there’s access to that to everyone on the planet. And so this virus will be with us. We need to find a way to get to that steady state where we can suppress transmission enough, get back to our lives, to get back to living our daily lives.” (KUNA)

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