FDA Warns Rapid Coronavirus Test Touted By White House May Give False Negatives


The Food and Drug Administration warned Thursday a coronavirus test touted by the White House may provide false results.

The agency said the Abbott ID NOW point-of-care test, which was given emergency authorization by the FDA in March, may return false negatives in some cases where patients actually have the coronavirus. The FDA said it had received 15 reports that the device didn’t reflect accurate results.

“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue,” Tim Stenzel, director of the FDA’s office of in vitro diagnostics, said in a statement.“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.”

The agency noted it was sharing its concerns publicly “in the spirit of transparency,” clarifying that “no diagnostic test will be 100% accurate.”

President Donald Trump opens a box containing a 5-minute test for COVID-19 from Abbott Laboratories on March 30. 

More than 1.4 million people in the U.S. have been infected with the coronavirus and more than 85,000 have died. Cases have continued to climb, but President Donald Trump and other lawmakers have urged some regions to reopen in an effort to kickstart an economy devastated by the pandemic.

The FDA stressed Thursday that any patient tested for COVID-19 who was given negative results but had ongoing symptoms consistent with the virus should have their results confirmed by another test.

The Abbott device has been used at the White House to screen staff members and visitors and can provide rapid results. Trump himself trotted out the machine during a news conference, calling the results “highly accurate” and saying the device made the fight against infections a “whole new ballgame.”

But the White House has itself been rattled by the ongoing pandemic. Two staff members have tested positive for the virus in recent days — an aide to Vice President Mike Pence and a valet to the president — and one adviser said it had become “scary to go to work.”

Reuters notes Abbott Laboratories has already distributed more than 1.8 million ID NOW tests around the country

A preliminary study reported earlier this week cast doubt on the efficacy of the Abbott device. A group of researchers from New York University said the machine missed between a third to nearly half of positive cases caught on a competing device, although the study has not yet been peer-reviewed.

Abbott has rejected those findings and sought to soothe investors on Thursday evening.

“It’s unclear if the samples were tested correctly in this study,” the company told The Washington Post in a statement. “This rate has been previously shared with the FDA. In communications with the users of the test, it is performing as expected.”

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