The Food and Drug Administration on Thursday night warned that users of the Abbott ID NOW point-of-care test to diagnose those with the Coronavirus - a test often used by the White House and touted by President Donald Trump - may not be accurate.
"Specifically, the test may return false negative results," the FDA said in a statement.
"We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue," the FDA added.
The Thursday night statement indicated the test was accurate for positive results on the Coronavirus, but that negative results might need to be confirmed with a second review.
In the spirit of transparency, FDA is alerting the public to early data suggesting potential inaccurate results during the Abbott ID NOW point of care #COVID19 test, specifically false negative results. https://t.co/rayPkde8oy pic.twitter.com/15Rh4Y50YN
— U.S. FDA (@US_FDA) May 15, 2020
President Trump has often talked up the Abbott test as an indicator of how well the U.S. has responded to the virus threat.
"This is a five to 15-minute test," the President said on Monday about the Abbott test. "These tests are highly sophisticated -- very quick, very good. This is things that didn't even exist a short while ago."
"So we do have a great testing capability at the White House," Mr. Trump added.
The FDA statement came a day after researchers at New York University released a study which said the rapid test might miss as many as half of positive cases.
Abbott had questioned the accuracy of that NYU review.
🚨 FDA issues alert over COVID19 test used inside White House - warns of false negatives. I took this test today before I could get close enough to ask President Trump questions. Result was negative, but FDA says result may need to be confirmed https://t.co/6OD9AiQzpF pic.twitter.com/oRRyP851Zc
— Paula Reid (@PaulaReidCBS) May 15, 2020
President Trump has alternately trumpeted the growing testing capabilities in the U.S. - and bemoaned them as well.
"We have more cases than anybody in the world. But why? Because we do more testing," the President said during a stop in Pennsylvania on Thursday.
"When you test, you have a case. When you test, you find something is wrong with people. If we didn't do any testing we would have very few cases. They (the press) don't want to write that. It's common sense," Mr. Trump said.
Cox Media Group