The Food and Drug Administration (FDA) is issuing an alert that a COVID-19 diagnostic test commonly used to test White House officials may be producing inaccurate results.
On Thursday, the FDA flagged the Abbott Labs’ ID NOW point-of-care test — which the FDA granted emergency use of in March. Over the last few weeks, the test garnered national attention due to its ability to produce coronavirus test results in 13 minutes or less.
The test has been used for multiple White House officials including President Donald Trump, who recently praised the test because of its rapid turnaround on results.
Our Update on ID NOW
— Abbott (@AbbottNews) May 14, 2020
ID NOW is the fastest molecular point-of-care rapid test available today and has been delivering reliable results when and where they're needed. (1/9) pic.twitter.com/QzrDLnG88K
Now, it is being reported that the test has likely missed more than 48% of potential positive cases.
According to a new study by New York University’s Langone Health, the Abbott Labs test “missed a third of the samples detected positive when using nasopharyngeal swabs in viral transport medium and more than 48 percent when using dry nasal swabs,” as NBC News reported.
On Wednesday, Abbott Labs responded, stating, “It’s unclear how the samples were tested.”
“The outcomes in this paper are inconsistent with any experience that we’ve had with this instrument,” the statement read.
It is our responsibility to provide healthcare providers and the public with accurate information, and that's why we're doing the following: (6/9)
— Abbott (@AbbottNews) May 14, 2020
The latest news comes several weeks after the FDA issued an emergency use authorization for the rapid coronavirus test back in March.
Dr. Tim Stenzel, head of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, has released a statement about the status of the current re-evaluation of the test.
“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue,” Stenzel said. “We will continue to study the data available and are working with the company to create additional mechanisms for studying the test.”
Stenzel added:
“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.”
However, Health and Human Services Secretary Alex Azar said on Friday there is still confidence in the test.
“We got 15 adverse event reports … and so we, at the FDA and the manufacturer, are going to be studying and tracing those down,” Azar, a top administration official, told Fox Business Network. “We’ve got to get to the bottom of it, but we still have confidence in the test or we wouldn’t have it on the market.”
As of Friday morning, there are more than 1.4 million known coronavirus cases in the United States and the death toll has surpassed 87,000.