The Food and Drug Administration issued a warning about the reliability of the widely used Abbott Laboratories test that has been touted by the White House, NPR reports.
Trump has repeatedly promoted the Abbott test because it produces results quickly while most other tests have to be sent to a lab for processing.
Trump hyped the test during a news conference last month, calling it a “whole new ball game.”
But on Thursday, the FDA issued an alert “in the spirit of transparency,” reporting that it is investigating why the test produces so many false negatives.
"We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue," said Dr. Tim Stenzel, director of the FDA's Office of In Vitro Diagnostics 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."
Study finds test missed half of positives:
The alert came after researchers found that the test missed about half of positive cases.
As many as 15-20 of every 100 tests may produce falsely negative results, the study found.
"So that means if you had 100 patients that were positive, 15% of those patients would be falsely called negative. They'd be told that they're negative for COVID when they're really positive," Dr. Gary Procop, who led the research at the Cleveland Clinic, told NPR.
Abbott refutes study:
"ID NOW performs as expected and we have confidence in the performance of the test," Abbott said in a statement.
The company said any problems may be related to how samples are being stored before they are tested.
"When a direct swab is used, the test is performing as expected,” the company said.