The COVID-19 tests used by hundreds of senators, representatives, staff, and reporters on Capitol Hill every day has a “risk of false results, particularly false negative results,” according to the Food and Drug Administration.
In a Monday warning to patients and healthcare providers, the FDA alerted that Curative’s real-time RT-PCR test yielding false positives could lead to “delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended consequences.”
Curative’s rapid test is offered to those on Capitol Hill by Congress’s Office of the Attending Physician, according to Politico.
Brian Monahan, the Capitol’s attending physician, said in a memo obtained by the outlet that Curative’s test was “the most accurate available,” highlighting that potential false negatives are “a problem for all coronavirus tests.”
“We expect to have additional information in the coming days from the FDA and our expert consultants with regard to any concerns about the ongoing use of this test for the Capitol community,” Monahan added.
At the risk of garnering negative media attention amid nationwide testing shortages, lawmakers were slow to implement a testing regimen within Congress. House Speaker Nancy Pelosi introduced mask mandates for congressional committees and the House floor in July, but it wasn’t until October that Senate Democrats introduced a resolution that would require mask wearing in the Senate and a “robust testing regime” for the Capitol complex. The Capitol Hill complex didn’t begin a widespread testing program with rapid COVID-19 tests until November.
That resolution was introduced after more than 100 Capitol Hill staffers, more than a dozen House lawmakers, and a half-dozen senators contracted the virus.
Since then, more than 50 lawmakers have tested positive for the virus, according to Politico.
“To reduce the risk of false negative results, it is important to perform the test in accordance with its authorization and as described in the authorized labeling,” the FDA urged. “When the test is not performed in accordance with its authorization or as described in the authorized labeling, there is a greater risk that the results of the test may not be accurate.”
Curative CEO Fred Turner said that the company was aware of the FDA warning and was “working with the FDA closely on the matter.”
“Testing sensitivity and accuracy on behalf of our patients is at the heart of our work,” Turner added.
The Washington Examiner reached out to the FDA for further comment.
