COVID-19 test used by Congress could give false results, FDA warns

The COVID-19 test being used in the U.S. Capitol could be producing false negative results, according to the Food and Drug Administration (FDA).

The test, manufactured by Curative, has been offered for lawmakers, staff and reporters since November, following an order from the D.C. mayor requiring people traveling to the city to obtain a test. 

But the accuracy of that test is now in question after the FDA on Monday alerted patients and health care providers of the risk of false results, “particularly false negative results,” with the Curative COVID-19 test. 

In a memo sent Monday and first reported by Politico, the Office of the Attending Physician said it was “monitoring” the FDA’s warning about the test, which is currently used at the Capitol under medical supervision.

Brian Monahan, the Capitol physician, noted the test is “the most accurate available” but that there is always a risk for false negatives, especially in people who appear asymptomatic, which he noted “is 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 wrote.

The possibility of false negative test results could complicate efforts to stop coronavirus outbreaks in Congress, as well as in the broader community.

At least 49 members of Congress or lawmakers-elect have tested positive for COVID-19 since March, while several others have tested positive for antibodies or had presumed cases.

Rep.-elect Luke Letlow (R-La.) died last week from COVID-19 complications at the age of 41, days before he was set to take office.

In a notice posted online, Monahan said the test is only for people without symptoms to verify their status. 

“It is not intended as a resource for people who are currently symptomatic to obtain testing,” because current guidance says ill people are prohibited from the grounds of the Capitol complex, the notice said.  

People who are exhibiting symptoms are encouraged to make use of community-based testing.

But according to the FDA, Curative’s test is only authorized for symptomatic individuals within the first 14 days. 

The FDA also said the test should not be used as the only data point for treatment or patient-management decisions. 

“A negative result does not exclude the possibility of COVID-19,” the agency said.

In a statement, Curative CEO Fred Turner said the company is aware of the safety notice and is working with the FDA.

“We are confident in our data and we are working with the FDA closely on the matter. Testing sensitivity and accuracy on behalf of our patients is at the heart of our work. Curative will be providing additional updates and information soon,” Turner said.

Members of Congress are advised to be tested for COVID-19 upon arrival in Washington, but can still go about their regular business while awaiting their results if they don’t have symptoms or any known exposure to the virus. The Capitol’s testing system provides results within one day at the most and often in a matter of hours.

The expanded testing system was put into place after many lawmakers — who regularly have to travel back and forth between their districts all over the country and Washington — spent months calling for one.

Cristina Marcos contributed