FDA warns Congress about Covid test that may give false results

The bipartisan Congressional Personalized Medicine Caucus aims to educate Congress and the public about the benefits of earlier detection, targeted treatment, and improved prevention strategies in personalized medicine. [Architect of the Capitol]

NBC News-On Monday night during the week in which most of the 535 lawmakers are expected to gather in one chamber to certify the Electoral College results, the Food and Drug Administration had a message for Congress — the tests available yield an alarmingly high rate of false negatives.

After a monthslong delay on Capitol Hill to implement Covid-19 testing for the members and staff, thousands of those who work in the building have become reliant on the system due to increased holiday travel and exposure.

But the new FDA warning questions the efficacy of tests administered by the start-up Curative just weeks after becoming readily available in November after a slew of positive cases among lawmakers.

“The FDA notice does not raise any doubts about the accuracy of a positive test result. The potential concern only relates to negative test results,” Dr. Brian P. Monahan, the lead Capitol Physician, wrote to House and Senate offices.

“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.”

For the first time since the pandemic began, almost the entire House gathered on the floor Sunday with less-than-ideal social distancing and mask wearing. Rep. Kay Granger, R-TX, was on the floor voting and mingling with members, and promptly tested positive for coronavirus the following day.

“We have urged distancing, that has not always occurred. But we continue to urge members to come, vote, leave, and not spend time on the floor, if they are not needed on the floor. That hasn’t always worked as well as we’d like and we continue to admonish members to observe that. And we will continue to do so,” Hoyer told reporters on a call Tuesday ahead of the certification.

Before this week, at least 60 lawmakers have tested positive for the virus, per an NBC News count, and on Wednesday, when both chambers of Congress will gavel in for a joint session that could last into Thursday, a majority of lawmakers will be in the same room at the same time.

“During the joint session, access to the Floor of the House will be limited to those Members who are scheduled to speak during the joint session,” according to guidance Tuesday night from the Capitol physician and the sergeant at arms.

Testing on Capitol Hill, free for those with a congressional ID, has been popular and heavily relied upon, particularly on Congressional travel days and in recent weeks due to the holidays.

“I am a bit alarmed that Fred Turner, the 25-year-old founder of Curative Inc., with no medical background was rewarded the contract for testing lawmakers, staff and the media in the U.S. Capitol,” one Republican Senate aide said. “I have been reliant on this service and captiously optimistic that it’s reliable.”

Curative, a Los Angeles-based startup co-founded by Turner, was originally created to detect sepsis — a deadly blood infection. Now, the company was awarded a contract to conduct testing on a third of the United States’ government.

The testing company has not yet responded to NBC News’ request for comment on the exact amount of tests administered and more information on the contract secured with Congress.

“I’m worried we’re going to see many more members get sick,” said one Democratic House aide. “We’ve already witnessed members ignoring the safety guidance since the 117th (Congress) started.”

“With tensions high and people in close quarters,” the staffer worries that Wednesday’s certification of Electoral College votes at the Capitol “could be its own superspreader event.”