HHS working to replace potentially faulty Covid tests used by Congress

“What I saw yesterday horrified me as an American, but also as a public health professional,” Becker said. “Was there a risk of potential exposure yesterday? Absolutely.”

FDA earlier this week raised concern about the performance of a lab-based coronavirus test made by Curative and used by several major cities as well as Congress, saying it carries a “risk of false results, particularly false negative results.” The health agency encouraged health providers to limit use of the test to people who have had Covid symptoms for 14 days or less.

“We are working with the office of the congressional physician very closely to provide high-throughput, very sensitive testing that would not be dependent on Curative,” Giroir said Thursday to reporters. “We are very confident that that will be in place to handle all the issues around inauguration.”

It is unclear what type of coronavirus tests will be provided to the Office of the Attending Physician. “We have a number of choices and we’re exercising several of them,” Giroir said. “I am highly confident we can meet the security needs of Congress.”

The Office of the Attending Physician did not respond to repeated phone calls asking about the HHS offer. Brian Monahan, the Capitol physician, said Monday in a memo first obtained by POLITICO that his office “will keep the Capitol community informed regarding any changes necessary in our Coronavirus testing process.”

Giroir said he personally reviewed the FDA safety communication about Curative’s test before it was published, adding that he agreed with the agency’s recommendations. The regulatory agency cautioned that negative results from a Curative test “does not rule out” a Covid infection, and told health care providers to not use it as the “sole basis for treatment or patient management decisions.”

“I would be urge that it be used on label,” Giroir said. “We are always open to new data from Curative to show that they can be effective in other situations.”

Source:Politico