Story at a glance
- The polymerase chain reaction test, manufactured by Curative, has been made available to members, staff and reporters working on Capitol Hill since November.
- The accuracy of the test was called into question after the FDA took the step of alerting health care providers and patients that the test carries the “risk of false results, particularly false negative results.”
- The Office of the Attending Physician said it was monitoring the FDA’s warning, but said the test is “the most accurate available” and that the risk for a false negative result is a problem for all COVID-19 tests.
Congress is using a COVID-19 test that the Food and Drug Administration (FDA) now says may be subject to producing false negative results.
The polymerase chain reaction test, manufactured by Curative, has been made available to members, staff and reporters working on Capitol Hill since November, and hundreds of people are tested each day when Congress is in session.
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But on Monday, the accuracy of the test was called into question after the FDA took the step of alerting health care providers and patients that the test carries the “risk of false results, particularly false negative results.”
“Risks to a patient of a false negative result include: 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 adverse events,” the FDA said Monday.
In response, the Office of the Attending Physician said it was monitoring the FDA’s warning, but said the test is “the most accurate available” and that the risk for a false negative result is a problem for all COVID-19 tests.
“This is not unique to this test. It is a problem for all coronavirus tests,” Brian Monahan, the Capitol physician, said this “is a problem for all coronavirus tests” in a memo Monday first reported on by Politico.
“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 FDA said health care providers should consider retesting patients with a different COVID-19 test if they suspect the Curative test result was not accurate.
More than 50 members of Congress have publicly said that they tested positive for COVID-19 over the course of the pandemic.
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