Brian Monahan, the Capitol doctor, acknowledged the FDA warning in a Monday memo obtained by POLITICO, which described the test as “the most accurate available” and noted that the risk of a false negative “is a problem for everyone coronavirus tests “.
“We look forward to receiving additional information from the FDA and our expert advisors in the coming days regarding any concerns about the continued use of this test for the Capitol community,” wrote Monahan in the memo on Monday.
False negative results are of particular concern because they can cause infected people to spread the virus without knowing it and delay treatment.
House and Senate leaders, along with the Capitol doctor, implemented a mass testing program in November, under pressure to better manage Covid-19 risk, as hundreds of members travel across the country weekly. Congressional officials initially resisted requests for tests on the building amid national shortages.
Questions about the accuracy of the Curative test come at a time when anxiety about the virus soared on Capitol this week, with hundreds of members forced to vote in person in plenary – instead of using proxy voting – and potentially create a super event broadcast on the opening day of the new Congress.
More than 50 lawmakers have publicly disclosed that they tested positive for the virus, including a member, Rep. Kay Granger (R-Texas), who tested positive after doing a dressing test at Capitol over the weekend.
The FDA says the test should not be used as the only data point for patient management or treatment decisions. Health care providers can reduce the risk of inaccurate results by limiting the use of the test to people who have had symptoms for 14 days or less, the agency added.
“Consider repeating your patients’ test using a different test if you suspect that an inaccurate result was recently given by the SARS-Cov-2 curative test,” the FDA warning states. “If the test was performed more than two weeks ago, and there is no reason to suspect the current SARS-CoV-2 infection, there is no need to test again.”
In recent days, high-ranking lawmakers and advisers have complained that House officials have allowed several quarantined lawmakers to participate in this week’s proceedings, protected by a plexiglass barrier. Several Republican Party lawmakers, meanwhile, continue to disregard public health measures, including wearing masks and adhering to physical distance.
“We take every precaution, we believe, to ensure the safety, not only of our members and the health of our members, but also of our staff,” House majority leader Steny Hoyer told reporters on Tuesday. , talking about the renewed efforts by Capitol officials to impose masks and social detachment.
Curative CEO Fred Turner told POLITICO that the company is aware of FDA safety communication and plans to provide more information soon.
“We are confident in our data and we are working with the FDA on the matter,” said Turner. “Testing sensitivity and accuracy on behalf of our patients is at the heart of our work.”
The Curative test, which must be analyzed in the laboratory, uses a technology – real-time polymerase chain reaction – generally considered the gold standard for the diagnosis of Covid-19. Testing experts consider PCR to be more accurate than rapid point of care tests, including the Abbott system in use at the White House. But PCR tests often take hours to produce results, rather than minutes for rapid tests.
The Capitol dressing tests are not the only ones that lawmakers have relied on in recent months; some were also tested in private locations in your districts before returning to Washington.