03:09 GMT24 January 2021
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    The US Food and Drug Administration (FDA) on Monday alerted patients and health care providers that a COVID-19 test manufactured by the company Curative may produce false-negative results, which can lead to “unintended adverse events,” including increased risk of the spread of COVID-19.

    On Monday, Brian Monahan, the Capitol physician, commented on the FDA’s warning in a memo obtained 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 Curative test has been used to screen House of Representatives and Senate members, with the Office of the Attending Physician offering the test to lawmakers, staff and reporters since at least November. At the time, congressional leaders established a mass testing program to prevent members, who often travel across the country, from unknowingly spreading the virus to others.

    In his memo, Monahan noted that the risk of false negatives was not unique to the Curative test, which he called "the most accurate available." 

    Concerns over the accuracy of the Curative test came as COVID-19 fears increased over the weekend due to lawmakers congregating in the Capitol for the swearing-in of hundreds of members. 

    More than 50 lawmakers have revealed positive COVID-19 test results to the public, including Rep. Kay Granger (R-TX), who got the result from Curative test at the Capitol over the weekend, Politico reported.

    There has also been concern among lawmakers and senior aides that several quarantining House members have been permitted to participate in this week’s proceedings from behind a plexiglass barrier.

    “We have taken 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 (D-MD) reassured reporters Tuesday, Politico reported.

    According to the FDA, the Curative test should not be used as the only means for determining treatment or other patient-management decisions.

    “Consider retesting your patients using a different test if you suspect an inaccurate result was given recently by the Curative SARS-CoV-2 test,” the FDA alert reads. “If testing was performed more than two weeks ago, and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.”

    In a statement to Politico, Curative CEO Fred Turner revealed that the company is aware of the FDA safety alert.

    “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,” Turner said.

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