FDA warns about risk of 'false negative results' in COVID-19 test used by Congress

The Food and Drug Administration this week alerted health care providers and patients about a COVID-19 diagnostic test made by Curative, warning "of the risk of false results, particularly false negative results."

The House and Senate screen members, staff, and reporters covering Capitol Hill with the Curative test, Politico reports, so when Congress is in session that means dozens, sometimes even hundreds of people, use it to determine if they're infected. The FDA highlighted "important information" regarding the test's use, which is described in its authorized label, including that it should not be used as the only data point "for treatment or patient-management decisions" and suggested limiting its use for people displaying symptoms for 14 days or less.

Rear Adm. Brian Monahan, the Capitol physician, acknowledged the warning in a Monday memo obtained by Politico, but said Curative's test is "the most accurate available" and false results are a risk faced by all coronavirus tests. "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," the memo reads. Read more at Politico. Tim O'Donnell

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Editor's note: This story has been updated to more accurately reflect the FDA's warning.