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FDA warns COVID-19 test used by Congress is ‘particularly’ prone to false negative results

The Food and Drug Administration this week alerted health care providers and patients that a COVID-19 diagnostic test made by Curative poses a “risk of false results, particularly false negative results,” Politico reports.

The House and Senate screen members, staff, and reporters covering Capitol Hill with the Curative test, so when Congress is in session that means dozens, sometimes even hundreds of people, use it to determine if they’re infected. The FDA is now saying the test 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, per Politico. Read more at Politico.

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