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FDA Warns COVID-19 Test Commonly Used In LA Is Faulty

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The FDA issued an alert this week saying the COVID-19 test made by the California company Curative poses a “risk of false results, particularly false negative results.” The agency didn’t specify the false error rate.

Curative has provided tens of thousands of tests for city and county sites throughout Los Angeles since last April.

The FDA also said swabbing the nose or cheek "must be directly observed and directed … by a trained healthcare worker." Currently at city of L.A. testing sites, patients are given instructions and told to swab themselves.

In a statement, Curative quoted Dr. Brian Monahan, Congress’s attending physician, as calling the company's test “the most accurate available.” Curative said Monahan issued a memo on Monday in which he said false negatives are “a problem for all coronavirus tests.”

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The L.A. County Department of Health Services, which uses Curative tests at some of its sites, echoed Monahan’s assertion, saying in a statement that tests of the same type face “similar issues” with false negatives.

Curative said the FDA was aware of the test’s “limitations” when it authorized it for emergency use. The company said the test’s performance has not changed, and that it’s working with the FDA “to address their concerns and these limitations.”

The county encourages people who think they may have been exposed to the virus to quarantine for two weeks even if they test negative.

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