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FDA Warns of Possible False Results From Some COVID-19 Tests

By Jack Phillips

The U.S. Food and Drug Administration (FDA) on March 1 said that three rapid COVID-19 tests shouldn’t be used because of the potential for producing false results.

The FDA told people to avoid using the Celltrion DiaTrust COVID-19 Ag Rapid Test, the SD Biosensor Inc. STANDARD Q COVID-19 Ag Home Test, and the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing).

“The FDA is concerned about the risk of false results when using” those tests, according to the agency. These tests have “not been authorized, cleared or approved by the FDA for distribution or use in the United States,” the agency said.

All three tests work via nasal swab, the agency added. It recommended that health care providers have patients submit to new testing if they’ve used any of the three tests in the past two weeks…

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