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FDA Warns of False Negatives From Type of Test Offered in Bay Area

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COVID-19 tests by California startup Curative have a high rate of false negatives, according to a statement released earlier this week by the Food and Drug Administration.

The company runs dozens of self-administered testing sites across the Bay Area and has even partnered with local government entities such as Marin County and the Alameda County Office of Education.

Curative also launched a pop-up testing site Friday morning in Sonoma County.

D’Arcy Richardson, the county director of nursing for COVID response, defended the use of Curative’s oral tests and said they are still helpful because testing remains in high demand.

“No test is perfect,” Richardson said, “But this test really can be a useful option for people who either can't tolerate a nasal swab, for some reason, or choose not to have a nasal swab.”

Richardson also pointed out that the FDA’s warning is more about “how you use the test, not the test itself.”

The FDA says that to reduce the risk of false negatives, Curative tests should be used by people displaying actual symptoms of COVID-19 and should be performed under observation by a trained health care worker, which Richardson says the county has been doing all along.

Curative did not respond to a request for comment.

Julie Chang

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