LA, Congress take divergent paths after COVID test warning

LA, Congress take divergent paths after COVID test warning

SeattlePI.com

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LOS ANGELES (AP) — The nation’s second-largest city said it will keep using a coronavirus test that federal regulators warned may produce false results while Congress, which has used the same test, is seeking an alternative.

The different responses Thursday followed a Food and Drug Administration alert to patients and health care providers that Curative’s test, which is used in some of the nation's largest cities, could particularly produce false negatives. Those faulty results pose the biggest risk from a health perspective because people who are erroneously told they don’t have the virus can unknowingly spread it.

The warning comes as California copes with its worst surge of the pandemic and some of the highest levels of COVID-19 in the country. Hospitals in Los Angeles and across the southern half of the state are overwhelmed with patients, oxygen used for treatment is running low and ambulances sometimes wait hours to unload patients.

Curative, a California startup company, said in a statement it was working with the FDA to address concerns and would provide additional data to address test limitations and precautions highlighted by the agency. The company said its test was the most clinically sensitive test available at scale and its performance had not changed.

The FDA offered no information on what triggered the warning Monday, but it appeared to be about the test's accuracy for people who don't exhibit symptoms of COVID-19, such as fever, sore throat and fatigue.

Dr. Clemens Hong, who oversees coronavirus testing for Los Angeles County, said the company’s initial emergency use authorization from the FDA was based on a limited study of subjects with coronavirus symptoms. The company later performed a clinical study involving asymptomatic subjects but the FDA balked at approving use for people without...

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