Los Angles, Congress take divergent paths after COVID test warning

LOS ANGELES (AP) — Los Angeles will continue 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 at least three 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, 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 available at scale and its performance had not changed.

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

Dr. Clemens Hong, who oversees Los Angeles County’s coronavirus testing, said the FDA’s emergency use authorization was based on a Curative study of subjects with coronavirus symptoms. The company later studied the test on subjects without symptoms but the FDA balked at approving it for asymptomatic use.

Admiral Brett Giroir, the Trump administration’s top testing official, said Thursday that his Department of Health and Human Services is working with the congressional physician to find an alternative test for use on Capitol Hill.

No test is 100% accurate and even the most sensitive are expected to deliver a small percentage of false results. Most of the molecular tests authorized by the FDA, including the Curative test, are expected to catch upward of 95% of COVID-19 cases. ...