LA County Drops Curative COVID Test After FDA Alert on Accuracy

LA County Drops Curative COVID Test After FDA Alert on Accuracy

Los Angeles County officials announced Sunday they will no longer use Curative's COVID-19 tests at the county's pop-up testing sites after federal regulators issued an alert over its accuracy.

The move will impact a small number of county-run testing locations, said the L.A. startup's CEO Fred Turner. Curative tests will be replaced with tests from Fulgent Genetics, a Temple City-based lab.

The change will not affect the 10 testing sites supported by the city of L.A., including one at Dodger Stadium. Curative will continue to offer its oral swab test that patients can self-administer from inside their cars.

Last week, the U.S. Food and Drug Administration warned of that test's "risk of false results, particularly false negative results."

An FDA spokesperson confirmed to dot.LA that new information prompted the organization to issue the advisory but she would not elaborate. The FDA will continue to review how the test performs for both symptomatic and asymptomatic individuals.

Omai Garner, the director of clinical microbiology at UCLA, said these warnings are often released in response to complaints.

The announcement raises broader questions about the types of tests administered by counties across the nation, Garner said. If RT-PCR nasal tests are 100% sensitive, he said, oral fluid tests like Curative's are about 80% sensitive.

"They have a good test," Garner said. "The challenge is that oral fluid itself is probably not a good source, especially in the asymptomatic patient."

He added: "This to me is part of a much larger problem than just sending samples to one laboratory."

Subscribe to our newsletter to catch every headline.