LA To Stick With COVID-19 Test FDA Calls Faulty

JAN. 10 UPDATE: On Sunday, the L.A. County Health Department issued a statement that read, in part:

"As a precaution, the LA County Department of Health Services (DHS) will discontinue the use of the Curative COVID-19 PCR tests at our County-supported pop-up testing sites. The change, which will take place this week, comes after a review of the data that prompted the recent U.S. Food and Drug Administration alert about the possibility of false negative results."

ORIGINAL STORY: The city and county of Los Angeles will stick with a COVID-19 test by the company Curative despite an FDA alert this week saying the test poses a “risk of false results, particularly false negative results.” The agency didn’t specify the false error rate.

Local officials pointed out that 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 upwards of 95% of COVID-19 cases.

San Dimas-based Curative has provided millions of tests for city and county sites throughout Los Angeles since last April.

The FDA did not say what triggered the alert; the information was the same the agency provided when it authorized the test for emergency use several months ago.

Curative said in a statement that its test is the most clinically sensitive one available and its performance has not changed since the FDA authorized it.

The FDA said in the alert that to reduce the risk of false negative results, Curative tests should only be given to people who have COVID-19 symptoms.

L.A. Mayor Eric Garcetti disagrees. He said yesterday that the city’s sites will continue to offer the tests to asymptomatic residents.

“This is something that has saved lives, will continue to save lives,” Garcetti said. “If we move away from it, I fear we would have a lot fewer people diagnosed, and even more spread.”

There is no issue with the test’s ability to detect positive cases, Garcetti noted. He said about 92,000 of the positive test results from the city’s program were from people without symptoms.

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