LA County to stop using curative tests after FDA warns of false negatives

LOS ANGELES (KABC) – Los Angeles County to stop using a COVID-19 test produced by Curative that has been found to pose a risk of false negative results The United States Food and Drug Administration recently issued an alert on Curative’s COVID-19 test, saying that, particularly if the test is not performed as authorized, “there is a greater risk that the test results will not be accurate.”

The Curative test is used at the Los Angeles sites. The county says about 10% of tests conducted at the county’s contextual testing sites from Dec. 13 to Jan. 2 were curative tests. The county said on Sunday as a precautionary measure it would stop using the curative test on sites supported by the county and will use a test from Fulgent Genetics instead.

In addition to the county’s pop-up test sites, Curative’s website says the company is involved in running at least three dozen test sites in the city of Los Angeles, including Dodger Stadium. It was not immediately clear whether the city of Los Angeles was also considering ending its partnership with the company.

Mayor Eric Garcetti last week defended the curative tests, saying their administration to asymptomatic people had allowed the city to catch the virus from 92,000 people who otherwise would not have been detected.

“The evidence is that we have had a third of the people, almost 100,000 people who would not have been diagnosed, that we were able to catch with this test – and it helped us predict these outbreaks of hospitalizations and death as a result. “I’m never going to apologize because there has been, I think, a lot of debate about whether or not asymptomatic people should be tested. ”

Curative, a San Dimas-based diagnostics company, defended its testing, recently issuing a statement: “Curative’s test has been validated and is being offered during the pandemic under emergency use authorization, and is labeled with warnings, precautions and specific limitations which the FDA reiterated in the safety communication, ”according to a statement from the company.

“Test performance and labeling, however, has not changed, and the company has not observed any change in test performance. We have worked with the agency to address their concerns and these limitations, and we will continue to work interactively with the FDA through the Emergency Use Authorization. ”

Curative has administered more than 11 million tests nationwide, including in other major cities like San Francisco, Chicago, Houston and Atlanta.

County officials also noted that any test could carry some risk of a false positive.

“All COVID-19 tests carry a risk of false negative results, which means you can test negative when you actually have COVID-19,” the county noted.

“Indeed, the sensitivity depends on the quality of the sample taken and the concentration of viral RNA in the sample. There is no reliable way to spot an infection early, which means the infection often spreads before symptoms develop. Nevertheless, PCR tests, including the Curative Test, are still better at detecting disease than other tests, including rapid tests. ”

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