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Home / Business / Los Angeles County stops using efficacy tests after FDA warns of false negatives

Los Angeles County stops using efficacy tests after FDA warns of false negatives



Los Angeles (KABC)-Los Angeles County will stop using the COVID-19 test produced by Curative, which is found to be at risk of false negative results.

The US Food and Drug Administration recently issued an alert regarding Curative’s COVID-19 test, specifically stating that if the test is not performed as authorized, “the risk of incorrect test results is greater.”

Curative’s test is used at sites throughout Los Angeles. The county stated that about 10% of the tests performed at the county’s pop-up test site from December 13 to January 2 were therapeutic tests.

The county said on Sunday that as a precaution, it will stop using “curative” tests at county-supported sites and will use Fulgent Genetics tests instead.

In addition to the county pop-up test site, Curative̵

7;s website also shows that the company is participating in running at least three dozen test sites in Los Angeles, including Dodger Stadium. It is not clear whether the city of Los Angeles also plans to terminate its partnership with the company.

Mayor Eric Garcetti defended the “curative trial” last week, saying that the management of asymptomatic people has infected the city with the virus among 92,000 people who would otherwise be found.

“There is evidence that one-third of us and nearly 100,000 have not been diagnosed because of this test we were able to catch-and it helped us predict the surge in hospitalizations and deaths, Seti said, “I will always I won’t apologize, because I think there is a lot of debate about whether asymptomatic people should be tested. “

Curative, a diagnostic company in San Dimas, defended its test and recently issued a statement: “Curative’s test has been verified and has been authorized for emergency use during the pandemic, with specific warnings. Matters and restrictions, the FDA reiterated this in its safety communications,” according to a statement from the company.

“However, test performance and labeling have not changed, and the company has not observed any changes in test performance. We have been working with the agency to resolve their concerns and these restrictions, and we will continue to interact with the FDA through the following methods for emergency use authorization. ”

Curative has conducted more than 11 million tests nationwide, including other major cities such as San Francisco, Chicago, Houston, and Atlanta.

County officials also pointed out that any test may bring the risk of false positives.

The county stated: “All COVID-19 tests have a risk of false negative results, which means you may test negative when you actually have COVID-19.”

“This is because the sensitivity depends on the degree of sample collection and the concentration of viral RNA in the sample. There is no reliable method to detect early infections, which means that infections usually spread before symptoms develop. However, PCR testing includes radical testing in It is better to detect diseases than other tests, including rapid tests.”

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