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

LOS ANGELES (KABC) – Los Angeles County will stop using the COVID-19 test, manufactured by Curative, which has been found to be at risk of false negative results.

The US Food and Drug Administration recently issued a signal for Curative’s COVID-19 test, which states that especially if the test is not performed in an authorized manner, “there is a greater risk that the test results will not be accurate.”

The Curative test is used on sites in Los Angeles. The county says about 10 percent of the tests performed on county test sites from Dec. 13 to Jan. 2 are curative tests.

The county said Sunday as a precaution that it would stop using the treatment test on county-backed sites and use a Fulgent Genetics test instead.

In addition to the pop-up graph sites, Curative̵

7;s website shows that the company is involved in the management of at least three dozen test sites in the city of Los Angeles, including Dodger Stadium. It was unclear whether the city of Los Angeles also planned to end its partnership with the company.

Mayor Eric Garsetti defended treatment tests last week, saying applying them to asymptomatic people allowed the city to catch the virus in 92,000 people who would otherwise go unnoticed.

“The proof is that we had a third of the people, nearly 100,000 people, who would go undiagnosed that we were able to catch because of this test – and that helped us predict those hospitalizations and deaths as a result,” Garsetti said. ” I will never apologize, because I think there has been a lot of controversy about whether asymptomatic people should be tested or not. “

Curative, a San Dimas-based diagnostic firm, defended its tests by recently issuing a statement: “The Curative test is validated and offered during the pandemic under an emergency authorization and is marked with specific warnings, precautions and restrictions. which the FDA repeated in safety communications, ”the company said in a statement.

“However, the effectiveness of the test and labeling has not changed, nor has the company noticed any changes in the effectiveness of the test. We are working with the agency to address their concerns and these limitations and will continue to work interactively with the FDA through Emergency 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 note that each test may carry a risk of a false positive result.

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

“This is because the sensitivity depends on how well the sample is collected and the concentration of viral RNA in the sample. There is no reliable way to detect early infection, which means that the infection often spreads before symptoms develop. PCR tests, including the Cure Test, remain better at detecting disease than other tests, including rapid tests. ”

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