The U.S. Food and Drug Administration recently issued an alert on Curative’s COVID-19 test, saying that particularly if the test is not performed in an authorized manner, “there is a greater risk that the test results will not be accurate “.
The healing test is used in places all over Los Angeles. The county says approximately 10% of the tests conducted at the county’s emerging testing sites from Dec. 13 to Jan. 2 were curative tests.
The county said Sunday as a precaution it will stop using the curative test in places with county support and will instead use a Fulgent Genetics test.
In addition to the county’s emerging testing sites, the Curative website indicates that the company is involved in managing at least three dozen test sites in the city of Los Angeles, including Dodger Stadium. It was not immediately clear if the city of Los Angeles also plans to terminate its partnership with the company.
Mayor Eric Garcetti last week defended the curative tests, saying administering them to asymptomatic people has allowed the city to catch the virus in 92,000 people who would otherwise have gone undetected.
“The proof is that we had a third of the people, about 100,000 people who would have been undiagnosed, that we were able to capture because of this test, and it has helped us predict those hospitalizations and deaths as a result. “I’m not going to apologize because I think there was a lot of debate about whether asymptomatic people should be tested or not,” Garcetti said.
Curative, a San Dimas-based diagnostic company, has defended its tests and recently issued a statement: “The curative test has been validated and offered during the pandemic under an emergency use permit and is labeled with specific warnings, precautions and limitations that the FDA reiterated in the safety communication, “according to a company statement.
“Test performance and labeling, however, have not changed nor has the company noticed any change in test performance. We have been working with the agency to address its concerns and limitations and will continue to work interactive with the FDA through Emergency Use Authorization “.
Curative has administered more than 11 million trials nationwide, including in other major cities such as San Francisco, Chicago, Houston and Atlanta.
County officials also noted that any test may carry some risk of false positive.
“All COVID-19 tests have a risk of false negative results, which means you can test negative when you actually have COVID-19,” the county noted.
“This is because sensitivity depends on the degree of sample collection and the concentration of viral RNA in the sample. There is no reliable way to detect infection early, which means the infection often spreads earlier. However, PCR tests, including the curative test, are still better at detecting disease than other tests, including rapid tests. ”
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