The US Food and Drug Administration recently issued an alert on Curative’s COVID-19 test, saying that especially if the test is not performed as authorized, “there is a higher risk that the test results will not be accurate.”
The healing test is used on sites in Los Angeles. The county says that approximately 10% of the tests performed at the county locations between December 13 and January 2 were curative tests.
The county said on Sunday as a precautionary measure that it will stop using the curative test at sites supported by the county and will instead use a Fulgent Genetics test.
In addition to the county’s pop-up test sites, Curative’s website indicates that the company is involved in managing at least three dozen test sites in Los Angeles, including Dodger Stadium. It was not immediately clear whether the city of Los Angeles also intends to end the partnership with the company.
Mayor Eric Garcetti defended the curative tests last week, saying that their administration to asymptomatic people allowed the city to catch the virus in 92,000 people who would otherwise have been undetected.
“The proof is that we had a third of the people, almost 100,000 people who would have gone undiagnosed, that we managed to catch because of this test – and it helped us predict these increases in hospitalizations and deaths as a result.” I’m never going to apologize because there was, I think, a lot of debate about whether or not asymptomatic people should be tested. “
Curative, a diagnostic company based in San Dimas, defended its tests, recently publishing a statement: “The curative test has been validated and is offered during the pandemic on the basis of an emergency use permit and is labeled with specific warnings, precautions and limitations that the FDA has reiterated in the safety communication, “according to a company statement.
“However, the performance and labeling of the test did not change and the company did not notice any changes in the performance of the test. We have worked with the agency to address these concerns and limitations and 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 such as San Francisco, Chicago, Houston and Atlanta.
County officials also mentioned that any test may present a certain risk of false positive.
“All COVID-19 tests present a risk of false negative results, which means that you can have negative results when you actually have COVID-19,” the county said.
“This is because the sensitivity depends on how well the sample was collected and the concentration of viral RNA in the sample. There is no reliable way to detect the infection early, which means that the infection often spreads before symptoms develop. however, PCR tests, including the curative test, remain better at detecting the disease than other tests, including rapid tests. ”
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