The US Food and Drug Administration recently issued a warning about Curative’s COVID-19 test, saying that especially if the test is not performed as authorized, “there is a greater risk that the results of the test may not be accurate.”
Curative’s test is being used at locations around Los Angeles. The county says that about 10% of the tests conducted at the county pop-up test sites from Dec. 13 to Jan. 2 were curative tests.
The county said Sunday as a precautionary measure, it will discontinue use of the curative test in county-supported sites and use a test from Fulgent Genetics instead.
In addition to pop-up test sites across the county, Curative’s website indicates that 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 also intends to end its partnership with the company.
Mayor Eric Garcetti defended the curative tests last week, saying that administering it to asymptomatic people had caused the city to contract the virus in 92,000 people who would otherwise have gone unnoticed.
“The evidence is that we’ve had a third of the people, almost 100,000 people who would be undiagnosed, that we were able to catch thanks to this test – and it helped us predict those spikes in hospital admissions and deaths as a result.” Garcetti. ‘ I’m never going to apologize, because there was, I think, a lot of discussion about whether or not asymptomatic people should be tested. ‘
Curative, a diagnostics company based in San Dimas, has defended its tests by recently issuing a statement: “Curative’s test has been validated and offered under an emergency use authorization during the pandemic, and is labeled with specific warnings, precautions and restrictions that FDA reiterated in safety communications, ” the company said.
However, test performance and labeling have not changed, nor has the company observed any changes in test performance. We have worked with the agency to address their concerns and these limitations, and we will continue to interact with the FDA through the Authorization for emergency use. ”
Curative has conducted more than 11 million tests nationwide, including in other major cities such as San Francisco, Chicago, Houston and Atlanta.
County officials also noted that any test carries some risk of a false positive result.
“All COVID-19 tests have a risk of false negative results, which means you can test negative if you actually have COVID-19,” noted the county.
“That’s 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 early infection, which means infection often spreads before symptoms develop. Nevertheless,” his PCR tests, including the Curative test, remain better at detecting disease than other tests, including rapid tests. ”
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