The Food and Drug Administration recently issued a warning about Curative’s COVID-19 test, saying that, particularly if the test is not performed as authorized, “there is an increased risk that the test results may not be accurate”.
The Curative test is used on Los Angeles websites. The county says about 10% of the tests carried out at the county’s pop-up test sites from December 13 to January 2 were curative tests.
The county said on Sunday as a precaution that it will stop using the Curative test on county-backed sites 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 the management of at least three dozen test sites in the city of Los Angeles, including Dodger Stadium. It was not clear whether the city of Los Angeles also plans to discontinue its partnership with the company.
Mayor Eric Garcetti defended the curative tests last week, saying that administering them to asymptomatic people allowed the city to catch the virus in 92,000 people who would otherwise not have been detected.
“The proof is that we had a third of the people, almost 100,000 people who would not have been diagnosed, that we were able to catch because of this test – and it helped us predict the spikes in hospitalizations and deaths as a result,” said Garcetti. I’m going to apologize because there was, I think, a lot of debate about whether asymptomatic people should be tested or not. “
Curative, a diagnostic company based in San Dimas, defended its tests by issuing a statement recently: “The Curative test has been validated and is being offered during the pandemic under an Emergency Use Authorization, and is labeled with warnings, precautions and specific limitations that the FDA reiterated in safety communication, ” according to a company statement.
“Test performance and labeling, however, have not changed, nor has the company observed any changes in test performance. We have worked with the agency to address its concerns and these limitations and will continue to work interactively with the FDA through the Authorization emergency use. ”
Curative has administered more than 11 million tests across the country, including in other major cities like San Francisco, Chicago, Houston and Atlanta.
County officials also noted that any test may present a risk of a false positive.
“All COVID-19 tests are at risk of false negative results, which means that you can test negatives when you actually have COVID-19,” noted the county.
“This is because 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 usually spreads before symptoms develop. However, PCR tests, including the curative test, remain better at detecting disease than other tests, including rapid tests. ”
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