The U.S. 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 test results will not be accurate. can not be. ‘
Curative’s test is used in locations in Los Angeles. According to the province, about 10% of the tests carried out on provincial sites from 13 December to 2 January were curing tests.
The province said Sunday as a precaution that the Curative test would no longer be supported on the provinces and would rather use a test by Fulgent Genetics.
In addition to the provincial 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 immediately clear whether the city of Los Angeles also intends to terminate its partnership with the company.
Mayor Eric Garcetti defended the Curative tests last week, saying its administration to asymptomatic people allowed the city to detect the virus in 92,000 people who would otherwise be unnoticed.
“The proof is that we had a third of the people, almost 100,000 people who would not be diagnosed, that we could catch because of this test – and that helped us to stop the increases in hospitalizations and deaths as a result “I never intended to apologize, because I think there were a lot of debates about whether people should be tested without symptoms or not.”
Curative, a diagnostic firm in San Dimas, defended its tests and recently issued a statement: ‘Curative’s test was validated and presented during the pandemic under emergency permits, and was marked with specific warnings, precautions and restrictions imposed by FDA repeated in the safety communication, ” according to a statement from the company.
“However, the test performance and labeling have not changed, nor has the company observed any changes in the test performance. We are working with the agency to address their concerns and these limitations, and we will continue to interact with the FDA. to work 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.
Officials in the province also noted that any test could have a risk of a false positive.
“All COVID-19 tests have a risk of false negative results, which means you may test negative if you have COVID-19,” the country 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 early infection, which means that infection often spreads before symptoms develop. Nevertheless, PCR- Tests, including the The curative test remains better at detecting diseases than other tests, including rapid tests. ”
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