Home https://server7.kproxy.com/servlet/redirect.srv/sruj/smyrwpoii/p2/ Business https://server7.kproxy.com/servlet/redirect.srv/sruj/smyrwpoii/p2/ Sonoma County is backing from medical virus tests that have raised FDA concerns

Sonoma County is backing from medical virus tests that have raised FDA concerns



Sonoma County Health Department terminated a brief partnership with a coronavirus testing company that last week warned the U.S. Food and Drug Administration about the risks of false-negative results that prompted other public organizations to stop using the test.

Public health officials said Monday that they dropped the pilot program to test the community with Southern California-based Curative because the company’s non-profit screening strategy did not go well with local community contact efforts. here who are severely affected by the virus.

“It was an experiment, and the experiment failed because their model is different from the way we work on test sites in terms of trying to provide scope and education,”

; said D’Arcy Richardson, director of nursing in the public health department. county, said during a media briefing.

County officials said public health officials on Monday will resume their own pop-up tests for COVID-19 in neighborhoods on Friday. Officials said Curative could continue to conduct tests on its own.

Earlier Monday, in an interview, district health officer Dr. Sundari Masse reiterated what she said at a briefing on Friday that the district does not have a testing contract with Curative. At Monday’s briefing, Mace postponed questions about Richardson’s Curative.

On December 22, Sonoma County announced that it was “partnering” with Curative to tackle six “pop-up testing sites,” starting Dec. 28 in Sonoma, Santa Rosa, Hildsburg and Ronert Park to increase the number of tests for viruses in communities. In the announcement, the county said it would continue to provide bilingual and bicultural health workers at the sites and expects Curative to do up to 900 tests a week. As of Friday, however, Curative is testing at five sites.

The county pivot comes amid growing concerns about the accuracy of the medical test and its limitations. Instead of a health professional collecting samples through the nose, which Richardson calls the “gold standard” for COVID-19 screening, the Curative test is given on its own and taken orally.

On January 4, the FDA issued a warning that the Curative virus test has a higher risk of receiving a false-negative result when used in asymptomatic people and not used in accordance with federal emergency guidelines. The agency said the test should be limited to individuals who showed symptoms of COVID-19 and within 14 days of the onset of those symptoms. Public health officials on Monday asked if Curative was testing locals without the company’s viral symptoms.

Officials in the University of Healdsburg are now re-evaluating their plans to use the medical test to meet state requirements for a possible reopening of personal class campuses.

No emails were returned to a Press Democrat reporter with a Curative spokesman on Monday seeking an interview to answer questions about the company’s testing.

On Sunday, the Los Angeles County Department of Public Health said it would stop using the company’s annual test on pop-up sites for screening due to concerns about accuracy.

Last week, the company told the Los Angeles Times that its test was validated by the FDA under the “emergency authorization” pandemic.

The performance of the test and other information that Curative uses to seek emergency approval for the FDA does not include patients who have been asymptomatic. The company’s statement, approved in April, said the test was “limited to patients with symptoms of COVID-19,” the LA Times reported.

The FDA’s warning about the accuracy of the Curative test caught the attention of the Healdsburg school district of 1,400 preschoolers up to 12th grade and 200 employees. The district has contracted with Curative for virus screening services.

The teachers’ union reported concerns to administrators about the FDA, warning that treatment tests should only be given to people with symptoms of COVID-19. Just a week after the contract was signed, the district is reviewing other testing options, said Chief Chris Vanden Huvel.

“The test is performed independently and sent to the laboratory and the results are quite fast. It sounded like a perfect system, “said Vanden Huvel. “Obviously, these issues were raised at the end of last week, and we are now in a place where we need to reconsider.”

Richardson, an expert on infectious diseases, meanwhile, said the curative virus test, when used under federal guidelines, helps strengthen zone testing capacity.

“None of the tests we have are perfect,” she said. “What we really want to avoid is throwing the baby away with the bathing water, as it has all the applications for all these tests.”

In neighboring Marin County, public health officials said Friday that Curative will continue to offer tests there. The company provides the county in the south with 1,000 tests a day.

On Monday, Sonoma County officials said they did not know when asked how many people had received medical tests at neighborhood test sites, how many had returned positive, or whether any of the people tested were asymptomatic.

“The healing test is used,” Richardson said, “certainly for people who are symptomatic.”

You can contact Staff Writer Martin Espinoza at 707-521-5213 or martin.espinoza@pressdemocrat.com. On Twitter @pressreno. You can contact Staff Writer Kevin Fixler at 707-521-5336 or kevin.fixler@pressdemocrat.com. On Twitter @kfixler


Source link