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Home / Business / Sonoma County withdraws from testing for therapeutic virus that has caused FDA concern

Sonoma County withdraws from testing for therapeutic virus that has caused FDA concern



The Sonoma County Health Department has ended its brief cooperation with the coronavirus testing company, which issued a warning to the U.S. Food and Drug Administration (FDA) last week that its false negative results may cause other public entities to stop using the test. .

County public health officials said on Monday that they abandoned the community testing pilot program with Curative in Southern California because the for-profit company’s screening strategy did not match the local publicity efforts in the area that had been severely hit by the virus.

“This is an experiment, but the experiment failed because their models are different from the way we operate at the test site to provide publicity and education,”

; said D’Arcy Richardson, the nursing director of the county’s public health department, in the media. Said at the meeting.

County officials said public health personnel on Monday will resume their pop-up COVID-19 tests in the community on Friday. Officials said that Curative can continue to conduct tests on its own.

In an interview earlier on Monday, the county health officer, Dr. Sundari Mase, repeated what she said in a Friday briefing that the county did not sign a testing contract with Curative. In Monday’s briefing, Maas deferred questions about “Cure” to Richardson.

On December 22nd, Sonoma County announced a “cooperation” with Curative to handle 6 “pop-up test sites”, starting on December 28th in Sonoma, Santa Rosa, Healdsburg, and Luo Nut Park increases the number of virus tests in the community. The county stated in the announcement that it will continue to provide bilingual and bilingual healthcare workers on site and expects Curative to conduct as many as 900 tests per week. However, as of Friday, Curative is testing at five sites.

More and more people are concerned about the accuracy and limitations of the palliative examination, which is the focus of the county. Richardson claimed that he did not collect specimens through his nose, but that Richardson called it the “gold standard” for COVID-19 screening, and he managed it himself orally.

On January 4, the U.S. Food and Drug Administration (FDA) issued an advisory report stating that the use of Curative’s virus test on asymptomatic people is more likely to produce false negatives and is not used in accordance with federal emergency authorization guidelines. The agency stated that the test should be limited to people who have shown symptoms of COVID-19 and should be performed within 14 days of the onset of these symptoms. County public health officials asked the company on Monday whether the company is testing local residents who have no symptoms of the virus.

Healdsburg Unified School District officials are now reassessing plans to use the “physical” test to meet state requirements to eventually reopen the campus for face-to-face classroom learning.

On Monday, a News Democrat reporter and a spokesperson for the person in charge left an email. They sought an interview to answer questions about the company’s test, but none of them returned.

On Sunday, the Los Angeles County Department of Public Health said it would stop using the one-year-old company’s tests on pop-up screening sites for accuracy reasons.

Last week, the company told the Los Angeles Times that its test had passed the FDA’s pandemic “emergency use authorization” verification.

However, the test performance and other information (prescription) used to seek emergency FDA authorization does not include asymptomatic patients. According to the Los Angeles Times, the company’s application was approved in April. The application stated that the test is “limited to patients with COVID-19 symptoms.”

The FDA’s warning about the accuracy of the Curative test caught the attention of the Healdsburg school district, which has 1,400 pre-kindergarten through 12th grade students and 200 employees. The region has signed a virus screening service contract with Curative.

The teachers’ union in the region expressed concern about FDA managers and warned that only people with symptoms of COVID-19 will be tested for therapeutic purposes. Chris Vanden Huevel, the contract director, said that the contract was signed only a week ago and the area is reviewing other testing options.

“The tests are self-managed and sent to the laboratory, and the results are fast. It sounds like a perfect system,” Van Den Heuvel said. “Obviously these issues were raised last weekend, and we are now in a place that needs to be reconsidered.”

At the same time, infectious disease expert Richardson (Richardson) pointed out that the use of curative virus testing in accordance with federal guidelines does help strengthen regional testing capabilities.

She said: “The tests we performed are not perfect.” “What we really want to avoid is throwing the baby out with bath water, because all these tests are useful.”

On Friday, in neighboring Marin County, public health officials said that treatment drugs will continue to be tested in the county. The company provides 1,000 tests daily to the southern part of the county.

Sonoma County officials said on Monday that they did not know when they were asked how many people had received a “curative” test at a neighborhood testing site, how many test results were positive, or whether the testees were asymptomatic.

Richardson said: “Therapeutic testing is useful, and it must be for people with symptoms.”

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


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