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Sonoma County is stepping down from curative virus testing that attracted FDA concerns



Sonoma County’s health department has concluded a brief partnership with a coronavirus test company that last week issued a U.S. Food and Drug Administration warning of the risk of false negative results that have prompted other government entities to stop using the test.

Public health officials said Monday they walked away from a test community testing program with the Southern California-based Curative because the profitable company’s screening strategy does not fit well with the local outreach efforts in communities here that are hard hit by the virus.

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

; D’Arcy Richardson, director of nursing in the county’s Department of Public Health, said during a media briefing.

County officials said Monday that public health personnel will resume its own pop-up test COVID-19 in neighborhoods on Friday. Officials said Curative can continue to perform tests alone.

Earlier Monday in an interview, the county health officer Dr. Sundari Mase, what she had said Friday in a briefing that the county had no test contract with Curative. At Monday’s briefing, Mase put questions of curative to Richardson.

On December 22, Sonoma County announced that it is “collaborating” with Curative to handle six “pop-up test sites” beginning December 28 in Sonoma, Santa Rosa, Healdsburg and Rohnert Park to increase the number of virus tests in community . The county said in the announcement that it would continue to provide bilingual and bilingual health staff on the premises and expected Curative to perform up to 900 tests per week. As of Friday, however, Curative tested in five locations.

The county’s focal point comes amid growing concerns about the accuracy of the curative test and its limitations. Instead of a health professional collecting samples through the nose, which Richardson called the “gold standard” for COVID-19 screening, Curative’s test is self-administered and performed orally.

On January 4, the FDA issued an advice that Curatives virus test has a greater risk of producing a false negative when applied to asymptomatic people and not used in accordance with federal emergency permit guidelines. The agency said the test should be limited to individuals who have shown symptoms of COVID-19 and within 14 days of the onset of symptoms. County Public Health officials referred a question Monday about whether Curative tested local residents without virus symptoms for the company.

Healdsburg Unified School District officials are now reconsidering plans to use the curative test to meet state requirements to eventually reopen campuses for personal classes.

Email messages a press Democrat reporter left with a curative spokeswoman Monday and sought an interview to answer questions about the company’s test were not returned.

On Sunday, the Los Angeles County Public Health Department said it would stop using the year-old company’s test at pop-up screening sites due to accuracy issues.

Last week, the company told the Los Angeles Times that its test has been validated by the FDA during a “emergency use” pandemic.

However, the performance of the test and other information, Curative, used to seek FDA emergency clearance did not include patients who were asymptomatic. The company’s application, which was approved in April, noted that the test is “limited to patients with symptoms of COVID-19,” the LA Times reported.

The FDA warning about Curatives’ test accuracy received attention from the Healdsburg school district of 1,400 students from preschoolers to 12th graders and 200 employees. The district has contracted with Curative for virus screening services.

The district teachers’ association logged concerns about administrators across the FDA, who warned that curative tests should only be given to people with COVID-19 symptoms. Just a week into the contract, the district is now reviewing other testing options, said Superintendent Chris Vanden Huevel.

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

Meanwhile, Richardson, an infectious disease expert, pointed out that the Curative virus test, when used according to federal guidelines, helps strengthen the testing capacity of the area.

“None of the tests we have are perfect,” she said. “What we really want to avoid is throwing the baby out with the bath water because there are uses for all these tests.”

In nearby Marin County, public health officials said Friday that Curative will continue to offer tests there. The company has delivered county to the south 1,000 tests a day.

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

“The curative test is needed,” Richardson said, “specifically for people who are symptomatic.”

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


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