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Sonoma County steps back from Curative virus testing that drew FDA concerns

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Sonoma County’s health department has ended a brief partnership with a coronavirus testing company that last week drew a U.S. Food and Drug Administration warning over the risks of false negative results that have led other public entities to stop using the test.

County public health officials said Monday they walked away from a pilot community testing program with Southern California-based Curative, because the for-profit company’s screening strategy did not mesh well with local outreach efforts in communities here that have been hit hard by the virus.

“It was an experiment, and the experiment failed because their model is different than the way that we operate at testing sites in terms of trying to provide outreach and education,” D’Arcy Richardson, director of nursing in the county’s public health division, said during a media briefing.

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

Earlier Monday in an interview, county Health Officer Dr. Sundari Mase repeated what she had said Friday in a briefing that the county had no testing contract with Curative. At Monday’s briefing, Mase deferred questions about Curative to Richardson.

On Dec. 22, Sonoma County announced it is “partnering” with Curative to handle six “pop-up testing sites,” beginning Dec. 28, in Sonoma, Santa Rosa, Healdsburg and Rohnert Park to boost the number of virus tests in communities. The county said in the announcement that it would continue to provide bilingual and bicultural health care workers at the sites, and expected Curative to do up to 900 tests a week. As of Friday, however, Curative was testing at five sites.

The county’s pivot comes amid growing concerns over the accuracy of the Curative test and its limitations. Rather than a health professional collecting specimens through the nose, which Richardson called the “gold standard” for COVID-19 screening, Curative’s test is self-administered and done orally.

On Jan. 4, the FDA issued an advisory that Curative’s virus test has a greater risk of producing a false negative when used on asymptomatic people and not used in accordance with federal emergency authorization guidelines. The agency said the test should be limited to individuals who have shown symptoms of COVID-19, and within 14 days of onset of those symptoms. County public health officials referred a question Monday whether Curative was testing local residents with no virus symptoms to the company.

Officials at Healdsburg Unified School District now are reevaluating plans to use the Curative test to meet state requirements toward eventually reopening campuses for in-person classes.

Email messages a Press Democrat reporter left with a Curative spokeswoman Monday seeking an interview to answer questions about the company’s testing 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 over accuracy concerns.

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

However, the test performance and other information Curative used to seek FDA emergency authorization 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 Curative’s test accuracy got the attention of the Healdsburg school district of 1,400 students from pre-kindergarten to 12th grade and 200 employees. The district has contracted with Curative for virus screening services.

The district’s teachers’ union logged concerns with administrators over the FDA alerting that Curative tests should be given only to people with COVID-19 symptoms. Just a week into the contract, the district is now reviewing other testing options, Superintendent Chris Vanden Huevel said.

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

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

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

In neighboring Marin County, public health officials said Friday that Curative will continue to offer tests there. The company has been providing the county to the south 1,000 tests per day.

Sonoma County officials Monday said they didn’t know when asked how many people had received the Curative tests at neighborhood testing sites, how many of the tests came back positive, or if any of the people tested were asymptomatic.

“There is a use for the Curative test,” Richardson said, “certainly 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

Track coronavirus cases in Sonoma County, across California, the United States and around the world here.

For more stories about the coronavirus, go here.

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