The Sonoma County Health Department has closed a brief partnership with a coronavirus testing company that last week generated a warning from the U.S. Food and Drug Administration about the risks of false negative results that have prompted other public authorities to stop using the test.
County public health officials said on Monday that they had abandoned a pilot community testing program with Curative, based in Southern California, because the company’s for-profit screening strategy did not match 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 from the way we operate on test sites in terms of outreach and education,” D’Arcy Richardson, director of nursing for the county’s public health division, said during a press conference.
County officials said on Monday that the public health team would resume its own COVID-19 pop-up tests in the neighborhoods on Friday. The authorities said Curative may continue to conduct tests on its own.
On Monday, in an interview, the county health officer, Dr. Sundari Mase, repeated what she said on Friday at a briefing that the county had no test contract with Curative. At Monday’s briefing, Mase postponed questions about Curative to Richardson.
On December 22, Sonoma County announced that it is “partnering” with Curative to address six “pop-up test sites”, starting on December 28 in Sonoma, Santa Rosa, Healdsburg and Rohnert Park to increase the number of virus tests in communities. The county said in the announcement that it would continue to provide bilingual and bicultural health professionals at the sites, and expects Curative to run up to 900 exams a week. On Friday, however, Curative was testing at five locations.
The county pivot comes amid growing concerns about the accuracy of the Curative test and its limitations. Instead of a health professional collecting samples through the nose, what Richardson called the “gold standard” for the COVID-19 screening, the Curative test is self-administered and performed orally.
On January 4, the FDA issued a statement that Curative’s virus test has an increased 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 had symptoms of COVID-19, and up to 14 days after the onset of symptoms. County public health officials asked the company a question on Monday whether Curative was testing local residents without virus symptoms.
Healdsburg unified school district officials are now reevaluating plans to use the curative test to meet state requirements to eventually reopen campuses for face-to-face classes.
The e-mail messages that a Press Democrat reporter left with a Curative spokeswoman on Monday, seeking an interview to answer questions about the company’s tests, were not returned.
On Sunday, the Los Angeles County Department of Public Health said it would stop using the company’s test, which has been running for a year, on pop-up screening sites due to accuracy concerns.
Last week, the company told the Los Angeles Times that its test was validated by the FDA under a “emergency use authorization” pandemic.
However, test performance and other curative information used to apply for FDA emergency clearance did not include asymptomatic patients. The company’s application, which was approved in April, noted that the test is “limited to patients with symptoms of COVID-19,” reported the LA Times.
The FDA’s warning about the accuracy of the Curative test caught the attention of the Healdsburg school district from 1,400 pre-kindergarten students to 12th grade and 200 employees. The district hired Curative for virus screening services.
The district teachers’ union has registered concerns with administrators about the FDA warning that curative tests should be administered only to people with symptoms of COVID-19. Just a week after the start of the contract, the district is now looking at other testing options, said Superintendent Chris Vanden Huevel.
“The test is self-administered and sent to the laboratory and the results are very fast. It looked like a perfect system, ”said Vanden Huevel. “Obviously, at the end of last week, these issues were raised and we are now in a place where we need to reconsider.”
Meanwhile, Richardson, an infectious disease specialist, pointed out that curative virus testing, when used according to federal guidelines, helps increase the area’s testing capacity.
“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 all of these tests can be used.”
In neighboring Marin County, public health officials said on Friday that Curative will continue to offer tests there. The company has provided the southern county with 1,000 tests a day.
Sonoma County officials said on Monday that they did not know, when asked how many people had received curative tests at neighborhood test sites, how many of the tests were positive or whether any of the people tested were asymptomatic.
“The curative test is useful,” said Richardson, “certainly for symptomatic people.”
You can contact editor Martin Espinoza at 707-521-5213 or [email protected]. On Twitter @pressreno. You can contact editor Kevin Fixler at 707-521-5336 or [email protected]. On Twitter @kfixler