The Sonoma County Department of Health has terminated a short 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 led to other public institutions stopping its use.
Provincial public health officials said Monday they had stepped away from a community testing pilot program with Curative in Southern California because the profitable venture’s screening strategy did not align well with local outreach efforts in communities here that were hit hard by the virus does not.
“It was an experiment, and the experiment failed because their model is different from the way we work on test sites to provide outreach and education,” said D’Arcy Richardson, director of nursing in the province’s public health department. , said during a media conference.
Provincial officials on Monday said public health personnel would resume their own pop-up COVID-19 test in neighborhoods on Friday. Officials said Curative could continue to conduct tests itself.
Earlier Monday in an interview, provincial health official Dr Sundari Mase reiterated what she said in an information session on Friday that the country had no test contract with Curative. At Monday’s briefing, Mase postponed questions about Curative to Richardson.
On Dec. 22, Sonoma County announced that it has partnered with Curative to launch six “pop-up test sites,” starting Dec. 28 in Sonoma, Santa Rosa, Healdsburg and Rohnert Park to increase the number of virus tests in communities . . The province said in the announcement that it will continue to provide bilingual and bilingual health workers on site, and expects Curative to conduct up to 900 tests per week. As of Friday, however, Curative has tested in five places.
The pivot of the country comes amid growing concerns about the accuracy of the curative test and its limitations. Instead of a health worker collecting samples through the nose, which Richardson called the ‘gold standard’ for COVID-19 screening, the Curative test is self-administered and done orally.
On January 4, the FDA issued an advice that Curative’s virus test has a greater risk of producing a false negative when used on asymptomatic people and not used according to federal emergency authorization guidelines. The agency said the test should be limited to individuals who have symptoms of COVID-19, and within 14 days of the onset of these symptoms. Public health officials in the province on Monday referred a question as to whether Curative had tested local residents without virus symptoms to the company.
Officials in the United Healdsburg School District are now reevaluating plans to use the Curative Test to meet state requirements to eventually reopen campuses for personal classes.
Emails left by a Press Democrat reporter with a Curative spokesman on Monday to ask for an interview to answer questions about the company’s testing were not returned.
The Los Angeles County Department of Public Health said on Sunday it would stop using the year-old company’s test on pop-up screening sites over concerns about accuracy.
Last week, the company told the Los Angeles Times that the test was approved by the FDA under an “emergency use authorization”.
However, the test performance and other information that Curative used to obtain FDA emergency authorization did not include patients who were asymptomatic. The application, which was approved in April, noted that the test was “limited to patients with symptoms of COVID-19”, reports the LA Times.
The FDA warning about the accuracy of the Curative test caught the attention of the Healdsburg school district from 1400 students from kindergarten to 12th grade and 200 employees. The district has contracted with Curative for virus screening services.
The union for teachers in the district has expressed concern about administrators over the FDA, who have pointed out that curative tests should only be given to people with COVID-19 symptoms. Only a week into the contract, the district is now reviewing other test options, Superintendent Chris Vanden Huevel said.
‘The test is self-administered and sent to the laboratory and the results are fairly fast. It sounded like a perfect system, ‘said Vanden Huevel. “It is clear that these issues were raised at the end of last week 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, according to federal guidelines, does help improve the testing capacity of the area.
“None of the tests we do are perfect,” she said. “What we really want to avoid is throwing the baby away with the bathwater, because all these tests use it.”
In neighboring Marin County, public health officials said Friday that Curative continues to offer tests there. The company delivers 1,000 tests a day to the country in the south.
Sonoma County officials said Monday they do not know when asked how many people received the curative tests at neighborhood test sites, how many of the tests came back positive or whether any of the people tested were symptomatic.
“There’s a use for the Curative test,” Richardson said, “definitely for people who are symptomatic.”
You can contact staff writer Martin Espinoza at 707-521-5213 or [email protected]. On Twitter @pressreno. You can contact staff writer Kevin Fixler at 707-521-5336 or [email protected]. On Twitter @kfixler