Citing a lack of quality documentation, San Diego County’s public health authorities ordered a pop-up clinic operating out of a local community college parking lot to immediately stop offering novel coronavirus blood tests Wednesday, April 15, less than three days after it opened.
Called COVID Clinic, the Orange County business was the first in the region to begin offering rapid testing for the presence of blood antibodies that can indicate a person was infected by the pathogen currently causing a global pandemic.
Dr. Eric McDonald, director of the county’s epidemiology department, said during a daily COVID briefing Wednesday afternoon, April 15, that a shut-down order was issued after the clinic, run by a doctor group out of Huntington Beach, failed to provide a certification that its lab was properly certified and also additional validation data to prove that its blood test actually works as designed.
“We have yet to get that information, so we issued an order telling them to no longer do that test,” McDonald said.
The statement came just after public health officials announced that the county has now reached 2,000 confirmed COVID cases and seven additional deaths, ranging in age from the mid-60s to a 100-year-old woman.
Congregate living facilities, including skilled nursing homes and assisted living centers, continue to be hit hard with 20 outbreaks now confirmed in such locations, accounting for 22 deaths so far.
The county also provided more clarity on enforcement of stay-at-home orders Wednesday, April 15, as San Diego Zoo Global notified the public of worker furloughs.
But the biggest news to land Wednesday, April 15, on the COVID front had to do with the line of cars waiting in line at MiraCosta College’s San Elijo campus in Cardiff, their drivers pulling under an awning one-by-one to provide samples for testing. The clinic collects both finger-stick blood samples and nasal swabs depending on whether its customers want a blood test or a DNA test. The genetic variant, McDonald said, is not affected by the public health shutdown order because testing is performed at a certified lab in Texas.
Testing shut down
Matt Collins, who said Tuesday, April 14, that he is the company’s media representative, was not available Wednesday afternoon, April 15, to verify that COVID Clinic has stopped performing blood antibody testing as ordered or to explain why the operation is still up and running at MiraCosta. The voicemail for his phone number, provided to the Union-Tribune by a company official Tuesday, April 14, was not set up.
Asked what he made of the fact that the operation was still underway, McDonald had a simple answer.
“If I was in line waiting for a test, I would get out of line,” McDonald said.
San Diego County Sheriff Bill Gore said Wednesday afternoon, April 15, that MiraCosta had been ordered to stop allowing the company to operate on its property.
“If they disobeyed that, then I can guarantee you enforcement action will be taken,” Gore said.
In a statement, MiraCosta said it was notified of the order Wednesday afternoon, April 15, and told the clinic that “they must cease testing as soon as possible; no later than the end of business today.” The college said it granted the clinic a five-day period to use its parking lot, waiving all rental fees “to support the community good during a pandemic.”
Reached Tuesday afternoon, April 14, Collins confirmed that the company has been using a blood antigen test provided by San Diego-based Confirm Biosciences. As has been the case for many such offerings recently, Confirm’s test is not approved by the U.S. Food and Drug Administration and was created under special guidance that the regulator published on March 16.
That guidance provided a path for individual companies to develop and release such tests without going through the FDA’s formal Emergency Use Authorization process provided they fully validate their work by comparing results to those obtained through polymerase chain reaction testing. DNA-based tests have so far been the main way that COVID-19 cases are confirmed.
Confirm Biosciences, which has been in business in San Diego for a decade, has posted some results from its new coronavirus antibody test on its website which indicate its effectiveness was evaluated in February at 10 different hospitals, though no information is available on which hospitals were involved or where they are located. A table of results included in the brief post indicates that the positive results agreed with references 93.7 percent of the time and with negative results 99.1 percent of the time.
But experts were not convinced. Dr. Robert “Chip” Schooley, a UC San Diego infectious disease specialist and editor of the medical journal Clinical Infectious Diseases, took a look at the available data Tuesday evening, April 14, and found it lacking.
“The data do not specify the reference test to which it was compared,” Schooley noted in an email. “It is worrisome that 16 of 261 (people) that were tested as positive on the reference test were missed by the Confirm Biosciences test and that four of the 443 negative reference tests were called positive by the Confirm Biosciences test.”
On its website, the company states that “more detailed results of ongoing clinical evaluations and test stability” are “available upon request.”
However, after the Union-Tribune requested that additional information Tuesday, April 14, a company spokesman said Wednesday, April 15, that no additional data would be forthcoming.
In an emailed statement, the company said: “At this time, Confirm can only share the information with medical groups vetted through an authorization process as part of the emergency use guidelines. They cannot share outside of these groups for the time being.
Essential apple pie?
Gore took an opportunity Wednesday, April 15, to address recent reports that his deputies have stopped motorists to verify that they’re not violating the current ban on nonessential trips.
“We are not stopping cars and asking people their destination,” Gore said. “It’s just not happening. I’ve had reports of that. I think some people might have gotten stopped for a traffic violation and they thought they were being stopped to check if they were in compliance with the county health order. That’s not the instructions to our deputies and they shouldn’t be doing that.”
Gore said there has been an ongoing issue with people traveling to the mountain community of Julian, with many going just to get apple pies.
“Driving to Julian to get pie -- as good as it is and I love Julian pie -- is not really essential,” he said, adding that too many such trips crowd the small mountain community.
Deputies have been trying to educate people, but also had issued citations, he said.
Cara Teter, owner of the Julian Cafe for 33 years, said deputies routinely appear in front of her business to ask people in line to disperse, although they are practicing social distancing and she is following all county orders.
“I understand the Sheriff is just doing what their job is, but I think they’ve taken it a little out of control,” she said. “We’ve had some outlandish statements from the sheriffs, like ‘Do you want to die in Julian? You’re supposed to be quarantined. What are you doing here? How do you know there’s not COVID-19 on that to-go box?’”
Attorney Michael Justice of West Lake Village, who said he learned of the situation from his son, who visited Julian over the weekend for pie, is demanding a slice of justice, threatening a civil lawsuit if the sheriff doesn’t make his employee cease and desist.
Teter said the situation is one of survival for her business. Sales that once were about $2,000 a day have dropped to about $100, she said, and her insurance company has denied her any compensation for damages.
Also at the Wednesday, April 15, press briefing, former San Diego Charger Rolf Benirschke, CEO of Legacy Health Strategies, promoted a campaign #StayOnTheBenchSD that features famed San Diego athletes encouraging people to stay home to help curb the spread of the virus.
“We don’t know if this is the first quarter, it’s halftime, or we’re getting to enter the fourth quarter,” he said. “But we need to maintain what the officials are telling us.”
A video clip of the campaign included Trevor Hoffman, Wally Joiner, Buddy Black, Ed White and Phil Nevin.
The financial pain continued to spread as San Diego Zoo Global, the umbrella organization for the zoo in Balboa Park and the Safari Park in Escondido, announced furloughs Wednesday, April 15. Both facilities are closed to visitors because of the pandemic.
Officials said in a statement that workers who perform visitor-related duties that “have been significantly impacted” by the shut-downs will stop working next week. Health benefits will continue for those currently receiving them.
Also on Wednesday, April 15, members of the San Diego Congressional Delegation sent a letter to House leadership requesting that federal financial assistance for the San Diego Zoo and San Diego Zoo Safari Park be included in an upcoming relief bill.
Specifically, the letter, addressed to House Speaker Nancy Pelosi and House Minority Leader Kevin McCarthy, asks that at least $1 billion be allocated to the Institute of Museum and Library Services in the upcoming bill in an effort to support zoos, aquariums, and museums as they deal with the impacts of COVID-19.
In making an appeal to leadership, the delegation — which includes Reps. Susan Davis, Juan Vargas, Scott Peters and Mike Levin, all Democrats — highlighted the tremendous economic impact the San Diego Zoo and San Diego Safari Park have on the region.
The members said the zoo generates an estimated $1.7 billion economic impact annually, employs more than 3,000 Californians, and indirectly contributes to more than 14,000 other jobs in San Diego.
“Unfortunately, this economic activity has been severely impacted by the COVID-19 pandemic, which now threatens the zoo’s operations, the animals they care for, and the jobs of many of our constituents,” the letter states.
“To sustain base operations during this challenging time, SDZG requires the aid of our federal government until they can once again serve as the economic engine of our community.”
— Paul Sisson and Gary Warth are reporters for The San Diego Union-Tribune
— Staff writers Charles Clark and John Wilkens contributed to this report.