In late March, residents of the Colorado city of Telluride and surrounding San Miguel County stood in line, alongside marked spots spaced 6 toes aside, to have their blood drawn by medical technicians sporting Tyvek fits, face shields and gloves for a brand new COVID-19 check.
While the Centers for Disease Control and Prevention’s exams for the virus that causes the respiratory sickness have been in brief provide because the outbreak started, this was a brand new kind of check. It wasn’t to see who was sick proper now. It was an antibody check that may assess who had been uncovered and the way widespread the virus was in the neighborhood to tell choices about managing the outbreak.
When part-time Telluride residents and United Biomedical Inc. co-CEOs Mei Mei Hu and Lou Reese had provided to supply their firm’s newly developed COVID-19 antibody exams without cost to not simply Telluride, however all of San Miguel County too, greater than 6,000 of the county’s estimated eight,000 residents jumped on the probability.
“People really want to be part of it,” mentioned Donna Fernald, a house well being nurse who was examined the primary day.
The widespread testing was an experiment on this neighborhood greatest recognized for its tony ski resort and summer time music festivals. But it additionally served as a mannequin for what, maybe, may very well be attainable in every single place to protect in opposition to the unfold of the illness.
“This was a gift and an opportunity,” mentioned San Miguel County spokesperson Susan Lilly.
That was the unique plan, anyway. But on Tuesday, the grand experiment with daring aspirations appeared to disintegrate. Lilly put out a press release saying that testing was being “delayed indefinitely due to United Biomedical Inc.’s reduced ability to process the tests due to the COVID-19 pandemic.” Lilly declined to touch upon the choice.
The check that Hu and Reese’s firm had promoted as “fast — results in two hours” had slowed to a digital halt. The firm had initially advised the county to anticipate outcomes inside 48 to 72 hours after the samples arrived on the firm’s New York lab. Results from exams performed March 26 and 27 had been announced April 1, however outcomes from subsequent exams have nonetheless not are available.
A San Miguel County Department of Public Health and Environment press launch quoted an organization assertion that blamed the delay on operations and the majority of staff being positioned in New York, the place the pandemic has hit particularly arduous. The press launch issued Tuesday mentioned the corporate is aiming to renew processing the estimated four,000 excellent exams from the primary spherical of testing.
But with solely a fraction of the leads to to this point, and extra testing in query, the COVAXX testing seems to be one more instance of the chaotic response to the coronavirus disaster gone improper.
A Different Kind Of Test
The check that Hu and Reese donated to the Telluride neighborhood is an antibody check developed by COVAXX, a newly shaped subsidiary of their New York-based United Biomedical. It’s one among greater than 30 commercially accessible exams with out Food and Drug Administration approval beneath flexible rules adopted to handle the COVID-19 pandemic. So far just one antibody check has acquired official FDA approval — a test made by Cellex, which makes use of only a pinprick of blood and produces leads to about 15 minutes.
Antibody exams are essentially totally different than the CDC swab exams at the moment used to make official diagnoses. Where the swab check appears to be like for the virus’s genetic materials to find out energetic infections, an antibody check appears to be like for antibodies in an individual’s blood that present an immune response to the virus that causes COVID-19. Robert Garry, a virologist at Tulane University School of Medicine, mentioned the check can’t inform whether or not the particular person is at the moment sick or infectious.
The plan in Telluride was for members to be examined twice, two weeks aside, with the COVAXX check as a result of it may possibly take some time for somebody contaminated to indicate up as optimistic when measuring antibodies.
The COVAXX website claims its check has 100% sensitivity (that’s the check’s capacity to search out antibodies to the virus) and 100% specificity (a measure of how good the check is at differentiating this novel coronavirus’ antibodies from different antibodies).
But, Garry mentioned, no check is ideal. And creating an antibody check for the virus being referred to as SARS-CoV-2 is “tricky,” he mentioned, as a result of it wants to differentiate amongst a number of seasonal coronaviruses. Furthermore, he added, the COVAXX check is a peptide assay, which he mentioned sometimes shouldn’t be very delicate.
“We know 100% is an almost impossible bar to reach,” Garry mentioned. “It kind of raises some red flags.”
In an interview with KHN earlier than the Telluride program stopped, Hu mentioned that “I always hesitate when I say 100%,” however she mentioned that the corporate validated the check in opposition to 900 samples collected earlier than the COVID-19 outbreak, with no false positives. She added the check additionally accurately produced optimistic outcomes from blood samples which have been verified as optimistic by means of different exams.
Theoretically, having antibodies to SARS-CoV-2 might make an individual proof against the virus, however how strong this immunity is and the way lengthy it would final stay open questions. The massive promise behind testing an entire neighborhood is that if one can establish individuals who have been contaminated and recovered (or by no means gotten sick within the first place), one can safely ship them again to work or out in the neighborhood, Reese mentioned.
“It’s absolutely my goal to make this standard for how we get the country back to a new normal,” Reese had mentioned earlier than the check was suspended. “If we tested everyone in the whole country and were prepared to do it twice, you would know exactly when you would be back at functioning — everybody back at work.”
Reese isn’t alone in his pleasure. Hedge fund billionaire Bill Ackman invested an undisclosed quantity of capital into COVAXX by means of his Pershing Square Foundation, and bestselling writer and XPrize founder Dr. Peter Diamandis is listed as a part of the COVAXX leadership team on the corporate’s website. Diamandis presents a fawning interview with Hu and Reese in a broadly shared YouTube video, which doesn’t disclose his relationship with the corporate. Neither responded to requests for remark.
Testing Results
In all, about 6,000 of San Miguel residents had been examined at three areas throughout the county, which covers about 1,300 sq. miles. As of Monday, just one,631 of the exams had been processed, with eight (zero.5%) of them deemed optimistic, 25 (1.5%) “borderline” and 1,598 (98%) damaging. Borderline outcomes point out the particular person could also be within the early levels of manufacturing antibodies, Lilly mentioned.
Yet the one exams alone can’t present a transparent image of how many individuals have been uncovered.
As of Thursday, a complete of 11 circumstances in San Miguel County had been recognized with customary swab exams. Officials proceed to advocate that each one residents observe social distancing and that these experiencing signs observe additional isolation to forestall the potential unfold of COVID-19.
One method to take a look at this try at large-scale testing is that “everybody’s getting together and trying to do something cooperative and innovative,” mentioned George Annas, director of the middle for well being regulation, ethics and human rights at Boston University School of Public Health.
“If you wanted to be cruel, you could say this is a publicity stunt,” Annas mentioned.
The program actually received COVAXX loads of good publicity, together with gratitude from native residents — a minimum of initially.
And a resort city in Wyoming is following go well with. John Goettler, president of St. John’s Health Foundation in Jackson, mentioned his group is spending “less than $20,000” on COVAXX exams for about 500 well being professionals and first responders. Goettler mentioned Jackson resident Dakin Sloss, a hedge fund proprietor listed as one other member of COVAXX’s management crew, helped safe the exams. Testing is about to start subsequent week, and the check might be processed at an area lab, somewhat than in New York.
But in Ouray County, adjoining to San Miguel County, officers determined in opposition to such testing even earlier than the Telluride suspension.
The price “would shoot a hole in my budget for at least the next two years,” mentioned Ouray County public well being director Tanner Kingery.
But that wasn’t the one concern, Kingery mentioned. It would have required a big provide of treasured masks and different private protecting tools, he mentioned, whereas doubtlessly exposing well being care employees and neighborhood members to the virus.
Dr. Andrew Yeowell, an emergency room doctor and Ouray County EMS medical director, additionally was involved that damaging exams may give folks a false sense of safety. If folks with damaging exams felt emboldened to exit in the neighborhood and work together with others, he mentioned, it might undermine the county’s advisory to remain house.
“If you’re having symptoms or feel sick, stay home,” Kingery added. “That guidance doesn’t really change if you have a positive test.”
