The gunman was a 37-year-old man with a whose family had previously tried to take his guns away but found themselves without legal recourse to do so.

“We tried every legal avenue we could to not only protect him, but to protect the community,” said Douglas County Sheriff Tony Spurlock. At that time, however, there was nothing more they could do.

That changed with the passage of the Deputy Zackari Parrish III Violence Prevention Act, a “red flag” law that took effect in January 2020. It gives judges the ability to issue “extreme risk protection orders” allowing law enforcement to seize firearms from people deemed dangerous to themselves or others.

Colorado is among the most recent of 19 states to have enacted red flag laws. Connecticut was first, in 1999. Since then, the data has been mixed on whether the laws have prevented suicides and inconclusive on their power to curb mass shootings. The Connecticut law did not prevent the 2012 mass shooting at Sandy Hook Elementary School in Newtown, for instance, though proponents usually point to the laws as one tool for preventing shootings, not one that’s 100% effective.

But law enforcement officials who support the laws say they have clearly saved lives. A study looked at 21 cases in California in which extreme risk protection orders were granted from 2016 to 2018, and found that as of August 2019 none of the subjects of these orders had committed a murder or suicide, though it’s impossible to prove the orders prevented such outcomes.

The red flag law hadn’t been invoked in Colorado, the site of some of the nation’s most infamous mass shootings, when a gunman killed 10 people in a Boulder grocery store in March.

In Indiana, where a former FedEx employee shot and killed eight people at an Indianapolis facility before killing himself in April, under that state’s red flag law last year after the suspect’s mother reported to police that her son was suicidal.

Mass shootings may grab the most attention, but they are too rare to measure whether red flag laws help prevent them, said Rosanna Smart, an economist who studies gun violence at the Rand Corp.

The suspect arrested and charged with murder and attempted murder in the Boulder shooting had a history of violent outbursts dating back three years or longer, so it is hard to assess, while facts of the case are still being gathered, whether the red flag law could have been applied to him.

In 2018 the man pleaded guilty to third-degree assault after punching a fellow student at his suburban Denver high school in an attack the victim called unprovoked. He also was kicked off the school’s wrestling team after .

Police seized a shotgun from the Indianapolis shooting suspect after his mother reported in 2020 that she was worried her son, then 18, was considering “suicide by cop,” or deliberately provoking a lethal response by officers. An Indiana prosecutor told The Associated Press that authorities did not seek a hearing under the red flag law because they worried they would have to return the shotgun to him if they lost in court.

Most gun deaths in the U.S. are suicides, and Smart said about two-thirds of red flag cases regard somebody as at risk for self-harm.

Last April, Smart and her colleagues published a of research on the effects of red flag laws and found ”very inconclusive” evidence that they’re effective as a means to reduce overall firearm suicide or homicide rates.

“I wouldn’t say it’s strongly one way or another,” Smart said.

Aaron Kivisto, a psychologist at the University of Indianapolis, used a method called “synthetic control” to calculate that 10 years after the enactment of Indiana’s 2005 red flag law there was a 7.5% reduction in suicides compared with what would have been expected without the law, and the drop was driven exclusively by reductions in firearm suicides.

In Connecticut, the results were more of a “mixed bag,” Kivisto said. Initially, the effect was “negligible,” but the Connecticut law wasn’t used much until after the Virginia Tech shooting in 2007, in which a student killed 32 people and wounded 17. After that shooting, seizures in Connecticut and Kivisto’s group did then see a reduction in firearm suicides in the state, but they also found that those reductions were largely offset by increases in non-gun suicides. Still, taking all the studies together, Kivisto said, “The biggest takeaway is that the evidence supporting red flag laws as one means of reducing suicide appears to be consistently supported.”

Colorado’s are among the highest in the nation, but it’s too soon to know yet whether the state’s red flag law has made a difference, especially given how unusual 2020 was in so many other ways.

From Jan. 1, 2020, to March 26, 2021, Colorado tallied 141 red flag cases. Extreme risk orders were granted under the law in 28 of the state’s 64 counties, including some of whose sheriffs or county leaders opposed the law and declared themselves “Second Amendment sanctuaries,” where the law would not be enforced, said state Rep. Tom Sullivan, a Democrat. Sullivan, one of the bill’s sponsors, has been a gun control advocate since his 27-year-old son, Alex, was among the 12 killed by a gunman in the 2012 Aurora movie theater shooting.

Where the red flag law has been used in Colorado, “it’s clearly saved those individuals’ lives. Those people are still alive, and their family members are still alive, and they’re not in custody for homicide,” Douglas County Sheriff Spurlock said. “I do think it keeps my officers safer, and it keeps our community safer.”

But the law still has numerous opponents. Weld County Sheriff Steve Reams counters that situations like the one last fall in which an extreme risk protection order was approved for a 28-year-old man making plans to assassinate state Attorney General Phil Weiser should be dealt with using criminal charges, rather than a red flag law.

“Red flag, to me, doesn’t look like a primary way of dealing with a potentially criminal situation,” said Reams, who called Sheriff Spurlock a good friend with whom he’s repeatedly debated the issue.

As for people at risk of self-harm, Reams said he’d rather have better ways to get them mental health treatment than take their guns away.

Opponents of red flag laws say they’re unconstitutional, but a to Colorado’s law on constitutional grounds filed by the group Rocky Mountain Gun Owners and several Republican lawmakers was by a state District Court judge in Denver last spring.

Some opposition to Colorado’s law focuses on the execution, rather than the intent. Dave Kopel, an adjunct law professor at the University of Denver and an analyst with the Libertarian-leaning Cato Institute, has testified in favor of red flag laws in the Colorado legislature but is critical of the current law for what he says are weaknesses in due process.

“The accuser never has to appear in court or be cross-examined,” he said, and that means the judge may hear only one side of the case. “My view, as a constitutional law professor, is that you should write the law with strong due process protections at the start.”

But Spurlock, a Republican, said there is more due process in implementing Colorado’s red flag law than there is in police obtaining a search warrant. He said he supports gun rights but does not support allowing possession by felons or people who are a danger to themselves or others.

“That’s why I supported the red flag. And I will continue to do so. I know for a fact that it saves lives, and it’s not harming anyone,” he said.

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Here in Grand Junction, though, restaurants were open, and Hatfield had sought out those with the local health department’s “5-star certifications,” a designation meant to reassure people it is safe to patronize businesses during the pandemic. Those 5-star restaurants are part of an innovative program that allows businesses that agree to follow certain public health protocols to be open with less stringent rules than would ordinarily apply.

At a time when officials in parts of the nation are facing backlash from business owners who have been hurt by covid restrictions, Mesa County’s 5-star program encourages them to partner with the local health department to promote the directives.

Whether the approach boosts compliance with health directives remains to be seen. This largely rural county of 154,000 people on the Utah border is divided about covid protocols, with many still skeptical of wearing face coverings.

For example, Hatfield recalled a recent visit to a 5-star certified restaurant in Grand Junction where a party of four ignored a host’s request that they wear masks while waiting to be seated.

“I’m impressed with the 5-star program, but I’m not impressed with the level of mask-wearing here,” she said.

Mesa County public health director Jeff Kuhr and Diane Schwenke, president of the Grand Junction Area Chamber of Commerce, came up with the idea for the in June.

“It is a way of encouraging [businesses] to do the right thing, that they could then use as a marketing tool,” Schwenke said.

Businesses interested in the program fill out a form and the health department sends them a list of program requirements, which include mask enforcement for employees and customers, regular cleaning schedules, hand-sanitizing stations and spacing of furniture, Kuhr said.

The program launched in July with about 100 businesses, including restaurants, gyms and bars, and has since grown to around 600.

The Colorado Department of Public Health and Environment was so pleased with the Mesa County program that it unveiled in December, with to be approved. Officials in Utah, Michigan and Canada also have expressed interest.

“This whole event is about juggling viral suppression” while preventing economic devastation and the upheaval it brings to families and communities, said , executive director of the state health department.

The 5-star program has helped keep restaurants open despite rising covid numbers, but state officials are still analyzing data to see if it helps reduce spread of the virus, Hunsaker Ryan added.

In practice, public health isn’t just about medicine. It’s about politics too, said , professor and chair of the Department of Epidemiology and Biostatistics at the University of California-San Francisco. Though covid health directives have sometimes pitted business owners against public health officials, the 5-star program aims to unite the two.

“Ultimately, you have to deal with compliance not just with the hard hand of enforcement, but also with strategies that engage people in the goals of public health,” Bibbins-Domingo said.

Because participation in the program provides the opportunity to operate with looser restrictions on capacity and hours, businesses have incentive to comply, “even if they don’t think that the coronavirus exists — and we still have people here who believe that,” said Bill Hilty, medical director of the emergency department at St. Mary’s Hospital in Grand Junction.

“The program doesn’t impugn people who didn’t believe in covid or in masks,” Hilty said. “Their freedom was not infringed.”

Any business is eligible for the program, but it is especially appealing to gyms, restaurants and bars, which face restrictions on capacity and, in some cases, hours. For instance, Mesa County’s restaurant capacity limit under current covid rules is 25%, but eating establishments in the 5-star program are allowed to seat up to 50% capacity. Schwenke estimated that at least half the county’s restaurants have signed on.

The 5-star program has “absolutely saved us,” said , executive chef and owner of restaurants Bin 707 Foodbar, Taco Party and Bin Burger in Grand Junction.

Even so, he said, he has mixed feelings. The program allowed his businesses to remain open, but support in enforcing the rules has been minimal, he said.

Niernberg worries about the risk to his employees, who face “a daily struggle with anti-maskers” who visit his restaurants and demand to know why they’re being asked to wear a mask there, when other establishments not in the program don’t require them.

Even with the 5-star program, Bin 707 is operating at about a 20% loss each week, he said. Mesa County’s 5-star restaurants may be allowed 50% occupancy, but they’re also required to have 6 feet between tables. That spacing allows just 22% occupancy at Bin 707, Niernberg said.

In Mesa County, compliance is enforced by the honor system, reports from the public and occasional compliance checks by health department employees. About 10 establishments have been booted from the program for noncompliance.

Kuhr said his department does not release the names of businesses that have left the program.

On the face of it, loosening rules imposed to slow covid might seem like a bad idea, but if the 5-star program can produce better compliance with public health rules, it might be a good strategy for slowing the coronavirus, said Bibbins-Domingo of UCSF.

“I don’t want to dismiss the strategy, because buy-in is the holy grail in public health communication,” she said.

At the same time, when cases and community spread reach critical levels, as they did recently in Colorado and across the U.S., then at some point there’s a faulty logic to keeping businesses open, even with restricted hours, which may not do much to slow transmission. Density, on the other hand, “is very clearly related to transmission, so it’s the one thing I’d be very loath to ease up on,” Bibbins-Domingo said.

Whether the 5-star program would nudge businesses to accept public health directives or would simply be used as license to open was something considered as the program was coming together.

“We discussed this early on — who’s going to use this as a loophole and then not require masks,” Schwenke said. “We were worried about that initially, but the interesting thing is that this has seemed rare.”

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The two physicians from Houston had driven more than 18 hours to get here for the holiday weekend, and they were staying (and preparing meals) in a home. They traveled with another couple and their kids, colleagues they’ve been “bubbling” with in Houston.

“We got a COVID test prior to leaving and will get another when we return,” Naqvi said.

The skiing itself doesn’t feel much different during the pandemic, Eller said, but “the après ski scene is just gone.”

In March, at the beginning of the pandemic, Colorado Gov. Jared Polis issued an executive order requiring in response to COVID-19, which had hit the state’s ski towns early and hard. Now, as the resorts enter their busy season, the state has taken pains to avoid blanket closures even though cases of COVID-19 are reaching their highest levels yet.

How to stay open amid the pandemic is an issue resorts across the U.S. are facing. Mandatory face coverings have become the norm, but other COVID mitigation efforts vary by site. Vermont resorts their compliance with rules governing interstate travel during the pandemic when buying a lift ticket, and in Colorado’s Pitkin County (home to Aspen), visitors will be required to confirm they’ve had a negative COVID test result within 72 hours of travel or pledge to quarantine for 14 days after arrival or until they obtain a negative test result.

Telluride is an internationally renowned destination trying to operate safely while protecting the 8,000 or so permanent residents in the area. Located in a remote southwestern part of Colorado, its economy depends on tourism, and the resort posts as many as 6,500 visitors on its busiest days.

On Nov. 25, with its COVID case numbers and its positivity rate hitting 4.6%, San Miguel County, which includes Telluride, closed its bars and restricted its restaurants to takeout and outdoor dining only. Signs posted throughout the resort remind visitors of the “five commitments of containment” — wear a mask, maintain 6 feet of physical distance, minimize group size, wash hands frequently and, when you feel sick, stay home and get tested.

How bad would things have to get to close the resort? That’s hard to gauge, said Grace Franklin, public health director for the county. People are going to do what they will regardless, she said.

“If we shut down the ski resort, how many people will take to the backcountry and get injured or trigger avalanches where the impact is greater? It’s a ‘damned if you do, damned if you don’t’ situation,” Franklin said.

Instead, Franklin said, the question becomes “How do we create safer, engineered events so people have an outlet, but we minimize as much risk as possible?”

Skiing itself poses relatively little risk, said Kate Langwig, an epidemiologist at Virginia Tech. “You’re outside with a lot of airflow, you’ve got something strapped to your feet so you’re not in super close contact with other people, and most of the time you’re riding the lift with people in your group.”

Gathering in the lodge or bar is by far the biggest COVID risk associated with skiing, said Langwig, who grew up skiing in northern New York. “In my family, one of the things you do after a day of skiing is connect with friends and have a beer in the lodge,” and it’s this social aspect of skiing that’s too risky right now, she said.

In an effort to discourage tourists and residents from congregating, local governments, medical facilities and the ski resort released a in November urging people to cancel any plans to gather with those outside their immediate household and celebrate the holidays solely with people from their own household. Keeping the resort open will require everybody to do their part, said Lindsey Mills, COVID public information consultant for San Miguel County.

“We are not telling anybody not to come, at least not yet,” said Todd Brown, Telluride’s mayor pro tem. But local officials are broadcasting a strong message to everyone in the area — “Chill out. Don’t have the big party with five families.”

Officials aren’t worried only about coronavirus transmission; they’re also concerned about overtaxing their medical facilities. San Miguel County has an urgent care center but no hospital, and its medical center experienced a 22% staffing shortage at the end of November, mostly because so many employees are in quarantine. Hospitals in nearby Mesa County reached their ICU capacity , and other hospitals in the region are also pinched.

“We can’t have a situation where people break their legs on the slopes and we can’t get them care,” said Franklin.

The resort has taken steps to facilitate physical distancing among visitors. Reservations aren’t required at Telluride, but lift tickets must be purchased in advance, and the resort can restrict ticket sales if necessary, said Jeff Proteau, vice president of operations and planning at the Telluride Ski Resort. Gondolas are operating with the windows open and each load is restricted to members of the same household.

To reduce contact in and around the lifts, workers have created “ghost lines” of empty space to ensure a 6-foot distance between groups while they wait in lift lines. People from the same household can stand in line together and ride the two- to four-person lifts next to one another, Proteau said, but when riding a lift with someone from another household, guests are asked to leave a vacant seat between them.

Langwig was a children’s ski instructor for many years and worries about ski school. “You interact pretty closely with the kids,” she said, noting that runny noses are common. “You spend a lot of time getting kids bundled up and to and from the bathroom.” This could be especially challenging if indoor spaces are closed, she said. “Hot chocolate breaks are one of the ways you get kids through the day, and that’s not safe anymore.”

In anticipation of visitors needing to take breaks to warm up, the resort has installed six temporary structures around the mountain with insulated ceilings and heated panels. When the sides are rolled up, they’re considered outdoor spaces, Proteau said, but they can be closed into confined spaces with limited occupancy as needed, especially on a blustery day.

The risk for most employees on the mountain should be relatively minimal, Langwig said, at least at work. “Lift attendants are outside wearing thick gloves and a mask most of the time. Compared to someone who works in a restaurant, their risk is pretty low.”

Employees are generally assigned to work in small groups that can be quarantined, if necessary, without wiping out a whole department, Proteau said. There’s also contact tracing in place for resort employees.

Arizona native Joey Rague moved to Telluride last year and works as a ski valet on the mountain. He said there’s a huge incentive among employees to keep the resort open. With affordable housing sparse in Telluride, “all of us are struggling seasonally to be able to pay rent.”

So far, he said, most visitors have been respectful and conscientious of the rules.

“It seems as though people understand that if we want to stay open, we have to come together,” he said.

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So in April, when the Pitkin County Public Health Department announced it had obtained 1,000 COVID-19 antibody tests that it would offer residents at no charge, it seemed like an exciting opportunity to evaluate the efforts underway to stop the spread of the virus.

“This test will allow us to get the epidemiological data that we’ve been looking for,” director Gabe Muething said during an April 9 community meeting held online.

However, the plan soon fell apart amid questions about the reliability of the test from Aytu BioScience. Other ski towns such as Telluride, Colorado, and Jackson, Wyoming, as well as the less wealthy border community of Laredo, Texas, were also drawn to antibody testing to inform decisions about how to exit lockdown. But they, too, determined the tests weren’t living up to their promise.

The allure of antibody tests is understandable. Although they can’t find active cases of COVID-19, they can identify people who previously have been infected with the coronavirus that causes the disease, which could give health officials important epidemiological information about how widely it has spread in a community and the extent of asymptomatic cases. In theory, at least, antibodies would be present in such people whether they had a severe case, little more than a dry cough or no complaints at all.

Even more enticing: These tests were billed as a path to restart local economies by identifying people who might be immune to the virus and could therefore safely return to the public sphere.

But, in these and other communities, testing programs initially slated to test hundreds or thousands have been scaled back or put on hold.

“I don’t think these tests are ready for clinical use yet,” said University of California-San Francisco immunologist Dr. , who has studied their reliability. He and his team vetted 12 different antibody tests and found all but one turned up false positives — implying that someone had antibodies when they didn’t ― with false-positive rates reaching as high as 16%. ( is preliminary and has not been peer-reviewed yet.)

More than 100 antibody tests are currently available in the U.S., including offerings by commercial labs, academic centers and small entrepreneurial ventures. As serious questions emerged earlier this month about the accuracy of the tests and the usefulness of the results, the U.S. Food and Drug Administration said it will on their products and apply for  for their products. (Previously, companies were allowed to sell their tests without review from the FDA, as long as they did their own validation and included a disclaimer.) And the American Medical Association said on May 14 that the or when to end physical distancing.

And this week, the Centers for Disease Control and Prevention released  warning that antibody test results can have high false positive rates and should not be used to make decisions about returning people to work, schools, dorms or other places where people congregate.

Once hailed as a solution, the current crop of tests, which have not been thoroughly vetted by any regulatory agency, now seem more likely to add chaos and uncertainty to a situation already fraught with anxiety. “To give people a false sense of security has a lot of danger right now,” said Dr. the health officer for Teton County, which includes Jackson, Wyoming.

Accuracy Questions Raised

The gold standard for confirming an active COVID-19 infection is to take a swab from the nasopharynx and test it for the presence of viral RNA. The antibody tests instead parse the blood for antibodies against the COVID-19 virus. It takes time for an infected person to produce antibodies, so these tests can’t diagnose an ongoing infection, only indicate that a person has encountered the virus.

In Aspen, county officials knew the FDA had not approved the Aytu BioScience test, which the Colorado-based company was importing from China. So they first conducted their own validation tests, said Bill Linn, spokesperson for the Pitkin County Incident Management Team. “We weren’t reassured enough by our own testing to feel like we should move ahead.”

In Laredo, officials had been told by one of the community members helping to arrange the purchase of from the Chinese company Anhui DeepBlue Medical Technology that they were FDA-approved, but the city’s own validation trials revealed only about a 20% accuracy rate, said Laredo spokesperson Rafael Benavides. Before Laredo could pay for the tests, Benavides said, an arm of U.S. Immigration and Customs Enforcement seized them and launched an investigation.

Neither Anhui DeepBlue Medical Technology, nor Aytu returned requests for comment.

In March, Covaxx, a company led by two part-time Telluride residents, offered to test residents of the town and the surrounding county with an antibody test it had developed. But the project was suspended indefinitely when the company’s testing facility fell behind on processing them.

The county is committed to doing a second round of testing but is evaluating how to proceed, said San Miguel County spokesperson Susan Lilly. “The question is how do you target it to be the most relevant clinically and for the public health team’s decision-making moving forward?”

Officials Back Off, Community Members Step In

On May 4, the FDA to require that manufacturers submit validation data, but it is still allowing the tests to be sold without the , which includes .

In some wealthy areas, government officials had been offering free tests from startups with local investors. In Jackson, for example, a venture capitalist with an investment in Covaxx, the test used in Telluride, offered to help the city obtain 1,000 tests. But after reviewing the offer, Teton County declined over concerns about the test’s accuracy. “If a person tests positive, what does that mean? And is that useful information? We just don’t know yet,” Riddell said.

Covaxx spokesperson John Schaefer said in a statement that the test had been validated on more than 900 blood samples and is being reviewed by the FDA.

After Teton County officials decided against community antibody testing, a private nonprofit, Test Teton Now, sprung up to provide free COVID-19 antibody testing using the Covaxx test for roughly 8,000 people, about a third of the county’s residents. As of May 22, they’d raised $396,000 and tested 843 samples. The group has “done a lot” to verify the Covaxx tests, said Test Teton Now president Shaun Andrikopoulos. “I don’t want to call it validation, because we didn’t go through an independent review board, but we have sent our samples out to other labs.”

Organizers of Test Teton Now don’t share others’ concerns about the test’s utility. “We don’t encourage people to make any decisions about what they’re going to do or how they’re going to behave based on the results,” said the nonprofit’s spokesperson, Jennifer Ford.

What good is a test that can’t be used for practical purposes? “We think knowledge is power, and data is the beginning of knowledge,” Ford said. But unreliable data doesn’t give knowledge, it gives an illusion of knowledge.

So many unknowns remain, and false data may be worse than none. Even a very accurate test will produce a large number of false positives when used in a population where few people have been infected. If only 4% of people have actually been infected, a test with 95% accuracy would produce nine positive results for every 100 tests, five of which are false positives.

And that creates a danger that the tests could lead people to incorrectly think that they have antibodies that make them immune, which could have disastrous consequences if they changed their behavior as a result. Consider, for example, a person falsely told she had antibodies going to work at a nursing home, believing she couldn’t catch or spread the virus to anyone.

It’s not even known for sure that having antibodies makes someone immune. Researchers are hopeful that exposure can confer some level of immunity, but how strong that immunity might be and how long it might last remain unknown, said Harvard epidemiologist .

So, having been burned once, Aspen has put antibody testing on hold and is instead focusing on identifying and isolating people who are sick or at risk of becoming so. “It’s actually a step back to where we started,” Linn said.

Given the remaining unknowns about immunity and COVID-19, the best methods for addressing the pandemic in communities may be the most time-tested ones, Linn said. “Put the sick people in places where they can’t get anyone else sick. It’s the bread and butter of epidemiology.”

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While the Centers for Disease Control and Prevention’s tests for the virus that causes the respiratory illness have been in short supply since the outbreak began, this was a new type of test. It wasn’t to see who was sick right now. It was an antibody test that would assess who had been exposed and how widespread the virus was in the community to inform decisions about managing the outbreak.

When part-time Telluride residents and United Biomedical Inc. co-CEOs Mei Mei Hu and Lou Reese had offered to provide their company’s newly developed COVID-19 antibody tests for free to not just Telluride, but all of San Miguel County too, more than 6,000 of the county’s estimated 8,000 residents jumped at the chance.

“People really want to be part of it,” said Donna Fernald, a home health nurse who was tested the first day.

The widespread testing was an experiment in this community best known for its tony ski resort and summer music festivals. But it also served as a model for what, perhaps, could be possible everywhere to guard against the spread of the disease.

“This was a gift and an opportunity,” said San Miguel County spokesperson Susan Lilly.

That was the original plan, anyway. But on Tuesday, the grand experiment with bold aspirations appeared to fall apart. Lilly put out a statement announcing 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 comment on the decision.

The test that Hu and Reese’s company had promoted as had slowed to a virtual halt. The company had initially told the county to expect results within 48 to 72 hours after the samples arrived at the company’s New York lab. Results from tests conducted March 26 and 27 were April 1, but results from subsequent tests have still not come in.

A San Miguel County Department of Public Health and Environment press release quoted a company statement that being located in New York, where the pandemic has hit especially hard. The press release issued Tuesday said the company is aiming to resume processing the estimated 4,000 outstanding tests from the first round of testing.

But with only a fraction of the results in so far, and additional testing in question, the COVAXX testing appears to be yet another example of the chaotic response to the coronavirus crisis gone wrong.

A Different Kind Of Test

The test that Hu and Reese donated to the Telluride community is an antibody test developed by COVAXX, a newly formed subsidiary of their New York-based United Biomedical. It’s one of more than 30 commercially available tests without Food and Drug Administration approval under adopted to address the COVID-19 pandemic. So far only one antibody test has received official FDA approval — a , which uses just a pinprick of blood and produces results in about .

Antibody tests are fundamentally different than the CDC swab tests currently used to make official diagnoses. Where the swab test looks for the virus’s genetic material to determine active infections, an antibody test looks for antibodies in a person’s blood that show an immune response to the virus that causes COVID-19. Robert Garry, a virologist at Tulane University School of Medicine, said the test can’t tell whether the person is currently sick or infectious.

The plan in Telluride was for participants to be tested twice, two weeks apart, with the COVAXX test because it can take a while for someone infected to show up as positive when measuring antibodies.

The COVAXX claims its test has 100% sensitivity (that’s the test’s ability to find antibodies to the virus) and 100% specificity (a measure of how good the test is at differentiating this novel coronavirus’ antibodies from other antibodies).

But, Garry said, no test is perfect. And creating an antibody test for the virus being called SARS-CoV-2 is “tricky,” he said, because it needs to distinguish among several seasonal coronaviruses. Furthermore, he added, the COVAXX test is a peptide assay, which he said typically is not very sensitive.

“We know 100% is an almost impossible bar to reach,” Garry said. “It kind of raises some red flags.”

In an interview with KHN before the Telluride program stopped, Hu said that “I always hesitate when I say 100%,” but she said that the company validated the test against 900 samples collected before the COVID-19 outbreak, with no false positives. She added the test also correctly produced positive results from blood samples that have been verified as positive through other tests.

Theoretically, having antibodies to SARS-CoV-2 could make a person immune to the virus, but how robust this immunity is and how long it might last remain open questions. The big promise behind testing a whole community is that if one can identify people who have been infected and recovered (or never gotten sick in the first place), one can safely send them back to work or out in the community, Reese said.

“It’s absolutely my goal to make this standard for how we get the country back to a new normal,” Reese had said before the test 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 excitement. Hedge fund billionaire Bill Ackman invested an undisclosed amount of through his Pershing Square Foundation, and bestselling author and XPrize founder Dr. Peter Diamandis is listed as part of the COVAXX on the company’s . Diamandis presents a fawning interview with Hu and Reese in a widely shared , which does not disclose his relationship with the company. Neither responded to requests for comment.

Testing Results

In all, about 6,000 of San Miguel residents were tested at three locations across the county, which covers about 1,300 square miles. As of Monday, only 1,631 of the tests had been processed, with eight (0.5%) of them deemed positive, 25 (1.5%) “borderline” and 1,598 (98%) negative. Borderline results indicate the person may be in the early stages of producing antibodies, Lilly said.

Yet the single tests alone can’t provide a clear picture of how many people have been exposed.

As of , a total of 11 cases in San Miguel County had been identified with standard swab tests. Officials continue to recommend that all residents practice social distancing and that those experiencing symptoms practice further isolation to prevent the potential spread of COVID-19.

One way to look at this attempt at large-scale testing is that “everybody’s getting together and trying to do something cooperative and innovative,” said George Annas, director of the center for health law, 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 said.

The program certainly won COVAXX a lot of good publicity, along with gratitude from local residents — at least initially.

And a resort town in Wyoming is following suit. John Goettler, president of St. John’s Health Foundation in Jackson, said his organization is spending “less than $20,000” on COVAXX tests for about 500 health professionals and first responders. Goettler said Jackson resident Dakin Sloss, a hedge fund owner listed as another member of COVAXX’s leadership team, helped secure the tests. Testing is set to begin next week, and the test will be processed at a local lab, rather than in New York.

But in Ouray County, adjacent to San Miguel County, officials decided against such testing even before the Telluride suspension.

The cost “would shoot a hole in my budget for at least the next two years,” said Ouray County public health director Tanner Kingery.

But that wasn’t the only concern, Kingery said. It would have required a large supply of precious masks and other personal protective equipment, he said, while potentially exposing health care workers and community members to the virus.

Dr. Andrew Yeowell, an emergency room physician and Ouray County EMS medical director, also was concerned that negative tests might give people a false sense of security. If people with negative tests felt emboldened to go out in the community and interact with others, he said, it could undermine the county’s advisory to stay home.

“If you’re having symptoms or feel sick, stay home,” Kingery added. “That guidance doesn’t really change if you have a positive test.”

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