The search for a reliable COVID-19 test continues, Pitkin County Manager Jon Peacock told county commissioners during a meeting Thursday morning.
“Everyone is passionate about getting more testing capacity and community-based testing for Pitkin County, for the state and for the nation,” he said.
To that end, the county has partnered with a local medical advisory group. And when Englewood-based Aytu Bioscience announced Food and Drug Administration approval for its rapid-testing model that detects COVID-19 antibodies and delivers real-time results without having to send swabs to the state-run laboratory in Denver, officials rushed to ensure Pitkin County was at the top of the waiting list for 1,000 orders.
Since then, however, Aytu has not communicated with the county about a delivery date — and new data indicate that the tests, which take a quick blood sample from a finger prick, may detect more coronaviruses than just COVID-19, Pitkin County Chief Medical Officer Kim Levin explained.
“There’s this antibody test, this Aytu test, which is still unfolding. First, it has not been delivered as promised. Secondly, there’s not a lot of data on that specificity and sensitivity,” she said, referring to a test’s accuracy in detecting accurate positive and negative results.
“Now, there is some evidence that it has cross activity with the common cold, so what that means are false positives,” Levin continued. “There are four types of coronaviruses for a long, long time that cause a cold. They don’t kill people like this one does. Say I had a cold a year ago, my test may come back positive, and I don’t have COVID.”
Thus far, the county — and the state, for that matter — have utilized a swab-based model dependent on collecting specimens from patients and then transporting those specimens to the Colorado Department of Public Health and Environment lab in Denver. In addition to slow turnaround times for results and exposing health care workers to additional risk with limited personal protective equipment, or PPE, the accuracy of those test results is only 75-80%, she said.
“That nasal test, it’s about 80% — it’s called sensitivity, which means 20, or maybe 25 percent, false negatives,” Levin said. “That’s the danger of the false negative; we’d rather err on the side of being careful than the side of being careless, and with the false negatives, you risk running on the side of being careless. Despite that, the state moves on and is using that test because it’s the best one they have.”
Peacock echoed that statistic when updating county commissioners during a special work session on Thursday morning.
“With the swabs, you have a high false negative — one in four of the negative results may actually be positive,” he said. “What we’ve found is that even tests like the test that we were hoping to acquire from Aytu, the antibody test, may have some specificity issues with it, where it not only detects COVID-19 but may detect other coronaviruses, which could lead to high false positives.”
The reason for the discrepancy between initial hopes for the rapid tests’ accuracy — which were about 90%, Levin said — and actual evidence emerging is largely because of the FDA’s fast tracking COVID-19 tests and therapies, Peacock continued.
“That was one of those tests that was fast-tracked approved. One of the things we’ve learned is the specificity of that test is not what we had originally thought,” he said of Aytu’s rollout.
“What we’ve learned is we got very excited about some of the tests that were fast-track approved by the FDA, and that fast-track approval is not a full FDA approval; it does not come with all the data that the FDA typically requires in terms of its specificity — in terms of its accuracy with positives and negatives. As some of these tests are implemented, we’re learning some of that information,” Peacock said.
That doesn’t mean Peacock’s not acutely aware of the community demand for access to testing, he emphasized.
“Believe me, I wish I had 17,000 tests in a box sitting next to me. This is not the message we want to be delivering. You just need to be assured the team understands the urgency, the medical community understands the urgency, and doing it right’s important,” he said.
Until more accurate and increased availability to testing is a reality — “which it will,” Peacock said — the more stringent public health orders and social distancing mandates are essential in ensuring that health care burdens remain manageable.
In a community update meeting through the Incident Command Meeting on Thursday afternoon, Aspen Valley Hospital CEO Dave Ressler and Chief of Staff Catherine Bernard thanked the community for doing just that.
“Observationally, at the hospital, we are encouraged that we are still seeing relatively slight patient volumes associated with patients that have symptoms they believe may be associated with COVID-19,” Ressler said.
Since March 9, when the outbreak was substantively identified in Pitkin County, AVH has seen 20 patients present with COVID-19 symptoms, Ressler said, of which 18 were admitted and four were transported to higher-care, lower-altitude facilities.
“As you know, we’ve had two deaths in the community as well,” he said. Both casualties tested positive for COVID-19 after death, but neither sought medical attention from the hospital.
Ressler took the opportunity during the community update to give a sort of public service announcement reminding people of the hospital’s alternative respiratory tent, where people can get medical evaluations if they can’t self-manage symptoms but may not need immediate emergency care.
So far, “the tent” has seen between four and six patients per day on average, Bernard said, though hospital staff anticipates and is bracing for an increase in those numbers. Still, that’s less intimidating than a surge in emergency care patients.
“Four of those 20 patients have gone to a higher level of care, meaning they were intubated, on a ventilator and needing to get out of here. So far, we’ve been able to do that, but if you look at those numbers, that’s one in five,” Bernard said. “I’m not trying to scare anyone. The ER is open for business; we are managing these patients, but we are able to manage the amount we are getting because you are following these public health orders.”
Sheriff stresses compliance
Pitkin County Sheriff Joe DiSalvo, himself on his ninth day of self-quarantine after his wife displayed symptoms, said during the public update that law enforcement agencies will do what they can — from arrests to summonses to citations — to ensure the public continues complying with the orders.
“The four law enforcement agencies in the upper valley are cohesive in this,” he said of his office and the Aspen, Snowmass Village and Basalt police departments, which co-signed a letter to the community regarding enforcement plans.
“Many of you know us personally and understand and appreciate our community policing styles. Sadly, we’ve seen some behaviors that are incredibly thoughtless, as well as potentially dangerous,” he read from the letter. “We will not hesitate to arrest and summons individuals who make such poor choices that endanger fellow community members or first responders. This offense is a class 1 misdemeanor with penalties on conviction of up to 18 months imprisonment, or a $5,000 fine, or both.”