False Insecurity: State Tries to Sort Out Manchester COVID-19 Testing Snafu 

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• Christine Glade
• Downtown Manchester

The "wave," as Dr. Janel Kittredge called it, started with a child's stomachache. That's not a typical sign of COVID-19, but the patient also had a fever, so Kittredge ordered a test. 

Unlike most doctors in Vermont, Kittredge didn't have to wait days for an answer. Her urgent care clinic in Manchester was able to process the swab in just 15 minutes, thanks to a new COVID-19 test the federal government had recently authorized.

This rapid antigen test is less accurate but much faster than the gold-standard method the state uses to diagnose the infection.

The child tested positive through the rapid antigen method on July 10, Kittredge said. The next positive was a man in his early fifties who had a sore throat, then a "fatigued" 75-year-old man who'd just driven from Florida. Manchester Medical Center set up an outdoor tent as word spread and more people streamed in. Within days, the tiny clinic had tallied 65 positive antigen tests.

Kittredge and her partners appeared to have discovered a major outbreak in an overlooked part of the state — and believed their rapid test had saved critical time in the race to contain it. 

"The virus is very much out there and floating through the community," Kittredge announced in a July 11 Facebook post reporting the first five positive tests. She asked her followers to share the news.

But when state health officials later ran the standard test on Kittredge's patients, the results told a very different story: Just four of the 52 people retested as of July 21 had positive results. And when the state tested another 1,613 anxious southern Vermont residents at pop-up sites that were set up in response last week, it got only one positive result. There was no outbreak in Manchester.

The discrepancy has pitted cautious state health officials against a defiant local doctor in a tussle for public trust. The resulting confusion threatens to undermine confidence in coronavirus tests just weeks before communities must count on them to safely reopen schools. 

Testing a Niche

For two crucial months in the spring, it wasn't easy to get a COVID-19 test in Manchester. The three nearest hospitals are each 30 minutes away, and the hospital-affiliated clinic in Manchester Center hasn't offered them. 

A similar dearth of access to emergency care meant that residents were excited last July when Kittredge and her husband, Dr. Tom Sterling, opened their walk-in clinic. The couple are emergency medicine doctors who have worked in ERs and served as medical directors for regional ski resorts. Kittredge also manages a skin care practice, Sterling Aesthetics, which offers anti-aging treatments and Botox. Sterling is the Town of Manchester's deputy health officer.

Starting in early March, Manchester Medical Center prodded the Vermont Department of Health for test kits, but seven times it was directed to the University of Vermont Medical Center, which provided just a dozen or so. "Serving primary care providers is not yet part of our algorithm" for distributing test kits, health department spokesperson Ben Truman explained.

In early May, the U.S. Food & Drug Administration gave "emergency use authorization" to San Diego-based Quidel to distribute its rapid antigen test. Manchester Medical Center leapt at the new option, even though Vermont officials did not, and the state has yet to publish guidelines for how the tests should be administered.

Rapid antigen tests, also used to diagnose strep throat and influenza, look for specific proteins on the surface of a virus. These markers are reliable; if properly detected, the proteins' presence is a strong sign of infection. But sometimes the tests miss them, leaving an infection undiscovered. 

This risk of "false negatives" is lower for the conventional polymerase chain reaction, or PCR, tests typically used to diagnose a coronavirus infection. Still, some hospitals and other health care providers around the country have adopted antigen tests because the samples can be fed into a small machine that quickly spits out a result. The Trump administration plans to send thousands of them to nursing homes in hard-hit areas later this month.

Manchester Medical Center was the first to use Quidel's test in Vermont in late May, charging $65 per swab. (PCR tests in Vermont are generally offered without cost.) The short processing time proved attractive to travelers who sought to end their state-mandated quarantine period early. The Town of Manchester referred several of its employees there for that purpose, town manager John O'Keefe said. 

Kittredge initially told Seven Days that her clinic performed close to 700 negative tests over the first six weeks using Quidel's equipment. She later said in a broadcast interview that her team had performed 284 tests during that time. When asked about the difference, she said the figure she'd provided to Seven Days was wrong.

Alarm Bells

The Town of Manchester has taken a proactive approach to the pandemic. Its selectboard passed an indoor mask mandate in early June, and the local government has distributed roughly 9,000 masks to its 4,400 residents. The state had reported just seven total cases there before the July 4 weekend. 

But as Kittredge watched the holiday bustle, she saw a town that had let down its guard. The following weekend, several seemingly unconnected people walked into her clinic and tested positive for the virus.

By July 13, the clinic had recorded 35 positive antigen results. The doctors took the worrisome news to Sterling's colleagues at the town, but rumors were already spreading, fueled in part by Kittredge's earlier social media post. "Hysteria was setting in," O'Keefe said. O'Keefe emailed a regional contact at the health department at 2:13 p.m. looking for input. After 30 minutes passed with no reply, town officials decided to publicly "confirm" the cases in a Facebook post from the government account. 

State officials, wary of the antigen tests, had not considered the cases "confirmed," but O'Keefe said he felt an ethical obligation to make the information available as soon as possible, in the event it might save lives.

Many local restaurants and retailers quickly shut down. Summer camps were postponed. The Thursday farmers market was canceled.

It all made sense to Kittredge, who believed that Vermonters had been cruising on a false sense of security. 

"Every state around us has been on fire: New Jersey, New York, Massachusetts, Connecticut," she said. "Why would we not be? The only reason we're not is because we haven't been testing."

In fact, Vermont has a relatively high overall rate of testing, and the states Kittredge cited have not experienced the same recent surges as southern states. But how else to explain the sudden rush of positive cases, after weeks of almost entirely negative results? 

Dr. Timothy Brewer, a professor of medicine and epidemiology at the University of California Los Angeles, who specializes in infectious diseases, offered one possible explanation in an interview with Seven Days: The test processing kits or the countertop analyzer equipment could have become contaminated. Before doing anything else, Brewer said, "I would probably be calling my machine representative and having them check my kit."

Manchester Medical Center executive director John Mallard said he didn't think twice about the initial spate of positives. "It's super easy," he said of the processing, citing the clinic's experience with the machine to test for other illnesses. He said he did call his Quidel rep sometime last week, after the health department publicly questioned the results.

When Seven Days asked test maker Quidel for comment last Friday, a spokesperson said the company was unaware of an issue in Manchester and declined further comment.

"Can you please share with us the name of the Urgent Care sites," he wrote in an email, "so that we are able to follow up?"

Positive or Negative?

State health officials scrambled to respond to the publicized cluster of cases while also trying to verify the extent of the spread. Kittredge's clinic hadn't run the PCR test alongside the rapid antigen version for many of its patients, saying it didn't have enough kits. Kittredge said she didn't want to "waste" limited backup tests on positive patients, because the antigen test is not known for producing false positives.

The state's retests were expected to find more infections by presumably catching cases that the rapid antigen tests missed. Instead, the results that trickled in were head-spinning. Last Thursday, officials reported that only two of the seven PCR test results they'd gotten were positive.

The evidence was enough for Health Commissioner Mark Levine last Friday to state that the private clinic's cases appeared to be "false positives." He sought to reassure residents that the state had found no evidence of uncontrolled community spread.

Kittredge took umbrage, saying the state's skeptical approach to the antigen results merely sowed fear and distrust.

"Oh, my God, it's been an absolute dumpster fire," she said. "I fear for the fallout as a result of that, because people now don't trust the system."

She also critiqued the Southwestern Vermont Medical Center in Bennington in an all-caps-laced Facebook post over a statement it put out describing antigen tests as less accurate than the PCRs offered at the hospital. "If you tested POSITIVE, you are POSITIVE!" she wrote, hours before the first retests came back negative.

O'Keefe said residents' confusion over the nuances and uncertainties in testing have sprouted conspiracy theories that the health department might disavow the antigen cases to keep the state's overall case count low. It should report those results, too, for the sake of "transparency," he said.

Other states that have reported combined test results have faced pushback from scientists who say it blurs the overall picture. Dr. Jennifer Nuzzo, associate professor and lead epidemiologist at Johns Hopkins University's COVID-19 Testing Insights Initiative, said, "I can't imagine that we'll ever fully rely on rapid antigen testing without doing confirmatory PCR."

At a press conference Tuesday morning, Levine reported that he'd spoken with a health official in Maine, where a series of asymptomatic people had tested positive using the same rapid antigen testing kit but had tested negative on a subsequent PCR test. He said these two incidents may help guide scientific knowledge of "some kind of systematic error that's occurring with this testing" — and determine how rapid antigen testing should be used going forward.

The sources of public confusion have already become the subject of finger-pointing. O'Keefe said it was unsettling to see area health care agencies "rowing in different directions." Southwestern Vermont Medical Center chief medical officer Trey Dobson said it was "unfortunate" that Manchester Medical Center and town officials made the tests public before "trying to do a quick investigation."

The hospital plans to begin offering scheduled PCR testing at its Northshire Campus in Manchester Center this week.

"It's clear from this situation that responding by offering increased testing is the way to go," Dobson said.

No Answers

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• Christine Glade
• Northshire Bookstore door showing COVID-19 precautions and temporary closure due to suspected cases

The state health department has been exceedingly careful to avoid criticizing Manchester Medical Center. On Monday, Levine and Kittredge appeared for a joint interview on Vermont Public Radio's "Vermont Edition," where host Jane Lindholm sought to make sense of the convoluted situation. 

Asked about the potential source of the false positives, Levine noted that he would work with the Centers for Disease Control and Prevention and the FDA to understand what went wrong. 

He entertained the possibility, however unlikely, that the state's PCR tests were in error. Levine also raised the prospect of laboratory errors at Manchester Medical Center but quickly added that Kittredge's team had assured him that was "very unlikely."

Kittredge expressed doubt about the state's data. She floated a notion that PCR tests might not catch the virus if symptoms manifested in a patient's digestive tract. UCLA's Brewer told Seven Days the concept "doesn't make sense" unless Manchester Medical Center was testing stool samples. In his on-air response, Levine conceded that "anything here is a possibility" before politely mentioning that both tests rely on nasal or oral swabs. 

"Even the viral transport media, I have questions about that," Kittredge pressed, suggesting a possible problem with how PCR samples are transported to the laboratory for processing. "These are just questions. I don't have answers. I may be way off base. I have no idea," she said.

By the time the radio program reached the end of the noon hour, its host hadn't found much clarity. 

"I think there are still going to be a lot of questions in the community about the accuracy of testing and how to trust [the tests]," Lindholm said, cutting the conversation off.

Even as the controversy swirled last week, another Vermont provider, Springfield Hospital, began using antigen tests at its site, the health department said. Manchester Medical Center plans to continue using its antigen tests.

Others in Manchester seem to be moving on. Northshire Bookstore, across the street from the clinic, was one of several businesses that announced it would reopen this week.

Ventilator Drive

A big red banner across the Manchester Medical Center's home page solicits donations to a "COVID-19 Relief Fund."

The page links to an online donation form to the Manchester Medical Center Foundation, a 501c3 nonprofit formed by the urgent care clinic's co-owners, Thomas Sterling and Janel Kittredge, in May 2019.

They've previously described the foundation to local media outlets as an effort to help patients who can't afford care and a means to provide community health education. 

Recently, the clinic began promoting donations to the foundation as a way to help the clinic purchase "life-saving supplies," including ventilators, respirators and intubation equipment, and to fund the creation of negative-pressure rooms for COVID-19 patients. The website states that the clinic has raised $50,000 but hopes to raise $100,000 more.

Ventilators, used for the most dire COVID-19 cases, are typically found in hospital intensive care units, not urgent care clinics. Kittredge told Seven Days in a series of text messages that the clinic has a portable ventilator that Sterling, her husband, can use if he needs to stabilize a patient's airway while they wait for transportation to an emergency room, which she noted is more than 20 miles away. 

"We had to ramp up when SARS-CoV-2 came on scene," she said. 

Susan Barrett, executive director of the Green Mountain Care Board, which regulates hospitals, said the website language is "very concerning." The yet-to-be-opened clinic, in 2016, tapped an exemption for doctors' offices used by most urgent care centers in Vermont and avoided the onerous "certificate of need" process overseen by the board.

As part of the paperwork, the clinic's lawyers said it would offer the same services as a typical family physician's office. "It will not hold itself out as an available option for care during a true medical, surgical or psychiatric emergency," the couple's attorney wrote.

Doctors themselves must be licensed to practice, but the State of Vermont does not license outpatient clinics such as urgent care centers. The clinic's online fundraising plea is ambiguous as to how the equipment might be used, David K. Herlihy, executive director of the Vermont Board of Medical Practice, noted in a statement.

"It is possible to transfer a patient who is on a ventilator, but normally one would expect that a patient in need of a ventilator would be taken to the hospital as quickly as possible as opposed to being given that level of care in a walk-in clinic," Herlihy said.

Kittredge told Seven Days that Manchester Medical Center has no plan to provide inpatient care and said using the equipment would be a "last resort."

"If I am trained and credentialed to intubate in the back of an ambulance or on the side of the road, why am I any less able to do so in a controlled building?" she asked rhetorically.

Correction,  July 23, 2020: The Manchester Farmers Market is open on Thursdays from 3 p.m. to 6 p.m. An earlier version of this story contained an error.