One morning two weeks ago, Megan Hunt woke up fearing the worst.
The novel coronavirus pandemic was surging in Nebraska, and the 34-year-old midtown Omaha resident was winded, short of breath, sore, and had digestive issues, she told The Daily Beast. She continued to self-isolate, let her 10-year-old daughter help with the cooking, and tried to get a COVID-19 test from her state’s brand new, seemingly high-tech mass testing initiative: TestNebraska.com.
But when she completed the online survey of symptoms, the site told her she didn’t qualify.
“I have spoken to many people who have had the same experience,” said Hunt. “I reported my symptoms honestly, and I was not selected for testing.”
The episode might be unremarkable in a country where COVID-19 testing has been a global laughingstock if not for two things: Hunt is a Nebraska state senator, and she wanted to verify that the state’s choice for a testing program was effective.
Hunt still doesn’t know if she ever had COVID-19. But she does feel confident that her state’s test regime, the bizarre brainchild of Utah “tech bros” with a surreal assist from Iowa native Ashton Kutcher, is “the Fyre Fest of coronavirus testing,” as she told The Daily Beast.
Hunt was one of four state senators—along with Machaela Cavanaugh, Carol Blood, and Rick Kolowski—who recently called on GOP Gov. Pete Ricketts to cancel the state’s $27 million no-bid contract with TestNebraska. The deal, for 540,000 diagnostic tests, was negotiated in approximately four days, according to internal government emails obtained by The Daily Beast. The contract was awarded jointly to Nomi Health, Domo, SafeLane Health, and Qualtrics—a group of primarily tech companies based in Utah. The testing itself was, in turn, supplied by Utah firm Co-Diagnostics.
That money might have been better invested in Nebraska’s existing and top-of-the-line public health infrastructure, the senators argued. Also concerning, said Hunt, were disparities in the test results themselves, which came under public scrutiny after local newspapers reported differences in results at TestNebraska and TestUtah compared to other local labs.
As of Sunday, TestNebraska had provided 2,358 tests, with 80 positive results, leading to a 3.4 percent positive rate for the tests compared to a 17.9 percent positive rate for those done through the state’s public health lab and hospitals in the state, according to The Omaha World-Herald. The disparity raised concerns among local officials that the TestNebraska tests might be resulting in false negatives.
Meanwhile, as of Friday, Nebraska had 9,416 confirmed cases of the novel coronavirus and 113 deaths, according to data collected by the state health department. A total of over 57,000 people had been tested out of the state’s population of 1.934 million people. States with comparable populations include West Virginia, where about 70,000 people had been tested, and Idaho, where about 34,000 people had been tested.
“As time goes by, we’re going to see that in our haste to do something we’ve failed Nebraskans,” Hunt said.
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Requests for comment from SafeLane Health were not returned this week. But a spokesman for Qualtrics said the survey technology company’s contract—unlike the others—was vetted in through “a public, competitively bid RFP run by the state of Utah, and each state used the same [master services agreement] negotiated by the state of Utah.”
Nomi Health, meanwhile, took serious issue with the comparison to Fyre Fest, saying in a statement on Friday morning: “We’re hard at work getting Nebraska back on its feet. Rather than watching Netflix, we invite the senator to come join us and be part of the solution.”
“Nebraska needed immediate access to scarce resources, high-quality testing equipment and an efficient process to get it right,” the statement continued. “We were able to deliver for Senator Hunt’s state on all three. It’s easier to knock down a barn than build one. So while Senator Hunt continues to grandstand and find ways to score cheap political points in the midst of this crisis, we’ll let our results speak for themselves and continue to work with the governor on providing access to free testing across the state.”
Nomi added that it had “supplied the state with over 200,000” tests “ahead of schedule,” which could theoretically test 10 percent of the state population.
Domo weighed in on Hunt’s claims, too: “We’re proud to be working with leaders who are basing decisions on data as they manage through this rapidly changing situation.”
And in a statement, Co-Diagnostics defended its tests, writing that their accuracy “has been isolated as a variable and multiple, independent evaluations of test performance continue to show a high level of accuracy on a consistent basis” despite the “observed anomaly in the rate of positives in at least two communities.”
Still, Hunt recalled on Thursday that she was suspicious of the contract from the jump, when it became clear that the companies had little in the way of local connections. Then Gov. Ricketts admitted he got the idea for the initiative from Iowa Gov. Kim Reynolds, who has said she learned about it from actor and philanthropist Ashton Kutcher, a “good friend” of Qualtrics CEO Ryan Smith, whose business is involved in multimillion-dollar deals in all three states. Kutcher has said he was simply using his admittedly vast connections to offer a creative solution to his home state during a rapidly evolving public health emergency, after seeing signs of the test initiative’s success in Utah.
Through a representative, Kutcher declined to comment for this story.
The TestNebraska.com website launched and invited residents to sign up on April 21. The same day, Gov. Reynolds revealed Iowa’s nearly identical contract, at $26 million. In the days after the contract was announced, Hunt emailed both the state’s Department of Administrative Services and the Governor’s Office asking to see a copy of the contract.
Hunt said she did not receive a response, and turned to an avenue normally used by journalists and watchdogs: a public records request.
In addition to the allegedly rushed contract and lack of transparency in choosing these four Utah-based tech companies, the test results themselves—the most important facet of the initiative—have come under public scrutiny.
According to previous reporting in The Salt Lake Tribune and the World-Herald, major concerns have been raised about the accuracy of the tests being used—and the method of collection at TestUtah and TestNebraska. Ricketts said the tests have been validated with a 95 percent accuracy rate, and in more than one analysis demonstrated 100 percent sensitivity and 100 percent specificity. But the Logix Smart Coronavirus Disease 2019 (COVID-19) Kit from Co-Diagnostics—the test being used in both Iowa and Nebraska’s initiatives—has a higher “limit of detection” (LOD) than most other coronavirus tests that received emergency-use authorizations by the FDA. Or at least that was the conclusion of an analysis by BioCentury, a science journal, cited by the Tribune.
Essentially, the idea is that they require more of the virus to trigger a positive test result than other kits.
“Patients who are infected with SARS-CoV-2 may not test positive, leading to a high rate of false-negative results” if an LOD is too high for a test, said Linda Carter, an information scientist at CAS, a division of the American Chemical Society that specializes in scientific information solutions. Conversely, if the LOD for a test is too low, “then contamination can become a major problem, as the test will detect the tiniest amounts of viral RNA, leading to false-positive test results,” she explained.
There’s “an art” to determining the right target for an accurate test, according to Carter, who cited a recent report from the American Society for Microbiology, which said that “there are a lot of nuances to consider” in the challenge of clinical sensitivity on these types of tests.
In any case, those numbers in Nebraska led to questions from local leaders about the disparity amid outbreaks at meat plants, in cities like Grand Island, and statewide. But Ricketts argued the difference was due to a wider pool of those being tested, including those who have no symptoms or work in high-risk environments like health care and meatpacking houses.
That rationale was at least in theory supported by Cary Gunn, the founder and CEO of Genalyte, which manufactures medical and surgical instruments and is in the midst of carrying out its own serology testing initiative in San Diego. Gunn said Thursday that at first blush, from the outside, the issue could easily be more of sample bias, lab issues, or other factors rather than “some intrinsic flaw” in Co-Diagnostics’ test.
Still, the disparity was also present at TestUtah, according to the Tribune. It reported that 2 percent of symptomatic patients tested positive through TestUtah, compared to 5 percent who tested positive at other sites in the state. Meanwhile, The Gazette in Cedar Rapids, Iowa, reported that one county in the state found that nearly 10 percent of the initiative’s test results were “inconclusive.”
Mark Newman, founder and CEO of Nomi Health, is reported to have said that comparing TestUtah’s results with those of other local sites is “not apples to apples,” a sentiment echoed by Brent Satterfield, the chief science officer of Co-Diagnostics: “We’re talking about population differences.”
“Given the fact that the data demonstrates consistent, highly accurate test results eliminating our test as the primary factor, we would be interested in learning the results of research by epidemiologists, virologists, and others exploring other factors that may include patient population, self-reported symptoms vs clinician evaluated symptoms, demographics, and geographies, etc., to understand how this novel virus is behaving in the human body and in our communities,” Co-Diagnostics said in a statement.
Nomi Health, in a separate statement, argued that the lower positive rates in Utah were a “natural” result of self-reporting by patients with mild symptoms who may have not been able to qualify for testing at other sites, adding that the “tests being used by the State of Nebraska have been fully validated for accuracy inside of their lab environments.”
“All testing is conducted within CDC guidelines,” according to Nomi Health.
But patients in both Nebraska and Iowa have also reportedly complained of long delays in getting test results, beyond the 48 hours they were originally promised. According to the Tribune, some patients in Iowa have waited as long as 17 days. Hunt said others haven’t been able to make an appointment or get through to the hotline.
Ricketts has acknowledged previously that demand for the new tests overwhelmed multiple sites in the early days of the rollout and overloaded the new hotline, which apparently did not have enough staffers to answer all the calls coming in.
“We just ask for Nebraskans’ patience as we go through this process,” Ricketts has said, noting that the state “will be verifying it to make sure it’s calibrated appropriately and testing our samples to make sure we’re getting it right.”
“It’s only been a week,” he said Thursday. “Be patient.” (Ricketts’ office did not respond to multiple requests for comment from The Daily Beast this week.)
Even before the TestUtah and TestNebraska sites were set up, local public health experts were ringing alarms in both states about being cut out of the effort to curb the outbreak.
“I worry about having tests routed to a small community hospital lab inexperienced with highly complex molecular testing that uses a test from an unknown company without much in vitro diagnostic experience,” wrote one specialist in infectious diseases and microbiology who sits on Utah’s task force on coronavirus testing, in an April 14 email to the deputy director of the state’s department of health. The Salt Lake Tribune obtained the email via an open records request.
The same dynamic was emerging in Nebraska, according to government emails obtained by The Daily Beast.
Shortly after Gov. Ricketts’ public rollout, Michael Harvey, president and CEO of the Syracuse Area Health hospital—which is located about 40 minutes east of Lincoln—emailed top officials at the state’s department of administrative services with a warning. The gist was that hospital laboratory directors across the state were “very frustrated at the state’s approach with this testing initiative and that it will make it harder for established hospital laboratories to function,” as he put it. Harvey forwarded along an internal email among Syracuse Area Health officials worrying that the initiative would hinder private labs’ testing efforts. Jerel Katen, Syracuse Area Health’s lab director, wrote: “It looks like the state has the cart before the horse. I am getting very frustrated with the government’s competing for materials with the already established laboratory system.”
When reached Thursday, Harvey said the complaints in that email from the early days of the rollout were “no longer valid.”
“Then the COVID-19 situation was very fluid, a big surge of patients was expected, supplies were very short, and everyone was doing their very best to be as prepared as possible, including the State of Nebraska,” Harvey wrote to The Daily Beast. “In the weeks that have gone by since, those issues have been addressed and worked out.”
At the same time, Domo—one of the Utah-based software companies brought on in the testing deal—sent emails before the rollout, to congressional officials and even the state’s chamber of commerce, touting the TestNebraska initiative. The missives initially baffled some recipients, who appeared unfamiliar with the company and its efforts. Some were concerned they might be spam or illegitimate, according to internal emails obtained by The Daily Beast.
“Taylor, just making sure this is coming from your guys’ office and it’s not some secret Free Joe Exotic fund or something,” wrote Aron Wehr, a staffer for U.S. Rep. Adrian Smith (R-NE), in an email to Ricketts spokesman Taylor Gage. (In a statement on Thursday evening, Wehr said he “was not yet familiar with the organization who helped develop the social media campaign for the TestNebraska program when I contacted Taylor, and my email was a friendly request to determine whether it was authorized by the state government.”)
One thing we know for sure: The accuracy of these tests during a pandemic—and especially in a state where the governor never imposed a stay-at-home order—is paramount.
“Tests with high rates of false positives pose a major problem in that individuals who are led to believe they have had the disease, but have not really been infected, may take risks that could increase their exposure,” said Carter. “Likewise tests with high rates of false negatives allow for infected individuals—whether symptomatic or asymptomatic—who test negative to falsely believe they are safe and possibly not seek needed medical care or adhere to social distancing and potentially spread the SARS-CoV-2 virus to susceptible family members and other individuals.”
Complex though the science may be, Hunt felt this was a case of throwing public dollars at an admittedly urgent problem without taking enough time to think things through.
“I’m concerned that we’re not doing the best we can for the most people while being stewards of their money,” she said.
—With reporting from Adam Rawnsley.
