Staff Columnist

'Unusable' coronavirus tests results plague Test Iowa

Read to the end, because there is also a lawsuit

A medical worker gives a thumbs up to a resident May 7 after taking a sample for testing for COVID-19 at the Test Iowa s
A medical worker gives a thumbs up to a resident May 7 after taking a sample for testing for COVID-19 at the Test Iowa site at the Kirkwood Continuing Education Training Center in southwest Cedar Rapids. In the first few days of the site being opened, Linn County Public Health officials raised alarm over a high percentage of tests taken there without determined results. (Jim Slosiarek/The Gazette)
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When state Sen. Zach Wahls wanted to get tested for COVID-19, he filled out an online assessment through TestIowa.com, the public-private initiative to expand testing for the disease caused by the novel coronavirus.

The Coralville Democrat had just completed the legislative session where he’d been exposed to people who weren’t wearing masks and in situations where social distancing was nearly impossible.

He filled out the assessment and picked a testing time for June 18. The test was an nasal swab that Wahls said was very uncomfortable.

The results were supposed to come back in 72 hours. But they took over four days. And the verdict: His test hadn’t even been processed.

The email from Test Iowa stated, “Your test kit has arrived at the lab and has been determined to be unusable as an effective sample for a test. We sincerely apologize for this inconvenience.”

Wahls is one of hundreds of Iowans who had “unusable” Test Iowa test results last week. Stephen Pradarelli, a spokesman for the State Hygienic Lab, confirmed there was a spike in unusable Test Iowa tests the week of June 15.

“A large part of it was due to a malfunction of a piece of equipment in the lab used to process the tests; an issue that’s since been fixed,” Pradarelli wrote Wednesday in an email. “Another subset of the tests deemed unusable was based on leaked samples and SHL is taking steps to follow up on those issues as well.”

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A representative of Nomi Health, the company behind the Test Iowa program, commented: “... , a small number of Iowans were affected by an isolated issue at the lab last week and the State has been in touch with all those who were impacted. The issue has since been 100% resolved, and Nomi is collaborating closely with Dr. Pentella and his trusted team on an ongoing basis. This is an isolated incident that occurs in any program processing such high volumes of samples, and is not representative of the overall TestIowa experience. While any one damaged test is one too many, the TestIowa program has remained at an under 2 percent rate of unusable samples overall.”

But Nomi and the SHL not provide specicific data to quantify these numbers.

Molly Monk of Cedar Rapids is having trouble breathing. Her doctor recommended she be tested for COVID-19 but referred her to Test Iowa because she is not an essential worker.

Monk’s first test came back unusable and she immediately got retested. Three days later, she got two results back in two separate emails, one negative and one unusable.

Monk called the Test Iowa hotline for clarity but spent hours trying to get through to talk to a person. When she did, the answer she got didn’t make her feel more confident in the test.

“The woman I talked to said my test was negative, but there’s an error in the system that is sending out the ‘damaged test’ email again to people who had a damaged test last week. She said she’s had four or five calls from people with the same situation,” Monk said.

Wahls and several others I interviewed had the same problem: An unusable test, a retest, and two confusing results. Pradarelli said the lab was working with Test Iowa to look into the problem.

It’s not a new problem.

In May, Linn County Supervisor Stacey Walker noted that the number of inconclusive tests at the Linn County Test Iowa site was close to 10 percent. At the time, Pat Garett, a spokesman for the governor, denied that unusable tests were a problem and told The Gazette that the Test Iowa tests had closer to a “1 to 2 percent” rate of unusable tests.

This time, the state lab confirmed the problem, but hasn’t yet answered questions about the number of damaged or unusable tests.

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Molly Schintler, one of the many Iowans who had their tests deemed unusable, found the process infuriating.

She told me she had been exposed to the virus, but because she didn’t have any symptoms couldn’t get tested through her doctor.

The World Health Organization estimates that nearly 80 percent of people with COVID-19 experience mild symptoms or no symptoms at all. But these asymptomatic carriers can spread the disease to people more vulnerable. Because she’d been exposed, Schintler wanted a test. When she finally got one June 19 through Test Iowa, two days later she got an email saying it was “unusable.”

“When I go back to Test Iowa to get another test,” said Schintler, “I was crying because it hurt so much. The people administering the test told me I should just go to a different lab and get a blood test. But I tried. I spent five hours on the phone with the university to get an appointment and when I get an appointment, I am told I can’t get a test because there aren’t enough tests.”

Schintler also expressed frustration that nowhere on the Test Iowa website is there a place to reschedule or cancel appointments. “That’s a lot of inefficiency for a multimillion-dollar contract,” she noted.

Schintler also got retested and, like Wahls and Monk, got two results back.

“I hate this,” she told me in a phone call.

Test Iowa is an initiative with the state of Iowa and Nomi Health, a tech startup out of Utah. Nomi launched the Test Utah initiative in April and quickly expanded to Iowa and Nebraska. In each instance, the company signed multimillion-dollar no-bid contracts with the states, promising to provide tests, personal protective equipment and testing capacity.

But the initiatives have been plagued with trouble from the beginning. In Iowa, the tests and machines had trouble with the validation process. Anonymous reports out of the State Hygienic Lab expressed frustration with the backlogs. Those reports were later verified by the Governor’s Office and through emails about the program obtained through an open records request. On April 27, in one of those emails, Michael Pentella, director of the State Hygienic Lab, complained about Nomi Health, noting “the company is not supporting this as they should.”

The manufacturer of the test itself, Co-Diagnostics, say the tests have 100 percent sensitivity and specificity, two key markers for a test.

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But in Utah, the Salt Lake Tribune has reported that of the tests administered through Test Utah, only 2 percent have come back positive — while other state tests have a 5 percent positivity rate. In Nebraska, the Omaha World Herald reported the Test Nebraska positivity rate was 3.4 percent. That’s in stark contrast to the almost 18 percent positivity rate from other labs.

In Iowa, such testing data is unavailable. That’s because the state lumps in Test Iowa results with all the rest of the test results throughout the state.

The governor’s office, the Iowa Department of Public Health and the University of Iowa did not respond to multiple requests for the Test Iowa testing data.

Mark Newman, chief executive officer of Nomi Health, told the Salt Lake Tribune that the discrepancy is due to the fact that the tests target different populations. State tests are more likely to be given to people who exhibit symptoms, while the Test Iowa, Test Utah and Test Nebraska initiatives are supposed to be for anyone who wants them, healthy or not.

In a company news release on May 1, Co-Diagnostics chief medical officer stated, “In countries where we have been evaluated against other tests, we have consistently and repeatedly achieved 100% clinical sensitivity and specificity and you can’t do better than that.”

On May 4, at a news conference, Gov. Kim Reynolds stated, “I’m pleased to announce that the State Hygienic Lab completed the Test Iowa validation process yesterday, achieving high ratings of 95 percent accuracy for determining positives and 99.7 percent accuracy for determining negatives.”

While the numbers are not far off from Co-Diagnostics claim, every 1 or 2 percent of damaged, wrong or inconclusive tests can have far-ranging public health effects.

On June 15, a company out of the Cayman Islands filed a lawsuit against Co-Diagnostics, asserting the company is lying about the accuracy of its tests and engaged in a pump-and-dump stock scheme. The lawsuit argues that the 100 percent specificity and accuracy rate has been refuted by the Food and Drug Administration and other independent labs.

The spike of unusable results adds more doubt about the reliability of the tests.

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In response to the lawsuit, a spokesperson for Co-Diagnostics sent this statement, “Co-Diagnostics stands behind the quality of our technology platform, and performance of our testing products. We intend to vigorously defend this matter.”

The initiative meant to protect Iowans has lacked clarity and transparency from the beginning. But with the state lifting COVID-19 mitigation restrictions, each bad test result has the potential to become a huge health crisis.

And each unanswered question about the tests raises concerns about their accuracy. Iowa is already starting to see increases in cities and counties where people are going out to bars and restaurants.

State Sen. Rob Hogg, D-Cedar Rapids, who heard about the unusable tests from constituents, expressed concern about program.

“When you need accuracy, every mistake makes a difference for public health,” he said.

This story was updated to add a statement by Nomi Health.

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