As Test Iowa finishes its first week, the state is still trying to determine if its tests are accurate

Gov. Reynolds straightens papers at the April 30 press conference on COVID-19. — video still

One day before COVID-19 restrictions will be relaxed in 77 of Iowa’s 99 counties, Gov. Kim Reynolds said the state still hasn’t established whether the results from test kits used by Test Iowa are accurate. Reynolds, however, said she was sure the validation process, which is being conducted by the State Hygienic Laboratory at the University of Iowa, would eventually show the tests are reliable.

The governor revealed the information about the test kits at her press conference on Thursday in response to questions stemming from a Salt Lake Tribune investigation, published earlier in the day, that showed the COVID-19 testing by Nomi Health, the Utah-based tech company running Test Iowa, is producing a suspiciously high number of negative results in Utah.

During her prepared remarks at the press conference, the governor once again focused on justifying her decision to lift many restrictions in all but 22 counties, even though a report from the University of Iowa College of Public Health warned that easing restrictions at this time may result in a new wave of infections.

“COVID-19 isn’t going anywhere anytime soon,” Reynolds said. “The virus will continue to be in our communities, and unfortunately people will still get sick until a vaccine is available. Keeping businesses closed for weeks or months longer won’t change that fact.”

The UI report, commissioned by the Iowa Department of Public Health, didn’t suggest maintaining current statewide restrictions would eliminate the virus. It concluded, “Without such measures being continued, a second wave of infections is likely.”

But according to the governor, maintaining all statewide restrictions for another two weeks is “not sustainable. It’s not sustainable for Iowans, their livelihoods or our economy.”

“We must all learn how to manage the virus in the course of our daily lives.”

“Iowa’s expanded testing, case investigation and testing capabilities gives [sic] us the tools necessary to identify and isolate positive cases, track virus activity across the state and deploy targeted strategies to continue and manage it for the long-term,” Reynolds said.

But the state is relying on Test Iowa for its expanded testing, and as the Tribune reported, the accuracy of the tests Nomi is conducting as part of Test Utah, its first COVID-19 testing project, are being questioned.

According to the Tribune, “state data showing that the rate of positive results among people tested at [Test Utah] sites is less than half what it is for patients tested elsewhere in the state.”

Nomi CEO Mark Newman told the Tribune it was unfair to compare results of the Test Utah sites to other sites, because Test Utah had been testing asymptomatic people, which could account for the discrepancy in results.

(Nomi’s testing of asymptomatic people is a separate problem. Utah Department of Health guidelines require a person to have at least one symptom of COVID-19 before being tested, and Nomi continued testing people without any symptoms for at least two weeks after being told to stop by Utah health officials. More than half the people tested by Test Utah had no symptoms.)

But the Tribune also obtained data showing the results for just symptomatic test subjects. Test Utah sites reported only 2 percent of those with symptoms tested positive for the virus. Other sites, which were testing people with at least one symptom, reported an average of 5 percent testing positive.

In a statement, Nomi claimed that difference was likely caused by other testing sites not considering everyone with mild symptoms worthy of a test, therefore Test Utah may have been testing a wider range of people. According to the Tribune, Nomi didn’t provide evidence to support this claim.

Nomi is using test kits produced by Co-Diagnostics, a small company located in Salt Lake City. The tests reportedly have a “higher limit detection” than tests produced by larger companies, meaning more of the virus must be present in a sample before the test will detect it.

“An analysis by the life sciences publication BioCentury showed that at least 16 of 22 comparable tests authorized by the FDA report a lower limit of detection, or greater sensitivity, than Co-Diagnostic’s tests,” the Tribune said.

The limit of detection in the Co-Diagnostic tests is also higher than what the CDC recommends.

Reynolds was asked at her press conference what she knew about the accuracy of Nomi’s testing, and what statistics she’d reviewed regarding its results before awarding the company the contract for Test Iowa.

It was in response to those questions that Reynolds revealed the validation process for Test Iowa’s test kits is still underway. The governor did not say anything in her response about what information she reviewed before hiring the company.

Reynolds first learned about Test Utah during a phone call with Ashton Kutcher. The Cedar Rapids-born actor, who is friends with the CEO of one of Nomi’s subcontractors, said he thought Test Utah “looked very promising,” Reynolds said last week. Kutcher offered to put Reynolds in touch with his friend.

Reynolds was impressed enough by Test Utah to offer Nomi a $26 million no-bid contract to replicate it in Iowa. The governor did not consider any other company for the testing program before signing the contract, her spokesperson has confirmed.

Test Iowa’s online assessment site was launched last week, and last weekend its first drive-through testing site in Des Moines kicked off. On Wednesday, it opened a second drive-through site in Waterloo, and plans call for sites in Woodbury and Scott counties to open next week.

Iowa National Guard soldiers and a local health care professional operate a traffic control point at the COVID-19 testing site at the Iowa Events Center in Des Moines, Iowa, on April 25, 2020. — National Guard

The governor was asked on Thursday if she was confident the Test Iowa test kits were as good as kits made by other companies.

“They would have to be, because they were FDA approved,” Reynolds replied.

That FDA approval may not be as reassuring as it normally would be.

The Trump administration ordered the FDA to use emergency procedures, rather than the agency’s normal procedures, in deciding whether to approve COVID-19 tests. This has dramatically sped up the approval process, but has also resulted in some problems.

As Recode explained last week, “the lack of strict oversight from the FDA and real-world testing that would typically occur as part of the approval process has led to some tests having significant issues with accuracy.”

Even though the validation process for Test Iowa’s test kits is still underway, IDPH is already including Test Iowa results in its daily reports on testing totals, according to IDPH Deputy Director Sarah Reisetter. IDPH has no plans to indicate which of the results it reports are from Test Iowa sites, Reisetter said at the governor’s press conference.

The tests IDPH has been using at non-Test Iowa sites meet the CDC recommendations for virus detection limits.

On Thursday, IDPH reported another 302 Iowans have tested positive for COVID-19, including eight residents of Johnson County and 17 residents of Linn County. The new cases bring the state’s total number of confirmed cases to 7,145.

The Iowa Department of Corrections (IDOC) also reported more cases of the virus on Thursday. According to the IDOC COVID-19 page, another three inmates at the Iowa Medical and Classification Center in Coralville, better known as Oakdale Prison, have tested positive. Another staff member has also tested positive.

Six staff members and 18 inmates have now tested positive for COVID-19 at Oakdale.

IDOC reported the first confirmed case of the virus in a state prison other than Oakdale on Thursday.

According to a statement from the department, a male inmate at the Clarinda Correctional Facility in southwest Iowa tested positive for COVID-19. The inmate, who has been at Clarinda for several months, was placed in medical isolation on Saturday after he reported experiencing symptoms of the virus.

IDOC said it will be conducting additional testing at Clarinda.

IDPH reported on Thursday 14 more Iowans have died from COVID-19. The deceased include three residents of Linn County.

Newly reported deaths by county

• Dubuque County, 1 middle age adult (41-60 years)

• Linn County, 3 older adults (61-80 years)

• Marshall County, 1 middle age adult (41-60 years)

• Muscatine County, 2 older adults (61-80 years), 3 elderly adults (81+)

• Polk County, 3 elderly adults (81+)

• Scott County, 1 elderly adult (81+)

The state’s total number of COVID-19 fatalities is now 162, according to IDPH.

The 14 deaths on Thursday set a new one-day record for the number of reported deaths. The previous record of 12 deaths was set on Wednesday.

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