State Lab Continues To Double-Check Test Iowa Results

May 11, 2020

More than two weeks since coronavirus testing started through the Test Iowa initiative, the state is not relying on new equipment from that program to report out test results.

Six drive-thru sites have opened under the Test Iowa program, with a seventh planned for Ottumwa, but the State Hygienic Lab has not yet validated the equipment that is supposed to boost the state’s capacity for processing those tests.

“We’re getting really close to getting Test Iowa validated, so that will be a significant piece in allowing us to continue to ramp up our numbers,” Gov. Kim Reynolds said Monday.

IPR asked Matt Binnicker, director of clinical virology at Mayo Clinic and vice chair of practice in the lab medicine and pathology department, to explain the validation process for new diagnostic lab tests.

He said validation involves checking the accuracy and precision of new tests. 

“To do that, we take samples that have tested positive for COVID-19 by another emergency use authorized test, and we can demonstrate that the new test also generates the same results,” Binnicker said.

He said that’s the key component of lab validation, and they also try to show that they can get the same results when samples are “tested on different equipment or run by different lab techs over different days.”

A spokesperson for Iowa’s State Hygienic Lab confirmed Monday they are continuing to run the same samples through the newer Test Iowa equipment and the lab’s existing equipment to double-check the results.

Binnicker was on a team at Mayo Clinic that developed and validated its own coronavirus test within three weeks earlier this year. He said the validation process is different when you purchase the equipment from a diagnostic manufacturer, like Iowa did under the Test Iowa contract.

“When a lab decides to go that route, to buy the kits from a company, they then have to perform a validation in their lab,” Binnicker said. “But usually it’s a less stringent validation, less studies involved compared to developing your own test from scratch.”

Binnicker said if known positive samples are testing negative with the new equipment, that could point to potential problems. And if a lab wants to make changes to a test manufactured by another company, they would have to go back to that company and rely on them to make adjustments.

Utah-based Co-Diagnostics developed the new coronavirus testing equipment that was included in Iowa’s $26 million no-bid contract with Utah-based tech companies.

“[State Hygienic Lab] is working with the company as it does whenever it validates new equipment,” lab spokesperson Stephen Pradarelli said in an email. He added they are working to validate the testing materials (sometimes referred to as test kits) and the new PCR machines.

State officials have not said if they have encountered problems with the equipment. They have repeatedly said the process is routine. Pradarelli did not respond to IPR’s questions about how many samples the lab has run through the new equipment, the total number they want to reach, and what the rate of agreement the new test equipment has with the state’s existing equipment.

In a statement last week, State Hygienic Lab Director Michael Pentella said staff are working “24 hours a day, seven days a week” to keep up with demand from increased testing at long-term care facilities and meatpacking plants. He said they added staff and equipment to expand testing capacity.

Reynolds recently said she is confident in the accuracy of the Test Iowa after the Salt Lake Tribune reported on questions raised in Utah about the accuracy of coronavirus testing through the similar Test Utah program.

Utah has the same tech companies administering the program as Iowa and the same test manufacturer, Co-Diagnostics. One key difference is Utah’s tests are being processed at a small hospital, while Iowa’s tests are being processed at the state’s public health lab.

A statement from Co-Diagnostics confirmed they have worked with the Iowa lab, but declined to comment “on the Iowa lab’s stage of implementation.”

“Co-Diagnostics makes every effort to support the various government and private labs working to set up COVID-19 screening and testing capabilities and it is our understanding that the equipment is online and functioning as expected,” the statement reads.

Co-Diagnostics also provided a document they say shows the success of their tests.

Reynolds said Test Iowa is supposed to allow for an additional 3,000 tests per day in the state, to bring the total testing to 5,000 per day. In the past seven days for which data is available, May 4-10, Iowa averaged just under 2,700 tests per day, according to numbers publicly available on the state’s coronavirus information website.

Reynolds has said increasing testing through Test Iowa allows her to look at more granular data and supports her recent decisions to start to reopen the state’s economy. But the state has declined to say how many tests have been completed through Test Iowa.