Milwaukee Journal Sentinel

State’s coronaviru­s test kits fail checks

Hospitals still sending samples to CDC for diagnosis

- Madeline Heim

It’s been nearly a month since the Wisconsin State Laboratory of Hygiene received a kit from the U.S. Centers for Disease Control and Prevention that was meant to allow them to test for coronaviru­s on site instead of sending specimens to CDC headquarte­rs in Atlanta.

But after multiple state and local labs across the country sounded the alarm that the tests weren’t functionin­g properly, the state is still waiting for answers.

“This isn’t ideal, because we would like to be testing right now, but we do still continue to send specimens to the CDC,” said Allen Bateman, assistant director in the lab’s communicab­le disease division.

Shipping the specimens overnight has typically produced a one- to twoday waiting period for the pending tests.

After one Wisconsin patient tested positive for the new coronaviru­s and 15 tested negative, one more test was pending Tuesday, bringing the state’s total to 17.

The virus is still causing panic across the globe, as the number of cases has climbed over 80,000, with 2,700 deaths, and spread to 33 countries, according to the World Health Organizati­on.

Monday, CDC officials warned that outbreaks of the disease were likely to crop up in American communitie­s.

“We are very close to seeing this virus becoming a pandemic,” Melissa Nolan, a medical doctor and professor of epidemiolo­gy at the University of South Carolina’s Arnold School of Public Health, told USA TODAY on Tuesday.

The CDC acted quickly after the outbreak arose in China and spread across the globe to put testing capabiliti­es in the hands of state and local labs.

Bateman said the Wisconsin lab received its kit late in the afternoon on

Feb. 7 and began a series of practice tests the following Monday but quickly realized something was amiss.

The kit tests three segments of the virus’s genome, called N1, N2 and N3. In order for a positive or negative to be declared, all three segments need to show that positive or negative.

In the Wisconsin lab’s initial tests, though, the segments were showing mismatched results, meaning the test was inconclusi­ve. But lab workers knew that was off — they had manufactur­ed those sample specimens to be true positives and negatives.

They reached out to the CDC and within days were in communicat­ion with those officials, as well as the Associatio­n of Public Health Laboratori­es.

But in the last two weeks, Bateman said, it’s been fairly quiet, as the CDC races to figure out what went wrong.

They suspect it was a hitch in the manufactur­ing and distributi­on of the test. He’s been told they’ll perform more extensive quality controls on new batches of the kits.

“That’s why we do this verification testing any time we develop a new test,” Bateman said. “It delayed some things, but it’s a good example of why we do this.”

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