The Salt Lake Tribune is reporting that there may be problems with a coronavirus test out of Utah run by UtahTest.com. Basically, UtahTest is reporting less than half the positive test results as those performed with other tests in other parts of Utah. Why this might be bad enough for the residents of Utah who relied upon UtahTest, this same company is supplying test kits to Iowa and Nebraska, which are becoming hotspots for the coronavirus.
The accuracy of coronavirus tests by TestUtah.com has come into question, with state data showing that the rate of positive results among people tested at its sites is less than half what it is for patients tested elsewhere in the state.
And medical experts have been raising concerns about the effort, which has funneled millions of taxpayer dollars to the Utah tech companies running it here and in two other states. While Utah’s larger health care systems have relied on national names in diagnostics for their coronavirus tests, TestUtah has obtained its tests from a smaller Salt Lake City company and is processing them at a regional hospital in Orem.
Emboldened is mine.
So what are the questions with regards to UtahTest?
“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,” Bert Lopansri, a specialist in infectious diseases and microbiology at Intermountain Healthcare, wrote in an April 14 email that The Salt Lake Tribune obtained through an open records request after it circulated through state offices.
“A pandemic is not the time for amateurs to learn,” Lopansri concluded.
As of this week, TestUtah had eight testing sites around the state and had conducted tests on more than 18,000 Utahns, more than half of whom did not have symptoms of the coronavirus — despite state guidelines that only symptomatic patients should be tested.
The companies involved with creating and runnning this test are arguing that this is no big deal, and to compare their test results with those in other parts of the state is “not apples to apples.” They argue that of course they are going to have lower number of positive results because they have more asymptomatic people in their testing pool.
But according to state data obtained by The Tribune, TestUtah has reported test results for symptomatic patients separately — and even for those patients, positive results are far below those reported at other test sites in the state.
Some 2% of symptomatic patients at TestUtah’s sites have tested positive for coronavirus since April 1, according to the state’s data. That’s less than half of the 5% of patients testing positive at other Utah sites.
And scientists and doctors in Utah are criticizing UtahTest for failure to validate their test. For starters, the pool of those tested to validate the test should have been randomized and not selected from a group who have signed up for the test on the internet. Also, the limit of detection for UtahTest has come under question.
But the Co-Diagnostics test has a “higher limit of detection compared to tests offered by more established vendors,” Lopansri wrote, referring to the test’s sensitivity. A higher limit of detection means more virus is required in a sample to trigger a positive result.
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-Diagnostics’ tests.
Its limit of detection also is higher than that of the CDC’s test, wrote Dan Diekema, director of the infectious diseases division at the University of Iowa’s department of internal medicine.
“Based upon concerns I’ve heard from others re: test performance, it would be irresponsible to move forward without evaluating their test using sample exchange [with] Iowa’s State Lab. Or do all tests at [the state health lab],” Diekema said on Twitter. Diekema declined to comment further.
And is this becoming a potential problem or issue in Iowa? Govenor Reynolds had to address those concerns today in a news conference.
Bad enough that there is a lack of adequate testing for the coronavirus in the U.S. It would be worse if some states are relying on bad test to boot.