U of I Coronavirus Test Had No Emergency Use Authorization: FDA

CHAMPAIGN, IL — University of Illinois officials last week quietly updated their website to clarify that the saliva-based coronavirus test the university has been performing on tens of thousands of students and staff has not received emergency use authorization from the U.S. Food and Drug Administration.

Gov. J.B. Pritzker and university leaders announced the validation of the rapid test six weeks ago, describing it as a potential game-changer.

According to an Aug. 19 news release, the university was performing the test "under the umbrella of an approved FDA Emergency Use Authorization," because its lab had "performed a bridging study" to an authorization granted to the Yale School of Public Health.

“The bridge to FDA Emergency Use Authorization is extremely exciting and important news for all of us in this pandemic,” it quoted Urbana campus Chancellor Robert Jones as saying.

Pritzker touted the new test at a news conference and later said in a tweet that the FDA had "given the green light under their Emergency Use Authorization powers."

But the FDA has not granted an emergency use authorization, or EUA, to the university's laboratory-developed test. And last month, FDA representatives asked university officials to stop characterizing it that way, the Chicago Tribune reported.

A university spokesperson told the paper it "conducted what we understood to be a bridging study." An FDA official suggested there may be confusion stemming from a misunderstanding of the term, according to the Tribune, writing in an email to the university, “Your test is not considered within the authorization of the Yale SalivaDirect EUA, nor has it received its own authorization from the FDA.”

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Some time between Sept. 17 and Sept. 25, the news release was updated to eliminate the language about "umbrella" and "bridging," according to an archived version of the release. It now says the university validated the test designed in its lab "by successfully comparing its performance to an FDA Emergency Use Authorized test." There was no acknowledgment of the update.

The spokesperson told the Tribune the saliva test has been conducted on about 40,000 people so far, and the university is continuing to seek FDA approval.

The test has been conducted more than 444,000 times as of Friday, with an average of about 10,000 tests every weekday, according to testing data from the university.

The high rate of testing has led to a coronavirus positivity rate below 1 percent. As a result, state public health officials this week separated Champaign County from Region 6, the surrounding COVID-19 resurgence mitigation region.

If the rest of the region exceeds 8 percent positivity for three straight days, sees rapidly increasing hospitalization or lacks available hospital beds, Champaign County will still participate in mitigation measures imposed on the region, according to the Illinois Department of Public Health.