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Pritzker: Federal U of I test approval has “potentially game-changing implications for our statewide testing program”

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Illinois

* The governor held a press conference to announce this breakthrough today…

The University of Illinois, Urbana-Champaign is now performing its new rapid, saliva-based COVID-19 test under the umbrella of an approved FDA Emergency Use Authorization. The CLIA-certified lab at the U. of I. performed a bridging study to a recently approved FDA EUA, showing that the Illinois test performs at least as well as the recently approved saliva-testing protocol.

“Direct saliva testing can address bottlenecks of time, cost and supplies. Our test also has unique features that enable fast and frequent testing on a large scale, and we are now working together with many partners to make our testing method broadly available as soon as possible,” said Dr. Martin Burke, a chemistry professor who helped to design the test. Burke also is the associate dean for research at the Carle Illinois College of Medicine and a medical doctor.

“Today’s news puts the University of Illinois and the entire state of Illinois on the cutting edge of testing innovation on a national level. And let me just say to President Killeen, the State of Illinois looks forward to being your biggest customer,” said Illinois Gov. J.B. Pritzker. “If ongoing research continues to yield positive results, this has potentially game-changing implications for our statewide testing program as well as for testing on a national level. I’m so proud — but not at all surprised — to see this type of groundbreaking work come out of our own University of Illinois and I want to applaud President Killeen and the entire research and development team at University of Illinois for this achievement.”

“This pioneering technology is a game-changer that will help safeguard lives and livelihoods across the country,” said Tim Killeen, the president of the University of Illinois System. “It is one of many breakthroughs that the U. of I. System’s world-class researchers have contributed to the battle against COVID-19, a battle that we are proud to help lead.”

Unlike most coronavirus tests, which involve a long, invasive nasopharyngeal swab, the Illinois-developed saliva test, called I-COVID, asks those tested to drool a small amount into a sterile test tube. The I-COVID test yields results in hours, even at high testing volumes: The U. of I. has performed more than 50,000 tests since making walk-up testing available to faculty members, staff and students in July, and expects to test up to 20,000 people a day when the fall semester begins Aug. 24.

“Once somebody is infected, the amount of virus in their system can rise very rapidly. Unless we have a test that can give them results very quickly, by the time somebody finds out they are infected, they will have spread the virus,” said Rebecca Lee Smith, a professor of pathobiology at Illinois. “The faster we can notify people, the faster we can stop the spread.”

The Illinois protocol has one key element that makes it uniquely suited for large-scale adoption, said Paul Hergenrother, a chemistry professor who helped to develop the test. “We inactivate the virus without opening any tubes. The samples are immediately inactivated at 95 C for 30 minutes. That makes it very safe for the workers in the diagnostic lab,” he said.

Testing is only one part of the strategy to contain the COVID-19 pandemic, the researchers note. The university has developed SHIELD, a three-pronged “target, test, tell” system that incorporates testing with data reporting, modeling and a smartphone app, working closely with the Champaign-Urbana Public Health District for contract tracing and isolation for individuals who test positive. The University of Illinois System recently announced the formation of SHIELD T3, aimed at making the testing and data technology broadly available.

Any other CLIA-certified labs that would like to use the I-COVID protocol can perform similar bridging studies to the FDA EUA granted to 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,” said Robert J. Jones, the chancellor of the Urbana campus. “This is a critical new tool that we believe will let communities scale up their COVID-19 testing capabilities more rapidly in ways that are more affordable. We’re proud to be the university that is home to a huge team of amazingly dedicated and talented researchers who came together so quickly to move this test from concept to use approval in just a matter of months.”

posted by Rich Miller
Wednesday, Aug 19, 20 @ 3:06 pm

Comments

Some good news from down here in the cornfields.

Comment by filmmaker prof Wednesday, Aug 19, 20 @ 3:11 pm
I-L-L
Fantastic news

Comment by illdoc Wednesday, Aug 19, 20 @ 3:16 pm
So proud of our university. This is a University deeply committed to their mission to service the public. Throughout COVID, instead of sitting back, they have absolutely sprung to life and worked to develop solutions to help our state and nation. From the Illini RapidVent ventilator, to the clinical trials at UI Health on treatments for COVID and now the Saliva test - we are blessed to have such committed people living and working in Illinois FOR Illinois. Way to go U of I!

Comment by Align-I Wednesday, Aug 19, 20 @ 3:21 pm
I-N-I
Now lets see how quickly they can scale up this testing statewide

Comment by Stu Wednesday, Aug 19, 20 @ 3:23 pm
So proud of our university. This is a University deeply committed to their mission to service the public. Throughout COVID, instead of sitting back, they have absolutely sprung to life and worked to develop solutions to help our state and nation. From the Illini RapidVent ventilator, to the clinical trials at UI Health on treatments for COVID and now the Saliva test - we are blessed to have such committed people living and working in Illinois FOR Illinois. Way to go U of I!

Comment by Align I Wednesday, Aug 19, 20 @ 3:24 pm
great news!

Comment by ETown60120 Wednesday, Aug 19, 20 @ 3:25 pm
Go Illini. Beat Harvard to market with our saliva test.

Comment by Donnie Elgin Wednesday, Aug 19, 20 @ 3:30 pm
Now let’s see it scaled up. This is very good news today.

Comment by Fixer Wednesday, Aug 19, 20 @ 3:38 pm
Kudos to the team at U of I involved with creating this and another reason why our institutions of higher education are so valuable.

Comment by Cubs Win Wednesday, Aug 19, 20 @ 3:40 pm
Love to see UIUC leading the way.

I-L-L… I-N-I

Comment by Oswego Willy Wednesday, Aug 19, 20 @ 3:40 pm
What’s CLIA?

Great news from the U of I.

You gotta luv the alphabet soup of higher-ed news releases.

Comment by Leigh John-Ella Wednesday, Aug 19, 20 @ 3:40 pm
“CLIA defines a clinical laboratory as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for: diagnosis, prevention, or treatment of disease or impairment. health assessments.

Comment by illdoc Wednesday, Aug 19, 20 @ 3:47 pm
Clinical Laboratory Improvement Amendments (CLIA)

Comment by Donnie Elgin Wednesday, Aug 19, 20 @ 3:51 pm
Testing is not our problem right now, contact tracing is.

Comment by Thomas Paine Wednesday, Aug 19, 20 @ 3:52 pm
That is the SHIELD part. And you are right, extremely important

Comment by illdoc Wednesday, Aug 19, 20 @ 3:54 pm
My Alma Mater came through once again. I hope that our members of the GA are paying attention to these kinds of breakthroughs when the budgets are being negotiated and appropriations are set.

Comment by illini Wednesday, Aug 19, 20 @ 4:02 pm
This is a specimen collection methodology, but if it is not a point of care test yielding a result, the specimen still needs to be sent to a CLIA lab to detect virus by an EUA approved laboratory test.

Comment by Johnnie F. Wednesday, Aug 19, 20 @ 4:06 pm
This is such good news. What good is a test when the results aren’t available for a week? Not much help for the grocery clerk or Uber driver. (or their customers)

Comment by notsosure Wednesday, Aug 19, 20 @ 4:19 pm
Great work by our flagship university. Well done.

Comment by 47th Ward Wednesday, Aug 19, 20 @ 4:40 pm
Any word if U of I will share this test with Illinois public universities outside its system?

Comment by Mugs Wednesday, Aug 19, 20 @ 4:55 pm
Bruce Rauner still trying figure out why funding research at state universities is so important.

Comment by Almost the weekend Wednesday, Aug 19, 20 @ 5:08 pm
@Mugs The Governor Tweeted: “We are already working to deploy this to more public universities across the state over the next weeks and months and exploring rolling this out to do testing for K-12 schools and even more testing at our long-term care facilities as well.”

Comment by Align-I Wednesday, Aug 19, 20 @ 5:26 pm
Thank you, Align-I. You’ve made my day.

Comment by Mugs Wednesday, Aug 19, 20 @ 5:35 pm
That’s great that it is an easier test and returns results more quickly, but was is the lab throughput? That Abbott 15 minute test was supposed to be a game changer and I haven’t heard about it much lately.

Comment by harp5339 Wednesday, Aug 19, 20 @ 8:44 pm
Great news but if the Harvard test can give at home results at a lower cost it will be more of a game changer and more accessible to the general public. Very critical that those that work closely with the public(long term care facilities especially) have the access to testing multiple times a week with results before they leave for work. I hope all doing research to get rapid reliable home testing perfected to get it to the general population as soon as possible are successful. We need something that is available to get the most infectious people diagnosed long before they start showing symptoms which by that time they could have possibly infected many around them. Go-ILLINI

Comment by Arock Wednesday, Aug 19, 20 @ 8:49 pm
Yale beat us to it by the way.

Comment by filmmaker prof Wednesday, Aug 19, 20 @ 8:51 pm
@ Thomas Paine -

Testing is not our problem right now, contact tracing is.

Testing is huge problem right now and it’s made contact tracing almost irrelevant. The problem is many, many test results are coming back after 6 and 7 days. Simply too long for people to stop doing what they are doing to see IF they are infected.

This test - adding tens of thousands of tests a day with quick results will make contact tracing actually possible. We would be better off testing 25k a people day with 24 hour turn around on results vs 40 k a day a make people wait four or five days.

THIS here is a big step forward to resuming parts of life. Areas with outbreaks can get a dispatch of 10 or 20 k tests and quickly find out who is really infected. That brings the R naught of virus back down below 1.

Comment by Cool Papa Bell Thursday, Aug 20, 20 @ 12:44 am
An important development. I’m proud of the U of I.

Comment by Illinoised Thursday, Aug 20, 20 @ 7:22 am
Wonderful news. Tanks for making my day today. Huge smile emoji.

Comment by Froganon Thursday, Aug 20, 20 @ 8:46 am
My colleague’s daughter is a student at U of I and got her test results in 6 hours.

Comment by Diverdown Thursday, Aug 20, 20 @ 8:52 am