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U of I System Receives FDA Authorization for covidSHIELD Test Process


The University of Illinois System has received emergency use authorization (EUA)  from the U.S. Food and Drug Administration (FDA) for covidSHIELD, its innovative saliva-based COVID-19 test that was used on the U of I campuses to hold the virus in check by utilizing widespread testing with rapid results.

Under FDA guidelines, the EUA allows the U of I System to broadly expand its covidSHIELD testing beyond its universities.

“The University of Illinois has been a national leader in innovation for decades, and the campus’ groundbreaking work to develop rapid, saliva-based COVID-19 testing is but the latest example of that tradition,” said Gov. J.B. Pritzker. “My administration has been proud to work hand in hand with U of I since the earliest days of this development, which has had an enormously positive effect on keeping COVID-19 at bay in the U of I System, and we’re wasting no time in deploying this technology throughout the state. Even as we lead large-population states in vaccinations, widespread testing remains a critical tool in combating this pandemic, and I’m dedicating $20 million in CARES Act funding to provide one million tests to Illinois’ other public universities under the FDA’s emergency use authorization. I want to offer my gratitude to the scientists, researchers and healthcare workers at U of I who worked quickly to respond to the COVID-19 crisis, helping save lives and protect our neighbors throughout Illinois.”

The $20 million in federal Coronavirus Aid, Relief, and Economic Security (CARES) Act funding released by Pritzker will provide a million tests across the state’s 12 public universities and 48 community colleges, under an agreement between the Illinois Department of Public Health and the U of I System.

“Today’s EUA is a game changer in our efforts to combat COVID-19 across Illinois and the United States,” said U.S. Senator Dick Durbin (D-IL). “When the pandemic struck, the University of Illinois answered the call — and this rapid, low-cost saliva-testing program could be the key to dramatically expanding our testing infrastructure. I’m proud to stand with the remarkable work of U of I’s scientists and researchers, and I’m thankful for their efforts to improve our public health.”

U of I System President Tim Killeen said the system is eager to widely share the homegrown test, continuing a commitment to the public good that has been a part of the university system’s mission for more than 150 years.

“We were created to serve the needs of our state and our nation – to help steer through challenges and lead the way to progress,” Killeen said. “It is a role we have filled with distinction during the COVID-19 crisis, and this expansion of our breakthrough saliva-based testing will be a real game changer, protecting lives and livelihoods.”

The pioneering testing process, known officially as covidSHIELD, has drawn global interest since it was launched at the system’s three universities in 2020. To date, the U of I System has administered more than 1.5 million tests at its universities in Urbana-Champaign, Chicago and Springfield.

“This is gratifying news and a reason for celebration for all of the Illinois faculty and researchers who came together to invent a rapid, accurate testing process that could be deployed on a massive scale,” said Robert Jones, chancellor of the University of Illinois Urbana-Champaign (UIUC). “But what matters most to everyone here who was involved in the effort is the fact that this authorization gives people in every community in the country a new, affordable and accessible tool to protect those they care about from COVID-19. I want to thank Provost Andreas Cangellaris for the foresight to charge our faculty to create our own test, Vice Chancellor for Research and Innovation Susan Martinis for her unwavering support, and I want to thank the SHIELD Team leaders, Paul Hergenrother, Tim Fan, Marty Burke, Becky Smith, Nigel Goldenfeld, Sergei Maslov and Bill Sullivan, for developing our saliva test and building the SHIELD ecosystem.”

The system has created two units to share the testing protocol: SHIELD Illinois, which focuses on expansion within the state, and Shield T3, a university-related organization deploying the saliva test outside of Illinois.

“Interest in Shield T3 and requests for our help have been pouring in from around the globe,” said Bill Jackson, interim executive director of the Discovery Partners Institute, who works closely with the separate Shield T3 unit. “This important step simplifies the process of setting up labs and gives our partners added assurance.”

The million tests will be allocated based on a formula developed by the Illinois Board of Higher Education. Each university has determined how it will handle COVID-19 testing for the spring semester, as was the case during the fall, but SHIELD Illinois provides a proven option.

“Thanks to the excellent work by the University of Illinois and the UIUC SHIELD team, SHIELD Illinois and Shield T3 can use the test to make a real difference,” said Ron Watkins, managing director of SHIELD Illinois. “Coupled with the CARES Act funding that the Governor’s office and IDPH are utilizing to fund testing for public universities and community colleges, the EUA will propel our efforts to help Illinois reopen safely by providing testing for schools, businesses, and community partners.”

Samples from Illinois public universities that use covidSHIELD will be tested at labs across the state that have been authorized to use the covidSHIELD process. All labs using covidSHIELD are CLIA certified, meaning they meet federal standards for quality and reliability established by the Clinical Laboratory Improvement Amendments (CLIA) of 1988.

“This is an exciting and pivotal moment for the innovative test developed at the University of Illinois Urbana-Champaign,” said Jay Walsh, the U of I System’s interim vice president for economic development and innovation. “There is a huge need for accurate, fast and affordable testing to combat the pandemic, and we have invested in the ability to expand our covidSHIELD testing program beyond our campus communities — an investment that demonstrates the U of I’s commitment to the public good and to saving lives.“

Pioneered by a team of researchers in Urbana-Champaign, the covidSHIELD test requires only a deposit of saliva instead of an intrusive nasal swab. It takes minutes to collect the sample and provides results within 24 hours of the sample reaching a covidSHIELD lab. The test notifies individuals of the presence or absence of the genetic material contained in the SARS-CoV-2 virus.

Both SHIELD Illinois and Shield T3 can offer the test at a fraction of the cost of many widely available tests. In the clinical study for the EUA application, the covidSHIELD test was shown to be highly accurate.

Organizations inside Illinois who are interested in using the SHIELD saliva test should visit or email [email protected]. Interested organizations outside of Illinois should contact Shield T3 at or email [email protected].

This story was originally published by the University of Illinois Urbana-Champaign