The saliva-based COVID-19 test developed by University of Illinois researchers has obtained federal emergency use authorization, a highly anticipated stamp of approval that confirms its accuracy and enables broader distribution across the state.
The test, known as covidSHIELD, appeared on the U.S. Food and Drug Administration’s online list of approved molecular diagnostic tests on Monday. U. of I. has relied on the test to keep its three campuses open for in-person learning since the fall, garnering national attention for the innovation and running more than 1.5 million samples to date.
In a statement, Gov. J.B. Pritzker hailed the test as “groundbreaking work” and said he is “wasting no time in deploying this technology throughout the state.”
Pritzker has already allocated $20 million in federal relief funding to expand the saliva test to the state’s nine other public universities and 48 community colleges. The money will cover the purchase of 1 million tests to be divided among schools 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 (the saliva test) provides a proven option,” according to a U. of I. news release.
The U. of I. saliva test is praised for its simplicity: Participants fill a test tube with saliva, monitored by “trained observers,” but don’t need to see a medical professional for a nasal swab. The saliva sample is then analyzed at a lab, with results available on a phone app in about 24 hours.
The test is sensitive enough to detect even small amounts of genetic material, including mutations of the SARS-CoV-2 virus that originated in other countries, according to university officials.
At its flagship campus, where about 40,000 students returned for fall classes, undergraduates were tested at least twice a week and in-person faculty and staff also took weekly tests. The fast notifications are largely credited with helping the university isolate positive students before large outbreaks interrupted the term.
In addition to Urbana-Champaign, students in Springfield and Chicago could take the tests because they were developed and analyzed in state-certified campus labs. But the university needed federal approval to implement the screens at additional locations.
In its Feb. 24 approval letter, the FDA said it “considered the totality of scientific information available” and found the test “may be effective in diagnosing COVID-19.” The eight-page document also states that “negative results do not preclude SARS-CoV-2 infection” and “must be combined with clinical observations, patient history, and epidemiological information.”
Jay Walsh, U. of I.’s interim vice president for economic development and innovation, said emergency use approval allows the university to authorize labs across the country to conduct and process the tests, Walsh said.
He said he expects to resume conversations with local school districts, companies and other state entities that are interested in procuring tests. The test is already in use at some out-of-state universities and companies.
“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,” he said in a statement.
The tests also cost less than many alternatives. Shield Illinois, the university organization tasked with expanding the operation, said it will sell the tests for $20 to public school districts and public universities, $25 to private universities and $30 to companies.
Some lawmakers previously grumbled at the timeline. U. of I. unveiled the tests in August and applied for federal approval in December. The university erroneously believed it earned FDA approval in the summer but had to walk back those statements and officially apply for the designation.
echerney@chicagotribune.com
