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Saliva Test Used by Loyola Gets FDA Emergency Use Authorization

Zack Miller | The PhoenixThe SHIELD Illinois COVID-19 test Loyola has been using to test students recently received the FDA’s stamp of approval.

The SHIELD Illinois saliva-based COVID-19 test Loyola has been administering to students for surveillance testing received emergency use authorization by the Food and Drug Administration (FDA) March 1.

The saliva-based test is administered to Loyola students and faculty based on the frequency of visits to campus.

Loyola originally decided to partner with the University of Illinois testing program for the spring semester because of the test’s accuracy and 24-hour turnover time, The Phoenix reported. It was also beneficial since the program gave Loyola the infrastructure to implement a large-scale testing and tracking program, The Phoenix reported. 

The saliva tests can also increase testing access and control spread by identifying pre-symptomatic and asymptomatic COVID-19 carriers, according to the SHIELD website.

Ben Taylor, the marketing and communications lead for SHIELD Illinois, said the program submitted its application Dec. 30 and received emergency use authorization Feb. 24. It was a thorough process in which the FDA reviewed data from clinical studies, collection and lab processes, and other materials, according to Taylor.

“This authorization shows that the U.S. government’s regulatory arm has reviewed all of our materials and agrees that our test is very accurate at detecting the genetic material of COVID-19,” Taylor said. “Some organizations have chosen to wait until we received the FDA EUA before they would use our test, so this will remove that potential roadblock for future partners.”

When the testing system was first rolled out at Loyola, the Wellness Center said the lack of FDA approval didn’t diminish the test’s accuracy but the health clinic had hopes it would receive emergency approval, The Phoenix reported.

The My SHIELD website states the test is non-invasive and doesn’t need someone medically trained to collect samples. It has an accuracy rate of 99.8-99.8 percent, with few false positives, which makes the test extremely accurate. 

Loyola offers the tests at Damen Student Center and Mundelein Center at Loyola’s Lake Shore Campus (LSC) and has administered more than 62,000 tests since July 2020, according to Loyola’s COVID-19 testing dashboard. 

Joan Holden, the director of the Wellness Center, said the university is pleased the SHIELD Illinois test has received FDA emergency use approval.

“Loyola University Chicago has been proud to partner with SHIELD Illinois to administer saliva-based testing on our campuses, as having a robust, community-wide surveillance testing program is critical to ensuring a safe on-campus experience for our community,” Holden told The Phoenix in an email. 

Holden said the testing process has been working smoothly thus far, and she expects this to continue throughout the rest of the semester.

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