The University of Illinois, Urbana-Champaign is now performing its new rapid, saliva-based COVID-19 test on all students, faculty members and staff. The university validated its laboratory-developed test under CLIA by successfully comparing its performance to an FDA Emergency Use Authorized test.
“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,” Martin Burke, PhD, associate dean for Research, Carle Illinois College of Medicine said.
Months before announcing this exciting news, researchers gathered to plan. Normal research onboarding can take months but the team rapidly responded to launch in just two weeks given the urgent need for more information about COVID-19 detection.
Carly Skadden, Clinical Research Manager, said that’s why ongoing partnerships with the University of Illinois are so vital.
“Since we know each other already and often work together, we can scale up quickly when needed.”
She said around 500 Carle patients donated saliva for the research study to help reach the Emergency Use Authorization goal.
“Patient participation in these types of studies helps to make the community safer. We’re so proud of our community members and patients’ willingness to be a part of the amazing achievement,” she said.
Carle’s role in the joint research project was an important behind-the-scenes effort.
In May, Carle clinical researchers assisted with obtaining patient samples, both saliva and NP swabs at the Carle COVID-19 drive through. They collected samples from patients with symptoms, patients needing testing before a procedure and those patients without any symptoms.
At that time, our community positivity rate remained very low so the study expanded to include hospitalized patients to help increase the number of samples collected.
“To validate the results, we had to shift our strategy to increase the number of samples,” Skadden said.
Jennifer Eardley, vice president of Research said Stephens Family Clinical Research Institute’s recently established Specimen Procurement Service Center was instrumental.
“Our team offers end-to-end services spanning specimen procurement, processing, histology and storage. Their involvement ensures we garner the highest quality of specimen collection,” she said.
Finally, the study expanded to include sample collection from known positive COVID-19 patients who were recovering at home with the assistance of the Champaign-Urbana Public Health District. In all, they worked to collect more nearly 500 patient samples.
“This is exactly the type of collaboration and innovation we envisioned when we launched the Carle Illinois College of Medicine. Our best, bright minds of today alongside our future physician innovators to creatively solve real-world healthcare problems,” Mark Johnson, MD, Critical Care and Carle Illinois faculty, said.
He, Karen White, MD, PhD, James Kumar, MD, and other Carle Illinois faculty advised on the study and worked to implement it through their patients.
While the recent Food and Drug Administration Emergency Use Authorization for the saliva-based testing is exciting, it’s availability for use in a healthcare setting still remains unknown.
“It’s indeed exciting progress. It has the potential to expand testing capacity in our community, the state and the nation showcases our region’s health and research partnerships and our ability to innovate,” Robert Healy, MD, chief Quality officer, said.
Carle Laboratory Services will closely monitor the ongoing FDA approval process to see if Carle can offer it in the future.
“As you can imagine, it’s not a simple yes or no on whether we can implement saliva-based testing at Carle,” Alastair Dunnett, director of Laboratory Services, said. “Because it’s still so new, there’s still much to learn about the accuracy and validity of this type of testing and whether Carle’s current equipment matches up.”
Unlike most coronavirus tests, which involve a nasal swab, the Illinois-developed saliva test, called I-COVID, asks those tested to provide a small saliva sample into a sterile test tube. The I-COVID test yields results in hours, even at high testing volumes.
Categories: Culture of Quality