LOWELL, Mass. – UMass Lowell researchers and students will help evaluate the effectiveness of new, rapid methods to diagnose COVID-19 through a program overseen by the National Institutes of Health.
The NIH awarded $935,000 to UMass Lowell’s Solomont School of Nursing
for the project as part of the federal agency’s Rapid Acceleration of Diagnostics (RADx) initiative, created last year to help private industry develop affordable and accurate COVID-19 screening tests that can be administered and analyzed within minutes at home and at doctors’ offices, clinics, pharmacies, hospitals and community testing sites.
At UMass Lowell, nursing faculty and students will oversee RADx clinical trials that assess the viability of new products to help diagnose COVID-19 that are being developed by established and startup medical device and biotech companies. Products to be evaluated could be anything from more comfortable nasal swabs to the machines that analyze samples. The initiative will also involve community partners that can offer COVID-19 testing sites for the study.
The project will be led by UMass Lowell Nursing Assoc. Prof. Ainat Koren, along with Nursing Chair and Assoc. Prof. Heidi Fantasia, Assoc. Prof. Comfort Enah and Clinical Asst. Prof. Lisa Marchand.
“Nursing is at the forefront of the pandemic. Being an active participant in assisting with the development of accurate point-of-care devices is one of our roles as educators and leaders in the profession,” Koren said.
RADx draws upon the expertise of five academic centers across the country, including the Center for Advancing Point of Care Technologies (CAPCaT
), a partnership between UMass Lowell and UMass Medical School that is a product of the institutions’ joint venture, the Massachusetts Medical Device Development Center (M2D2
CAPCaT is led by UMass Lowell Prof. Bryan Buchholz, chair of the Biomedical Engineering Department, and Dr. David McManus, chair of the Department of Medicine at UMass Medical School, where he is the founding director of the Program in Digital Medicine. Koren serves on the CAPCaT review team and on the executive board of M2D2.
PCR laboratory tests are the gold standard for detecting the SARS-CoV-2 virus, according to the U.S. Centers for Disease Control and Prevention. However, results from this type of test are often not returned quickly. Fast-acting tests to diagnose COVID-19 are currently available under emergency use authorization from the U.S. Food and Drug Administration. Test developers have manufactured rapid PCR and rapid antigen test platforms, some with excellent sensitivity. For example, some rapid PCR tests have greater than 95 percent positive agreement with the gold standard PCR lab test and some new rapid antigen tests have achieved greater than 91 percent positive agreement, with improved results when the test is repeated.
Companies with emerging technologies selected for the clinical trials completed a rigorous review process, according to Koren.
“The focus is to assist the scientists to check their devices in the field and compare the results to current testing methods, so that they can see the sensitivity and reliability of the device as well as its usability,” she said. “In addition, samples will be collected to form a test bank of positive and negative COVID-19 samples for future research.”
The trials will be conducted in partnership with a medical group that offers drive-through testing, UMass Lowell’s own testing clinic and possibly mass testing events. Koren also hopes to partner with a local hospital as well.
At each site, nurses and nursing students will ask patients who come in for a COVID-19 screening if they are willing to take another test with an experimental device to aid in the research. Patients who consent will then answer a few questions and get the second test. Results from the tests using the experimental devices or methods will be compared to results on the same samples using the established gold standard devices or methods.
UMass Lowell nursing student Caroline Owusu, a Worcester resident who has worked on other research projects with Koren, is excited to help with the clinical trials and to gain more research insights.
“I’m just looking forward to getting hands-on experience as a nurse,” Owusu said. “This research is very important in helping us keep up the pace in transitioning to a more normal world.”
This project is made possible with federal funding from the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, via grant 3 U54 HL143541-02S2.
About the RADx Tech Clinical Studies Core
A team led by David McManus, MD, the Richard M. Haidack Professor in Medicine and chair and professor of medicine, and Laura Gibson, MD, associate professor of medicine, was awarded $123 million in 2020 to oversee the clinical studies component of point-of-care and home-based diagnostics. The Clinical Studies Core has partner institutions across the country and is an arm of RADx Tech, the component of RADx that speeds development and production of innovative COVID-19 diagnostic technologies.
About UMass Lowell
UMass Lowell is a national research university offering its more than 18,000 students bachelor’s, master’s and doctoral degrees in business, education, engineering, fine arts, health, humanities, sciences and social sciences. UMass Lowell delivers high-quality educational programs and personal attention from leading faculty and staff, all of which prepare graduates to be leaders in their communities and around the globe. www.uml.edu