Convenient, rapid and affordable COVID-19 testing technology is getting a widespread community try-out through the COVID-19 Test Us program, part of the National Institutes of Health Rapid Acceleration of Diagnostics initiative, or RADx initiative. Underway since spring 2020, RADx has expanded innovation and increased availability of tests, while ensuring the reach of testing to underserved populations.
Several times a week, UMass Medical School researchers offer Worcester-area residents the opportunity to enroll in some of the half-dozen or so studies conducted for COVID-19 Test Us.
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.
On Aug. 5, study coordinators, nurses and physicians were at Mercantile Center in downtown Worcester to enroll participants in studies from among the public who came for UMass Memorial Health’s free COVID-19 testing. One such study was to assess the benefits of self-administered testing using Quidel Corp.’s QuickVue At-Home COVID-19 test, which received Food and Drug Administration authorization on March 31 for home use without a prescription.
Participants test themselves daily with the at-home kit, using a phone app, and submit periodic samples for laboratory-based PCR analysis by Quest Diagnostics to compare results, according to clinical research coordinator Janvi Nanavati.
“At-home testing and rapid testing has really been the thing that’s been the goal for all of us since the pandemic really began,” said Nathaniel Hafer, PhD, assistant professor of molecular medicine and lead investigator of RADx Tech Study Logistics Core.
Dr. Hafer said RADx Test Us has enrolled more than 2,200 people in approximately 12 studies across the United States.
Along with UMass Medical School, COVID-19 Test Us program research partners include Johns Hopkins University, Northwestern University, UMass Lowell, University of Kansas, University of Iowa, Oregon Health Sciences University and Morehouse School of Medicine.
Last fall and winter, researchers typically enrolled 30 to 50 people in testing studies during each four-hour testing and enrollment event. Once COVID-19 vaccines became widely administered over the spring, interest in testing studies waned to enrolling five to 12 people during a session, according to Hafer.
“In the last week or two, we’ve seen an uptick,” Hafer said, attributing increased interest to concern about the highly contagious Delta variant.
“Testing is the number one way to know whether or not you’re infected,” said Nanavati. “People who have this awareness obviously aren’t going to socialize as much; they’re going to isolate. And frequent testing is really the only way to know if you’re positive or not, especially with the rise in asymptomatic cases, and especially with cases in unvaccinated and vaccinated individuals.”
Nanavati said researchers were hoping to enroll unvaccinated individuals who have been exposed to somebody with COVID-19 in the past seven days, but who are asymptomatic. Participants also need to be able to download the app on their phone and should not have had COVID before.
But other studies may have different enrollment criteria. “Studies are open to all comers, for the most part,” Hafer said, even those who have been vaccinated. “As we’ve seen, some breakthrough cases have become more common.”
Clinical research coordinator Kelsey Woods stood outside the testing site at Mercantile Center, recruiting people who came for COVID tests to participate in a RADx study.
The study she offered for enrollment on this day is only for unvaccinated candidates. She said she’s seen “a good amount of interest, but the problem is most people are vaccinated, which makes it a little bit difficult for this study.”
“I think people that come across these studies are really excited and willing to participate just because the COVID-19 pandemic has affected everybody,” said Nanavati. “I think it makes them feel productive and like they can help in some positive way to get us over the pandemic.”
The UMass Medical School RADx Test Us team attends “Stop the Spread” COVID-19 test events at Mercantile Center, 100 Front St., every Monday and Thursday, from 11 a.m. to 3 p.m.
The RADx initiative partners with federal agencies, including the Office of the Assistant Secretary of Health, Department of Defense, the Biomedical Advanced Research and Development Authority, Centers for Disease Control and Prevention, and the Food and Drug Administration.