KINGSTON, R.I. — A new saliva test for COVID-19 created by University of Rhode Island researchers could soon be in use across the school’s campuses — and later worldwide, if it gets federal approval.
The development comes as university officials have expressed concern about a recent rise in COVID cases at URI.
The university is launching a clinical trial this week as part of the final phase of data collection and validation in preparation for an Emergency Use Authorization submission to the U.S. Food and Drug Administration, URI said.
FDA approval of the test for diagnostic purposes would have far-reaching implications, both at home and abroad, in terms of increasing accessibility to testing to help manage pandemic response.
In Rhode Island, FDA approval of the test would mean it could be made widely available on URI’s campuses and at local colleges, universities and schools across the state, along with the common nasal swab tests.
On Tuesday, the university’s COVID-19 tracker showed a 1.8% positive COVID-19 test rate over the past seven days, down from more than 2.5% in early February. URI tested 5,027 people from March 9-15 and found 88 unique positive cases.
Since Jan. 1, the university has administered 57,089 COVID tests and had 999 positive cases.
A team at URI led by Professor of Biomedical and Pharmaceutical Sciences Angela Slitt started work on the new test last spring.
“One of the things we set out to do was to develop a less invasive, more cost-effective, more accessible test,” Slitt said. “And I think we’ve done that. We use saliva, work off different supply chains, use different, less cost-prohibitive instrumentation and are effectively lowering the barriers to entry for many.”
Work started at a point when access to the more common polymerase chain reaction (PCR) tests was severely hampered by disruptions in the supply chain. Although PCR-based tests get high marks for their sensitivity, they also require extraction of nucleic acids and access to sophisticated lab equipment not as readily available outside of the United States.
Slitt’s research was already part of URI’s Sources, Transport, Exposure, and Effects of PFASs (STEEP) lab, funded by the National Institutes of Health Superfund Research program, to look at changes in genetic material when the idea hit her. Her PFAS test is used to look at these changes using what’s called branched DNA assay technology that is more commonly available in labs throughout the United States.
Slitt reasoned that the research could be adapted to identify coronavirus in human saliva samples.
Now in the final stretch of data collection to apply for Emergency Use Authorization through the FDA, Slitt believes the team’s COVID-19 test will be one of the few assay tests that could be made available globally.
“With minimal scientific equipment, we can not only increase our capacity in the United States, but also help to put tools into the hands of people in developing countries that they can use,” she said.
Based on completed trials, the test appears to have a high level of sensitivity similar to, or more sensitive than, other top-performing saliva tests on the market — meaning the test is better able to comparably detect the level of viral load in the sample. This is particularly helpful in gauging infectivity and possibility for spread.
The team is also working with Thermo Fisher Scientific of Waltham, Massachusetts to validate the test and provide the necessary supply chain for distribution.
The trial, launching this week, was conducted in cooperation with URI Athletics and URI Health Services. It will screen student-athletes and others who agree to take part. The collected data will be included as part of the university’s application to the FDA. URI also set up a lab at the Kingston campus expressly to test results from the trial.
The effort is a partnership between URI’s College of Pharmacy and the URI Research Foundation, with financial support from the office of URI President David M. Dooley.
“From start to finish this has been an extraordinary team effort, drawing on expertise and support from across the university, as well as from the Rhode Island Department of Health and experts in industry, to protect our students and make a positive impact for others,” Dooley said. “The development of the test and the lab really speak to our mission as a research university engaged in relevant work that affects people’s lives.”