The non-invasive saliva test increases reach, is accurate, simple, and cost-effective
Kingston, Rey – March 16, 2021 – Researchers at the University of Rhode Island have developed a new COVID-19 test that will soon be used across its campus as a screening and monitoring tool for the COVID-19 virus. The saliva-based test is less invasive than many of the traditional nasal swab tests used, and researchers say it is sensitive, specific, and can provide results at a lower cost. The university is launching a clinical trial this week as part of its final data collection and validation phase in preparation for submitting an emergency use permit to the FDA.
Led by URI professor of biomedical and pharmaceutical sciences Angela Slate, the team began work on the test, which uses branched-branched DNA screening technology, last spring when access to the most common polymerase chain reaction (PCR) tests was severely hampered by disruptions at suppliers. Although the PCR-based tests obtain high scores for their sensitivity, they also require extraction of nucleic acids, access to thermal cycling equipment and other sophisticated laboratory equipment not readily available outside of the United States.
“One of the things we set out to do was to develop a test that was less invasive, more cost-effective, and more accessible,” said Slate. And I think we did. We are using saliva, we are shutting down different supply chains, we are using different, less expensive tools, and we are working effectively to reduce the barriers to entry for many. “
Slitt was already using her research in the Sources, Transfer, Exposure, and Effects of PFASs (STEEP) lab at URI, funded by the National Institutes of Health Superfund Research Program, to look at changes in the genetic material when the idea came up. Because her PFAS test is finally being used to look at these changes using the branching DNA assay technology that is more commonly available in laboratories across the United States, she has seen that this research can be adapted to identify coronavirus in human saliva samples.
With the Rhode Island Department of Health, the team validated the assay using standard reference materials and samples. The team is also working with Thermo Fisher Scientific, from Waltham, Massachusetts, to validate testing and provide the supply chain needed for distribution.
Now in the final stage of collecting data to apply for an emergency use license through the Food and Drug Administration, Slitt believes the team’s COVID-19 test will be one of the few screening tests that could be made available globally. Based on the experiments conducted so far, the test appears to have a similar or more sensitive high level of sensitivity than other high-performing saliva tests on the market – meaning that the test is better able to better detect the level of viral load in the sample. This is especially useful in measuring infection and potential spread.
The trial, which began this week, in collaboration with URI Athletics and URI Health Services, will examine student athletes and others who agree to participate, with data collected to be included as part of the university’s application to the Food and Drug Administration. The university set up a laboratory on the Kingston campus specifically for the trial. This effort is a partnership between the URI College of Pharmacy and the URI Research Foundation, with financial support from the URI President’s Office.
“From start to finish, this was an exceptional team effort drawing on experience and support from across the university, as well as from the Rhode Island Department of Health and industry experts, to protect our students and make a positive impact for others,” said URI President David M. international. “Test and lab development really speaks to our mission as a research university involved in related work that impacts people’s lives.”
The Food and Drug Administration’s approval of testing for diagnostic purposes will have far-reaching implications, both at home and abroad, in terms of increasing access to testing to help manage the pandemic response. In Rhode Island, FDA approval of the test means it can be made widely available for monitoring and risk assessment at URI campuses and local colleges and universities, as well as for schools across the state to help monitor and test for coronavirus. . Outside the United States it can have a profound impact.
“With minimal scientific equipment, we can not only increase our capacity in the United States but also help put tools in the hands of people in developing countries that can use them,” says Slate.
URI Research oversees the commercialization of protected intellectual property, developing business relationships with companies and government partners for the University of Rhode Island as part of its mission to assist URI faculty, staff, and students whose research often leads to new companies, cutting-edge patents, and innovative public-private partnerships .