New Saliva-Based COVID-19 Test is Less Invasive, More Accessible and Delivers Accurate Results at Lower Cost

The team is also working with Thermo Fisher Scientific Inc. (Waltham, MA, USA) to validate the test and provide the necessary supply chain for distribution.

The test uses branched DNA assay technology as against the more common polymerase chain reaction (PCR) tests which receive high marks for their sensitivity, but also require extraction of the nucleic acids, access to thermocyclers and other sophisticated lab equipment not as readily available across the world. With the Rhode Island Department of Health, the team has validated the assay using standard reference materials and specimens. Based on trials conducted thus far, 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 University is now 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 US Food and Drug Administration. The trial will screen student-athletes and others who consent to take part, with the data collected to be included as part of the University’s application to the FDA. 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. The researchers believe that the COVID-19 test will be one of the few assay tests that could be made globally available.

“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,” said URI Professor of Biomedical and Pharmaceutical Sciences Angela Slitt who led the team.

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University of Rhode Island
Thermo Fisher Scientific Inc.