A Rapid Saliva Antigen Test for SARs-CoV-2 Detection

The pandemic caused by COVID-19 has been associated with a very high disease burden as well as high global financial costs. With this pandemic came massive shut downs of both private and public businesses including schools, retail stores, and restaurants. In order to be able to safely open these places of business and have millions of workers return to work and children return to school safely, there is a dire need for a rapid, simple, and inexpensive test which can be administered in non-clinical settings including businesses, schools, and even at home. There are over 600 tests currently being developed, including potentially promising tests using saliva samples and nasopharyngeal swabs. However, these tests have several disadvantages including requirement of instruments, discomfort with nasopharyngeal swabs, and/or long processing times. A simple, low-cost, rapid saliva-based test was developed using test strips that incorporate novel high affinity SARS-CoV-2 binder nanodiscs. The aims of this study were focused on producing and optimizing the test strip components and performing a feasibility study on archived patient samples. By completing these goals, test strips that have the capability of use in office settings, schools, sports events, and potentially at home were produced. To achieve these goals, a partnership was established between bioActive Labs LLC, led by Dr. Jeff Hall who has more than 25 years of experience in design and development of medical diagnostics, and this study's lab, which has engineered the new binder proteins and developed the SARS-CoV-2 assays.