Development of a Wide Multiplexing, Multifunctional Platform for Flexible Diagnostics

Critical medical care requires comprehensive measurement of multiple biomarkers to improve diagnosis, staging, treatment, and monitoring. Multifunctional and multiplexing capabilities allow for the simultaneous measurement of multiple biomarkers while combining multiple assay formats, enhancing diagnostic efficiency and reliability, and supporting personalized medicine. These capabilities also simplify workflows, save time, lower costs, and reduce equipment load. However, most commercial multiplexing systems are designed for centralized laboratories, and while some point-of-care instruments with Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver (COW) exist, none have multifunctional capabilities. In military settings, specifically, diagnostic needs vary by care level. Role 1 and Role 2 facilities, which provide initial triage and treatment near the battlefield, have limited diagnostic technology and resources, and could greatly benefit from a multiplexed and multifunctional diagnostic platform.   During this 6-month Phase I proposal, Baebies will utilize our core digital microfluidic technology to provide a comprehensive point-of-care diagnostic platform that can be used in military and civilian settings. Our proposal focuses specifically on developing a novel test cartridge that supports fast, wide multiplexing and automated sample preparation of whole blood. We will develop a sample-to-answer 25-plex RT-qPCR test and an immunoassay to be performed on the same test cartridge to establish feasibility. The automated sample preparation protocol will be completed within 15 minutes to reduce overall time-to-result of future tests. Analytical performance of the sample-to-answer assays will also be evaluated via reliability and reproducibility studies. We anticipate developing diagnostic tests for trauma and military-related diseases (sepsis, traumatic brain injury, etc.) on our prototype system through future efforts and will strive to optimize these tests to achieve the necessary sensitivity, specificity, and rapid results required for CLIA COW status. Development of a wide multiplexing, multifunctional diagnostic platform with CLIA-waiver is essential to provide access and improve critical medical care in distributed settings.