SBIR Phase II: Point of Care Device for High Frequency Stratification of Patient Populations at Risk of Sepsis

Sepsis is a poorly understood clinical syndrome and is characterized by a dysregulation of the immune system?s response to infection. It is the leading cause of death and is the most expensive condition treated in U.S. hospitals, exerting a $20.3 billion burden annually, 5.2% of total costs to the healthcare system nationwide. Sepsis is highly time critical and every 1-hour delay in antibiotics is associated with a 3-7% increase in the odds of a poor outcome. There is currently a dire need for a tool that can quickly assess if a patient is at risk for sepsis. Such a tool would ideally gather any relevant information very quickly and provide a probability of sepsis directly back to the physician in less than 30 minutes. If this tool were available, a lot of the uncertainty revolving around early sepsis screening could be minimized. Outcomes such as mortality, readmission rate, length of stay, length of ICU stay, hospital cost, and compliance to Center for Medicare and Medicaid Services Core Measures could all be improved by such a tool. The goal of the SBIR Phase I project was to establish the feasibility of a point of care sensor that can measure cells and proteins from a drop of blood for the eventual stratification of sepsis. In Phase II, work will continue with our manufacturing partners to design, optimize, and test a one-time-use cartridge and a portable reader for the simultaneous measurement of cells and proteins from a small volume of blood. The objective will be to develop a scalable technology platform, that can measure total white blood cell count, CD64 expression on neutrophils, and 2 proteins (IL-6, and PCT), simultaneously from the same drop of blood, and also be able to measure different proteins by changing the types of beads used in the assay. The goal is to allow physicians and healthcare providers to perform frequent measurements at the point of care, and to integrate the clinical and biological data to predict sepsis and organ dysfunction. The result of this project will be a fully functional reader and accompanying disposable cartridges for the measurement of these critical sepsis biomarkers. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.