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

脓毒症是一种鲜为人知的临床综合征，其特征是免疫系统失调。对感染的反应。它是导致死亡的主要原因，也是美国医院治疗费用最高的疾病，每年造成203亿美元的负担，占全国医疗保健系统总成本的5.2%。脓毒症具有高度的时间依赖性，每延迟1小时使用抗生素，不良预后的几率就会增加3-7%。目前迫切需要一种能够快速评估患者是否有败血症风险的工具。理想情况下，这种工具可以非常快速地收集任何相关信息，并在不到30分钟的时间内直接向医生提供败血症的可能性。如果这个工具是可用的，围绕早期败血症筛查的许多不确定性可以最小化。死亡率、再入院率、住院时间、ICU住院时间、住院费用以及对医疗保险和医疗补助服务中心核心措施的依从性等结果都可以通过该工具得到改善。SBIR一期项目的目标是建立一种护理点传感器的可行性，该传感器可以测量一滴血中的细胞和蛋白质，从而最终对败血症进行分层。在第二阶段，我们将继续与我们的制造合作伙伴一起设计、优化和测试一次性使用的墨盒和便携式读取器，用于同时测量少量血液中的细胞和蛋白质。目标是开发一种可扩展的技术平台，可以同时从同一滴血中测量白细胞总数，中性粒细胞上CD64表达和2种蛋白质（IL-6和PCT），并且还可以通过改变检测中使用的珠子类型来测量不同的蛋白质。目的是使医生和医疗保健提供者能够在护理点进行频繁的测量，并整合临床和生物学数据来预测败血症和器官功能障碍。该项目的结果将是一个功能齐全的阅读器和随附的一次性药盒，用于测量这些关键的败血症生物标志物。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.