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

该SBIR I期项目旨在开发一种用于更好地早期筛查脓毒症的设备。 脓毒症每年花费美国医疗保健系统超过240亿美元，每年有多达310万例病例夺去30多万人的生命。在美国，每两到三例医院死亡中就有一例是由于败血症。全世界估计有1900万例，一些报告估计每4秒就有1人死于败血症。严重脓毒症的死亡率在20%至50%之间。最紧迫的问题是缺乏准确的早期筛查方法。治疗每延迟一小时，存活率下降7.6%。目前败血症的筛查使用SIRS标准，包括体温、心率、呼吸频率和总WBC计数。这些参数对于脓毒症的早期筛查具有非常低的特异性。该项目将用一组细胞和蛋白质生物标志物取代这些参数，以提供高度特异性和敏感性的脓毒症检测和分层。将开发一种手持式床旁设备和一次性使用测试卡片，能够在单个测试卡片中的一滴血中提供总白色血细胞计数、淋巴细胞、粒细胞/单核细胞和CD 64中性粒细胞。在美国，这样的系统每年可以挽救数十万人的生命，节省数十亿美元的医疗费用。该项目将开发一种即时传感器，可以测量一滴血中的细胞计数和蛋白质。该技术结合了微流控、微加工和片上基于电的细胞和颗粒计数的能力，开发了一种革命性的新技术，将电库尔特计数与细胞和颗粒的免疫捕获相结合。开发的设备将是唯一一个能够在单个设备中提供血液分析仪，流式细胞仪，蛋白质和DNA检测的关键信息的设备。该项目使所有这些工具的力量能够从一个简单、强大和可扩展的平台中得到利用。这样的装置可以显著增加从患者群体中对生物标志物进行采样的频率和复用。在本提案中，商业级测试卡片将用于开发降钙素原（FDA批准的脓毒症生物标志物）的蛋白质测量，以及来自医院环境的健康和患病患者的血滴的细胞计数。

This SBIR Phase I project proposes to develop a device for better, early screening of sepsis. Sepsis costs the U.S. health care system over $24 billion every year, with as many as 3.1 million cases that claim over 300,000 lives annually. One out of every two to three hospitals deaths in the U.S. is due to sepsis. There are an estimated 19 million cases worldwide, and some reports have estimated that 1 person dies from sepsis every 4 seconds. Mortality rates due to severe sepsis are between 20% and 50%. The most urgent problem is a lack of accurate early screening methods. Survival rates drop by 7.6% per hour treatment is delayed. Current screening for sepsis utilizes the SIRS criteria, which include temperature, heart rate, respiratory rate, and total WBC count. These parameters have very low specificity for early screening of sepsis. This project will replace these parameters with a panel of cell and protein biomarkers to provide highly specific and sensitive detection and stratification for sepsis. A hand-held point-of-care device and a one-time-use cartridge capable of providing total white blood count, lymphocyte, granulocyte/monocyte, and CD64 Neutrophils all from one drop of blood in a single cartridge will be developed. Such a system could save hundreds of thousands of lives and billions of dollars in healthcare costs every year in the United States.This project will develop a point of care sensor that can measure cell counts and proteins from a drop of blood. The technology combines the power of microfluidics, microfabrication, and on-chip electrically based cell and particle counting to develop a revolutionary new technology that combines electrical coulter counting with immuno-capture of cells and particles. The developed device would be the only one with the capability to offer in a single device the critical information of hematology analyzers, flow cytometers, protein, and DNA assays. This project enables the power of all of these tools to be harnessed from a single inherently simple, powerful, and scalable, platform. Such a device could dramatically increase both the frequency and the multiplexing of sampling of biomarkers from patient populations. In this proposal, commercial grade cartridges will be used to develop protein measurements for procalcitonin, an FDA approved biomarker for sepsis, in addition to cell counting, from drop of blood of healthy and sick patients from hospital settings.