Microfluidic Nitric Oxide Sensor

微流控一氧化氮传感器

• 批准号: 9347968
• 负责人: Bruce A Cairns
• 金额: $ 72.37万
• 依托单位: CLINICAL SENSORS, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-01 至 2019-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9347968
• 关键词: Affect; Authorization documentation; Bacterial Infections; Benchmarking; Biochemical Markers; Biological Markers; Blood; Calibration; Caring; Cause of Death; Cessation of life; Chemicals; Clinic; Clinical; Clinical Markers; Clinical Research; Complex; Critical Illness; Critical Pathways; Detection; Devices; Diagnosis; Diagnostic; Disease; Engineering; Ensure; Functional disorder; Generations; Health Care Costs; Immune response; In Situ; In Vitro; Incidence; Infection; Intensive Care Units; Investigation; Laboratory Markers; Measurement; Measures; Methods; Microfluidics; Monitor; Morbidity - disease rate; Nitric Oxide; Organ; Pathologic; Patient Care; Patients; Performance; Phase; Population; Positioning Attribute; Pre-Clinical Model; Preparation; Production; Protocols documentation; Qualifying; Research; Research Personnel; Route; Sampling; Scientist; Sepsis; Site; Small Business Technology Transfer Research; Syndrome; System; Systemic infection; Techniques; Testing; Whole Blood; base; clinical Diagnosis; cost; imaging biomarker; improved; manufacturing process; mortality; pathogen; patient population; phase 2 study; potential biomarker; prototype; response; sensor; septic; success; tool

PROJECT SUMMARY Clinical Sensors has developed a manufacturable prototype microfluidic sensor for measuring nitric oxide in whole blood. This STTR Phase II project aims to complete several key aims necessary to commercialize this device, including a clinical study where NO levels will be evaluated clinically in sepsis. Sepsis is the leading cause of death in non-cardiac intensive care units (ICUs). Each year, sepsis affects 1.6 million people, causing 250,000 deaths and healthcare costs over $20 billion. The incidence and cost burden of sepsis are steadily increasing. Broadly defined, sepsis has been understood as a pathophysiological state in response to systemic infection by bacterial and/or fungal pathogens in blood. The definition of sepsis is continually evolving as new research emerges about this disease and clinicians seek to better manage patient care. However, the treatment paradigm remains consistent: prompt detection and action are critical for reducing sepsis-associated morbidity and mortality and reducing the costs associated with sepsis care. Currently, sepsis and its associated syndromes “lack specific clinical, imaging, laboratory, or biochemical markers with which to confirm their presence.” Nitric oxide (NO) is endogenously produced in the host response to infection, is a causative agent in sepsis-induced organ dysfunction, and has been proposed as a potential biomarker for sepsis. Until recently, no tools have existed to measure NO directly in complex matrices such as blood. We have developed a first-in- class microfluidic sensor that enables measurement of NO in whole blood. With this tool, we have demonstrated that NO levels increase rapidly in preclinical models of sepsis. In Phase I, we developed a prototype sensor, demonstrated its unprecedented analytical performance in blood, and confirmed its ability to monitor pathophysiologic NO levels in a pre-clinical model. For Phase II, we have assembled a team of scientists, engineers, and clinical researchers to complete key steps on the critical path to receiving an Investigational Device Exemption (IDE) and ultimately commercialize this device.

项目摘要 临床传感器已经开发了一种制造的原型微流体传感器，用于测量一氧化氮 全血。这个STTR II期项目旨在完成商业化所需的几个关键目标 设备，包括一项临床研究，该研究将在败血症中无法临床评估水平。败血症是领导者 非心脏重症监护病房（ICU）的死亡原因。每年，败血症会影响160万人，导致 250,000人死亡和医疗保健费用超过200亿美元。败血症的事件和成本燃烧稳定 增加。广泛定义的败血症已被理解为一种病理生理状态，以响应全身性 血液中细菌和/或真菌病原体感染。败血症的定义是不断发展的 有关这种疾病的研究，临床医生试图更好地管理患者护理。但是，治疗 范式保持一致：及时检测和动作对于降低败血症相关的发病率至关重要 以及死亡率并降低与脓毒症护理相关的成本。目前，败血症及其相关 综合征“缺乏特定的临床，成像，实验室或生化标志物来确认其 存在。“一氧化氮（NO）是在宿主对感染反应中的内源产生的，是一种灾难性的剂 在败血症诱导的器官功能障碍中，已被提议作为败血症的潜在生物标志物。直到最近， 在复杂物质（如血液）中，没有任何工具无法直接测量。我们已经开发了第一个 类微流体传感器，可以测量全血的NO。使用此工具，我们有 证明败血症的临床前模型中没有水平迅速增加。在第一阶段，我们开发了 原型传感器显示了其血液中空前的分析性能，并确认了其能力 监测临床前模型中的病理生理无水平。对于第二阶段，我们组建了一个团队 科学家，工程师和临床研究人员完成接收关键途径的关键步骤 调查设备豁免（IDE），并最终将此设备商业化。