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 临床传感器公司开发了一种可制造的原型微流体传感器，用于测量一氧化氮， 全血这个STTR第二阶段项目旨在完成商业化所需的几个关键目标， 器械，包括在败血症中临床评价NO水平的临床研究。脓毒症是导致 非心脏重症监护病房（ICU）的死亡原因。每年，败血症影响160万人， 25万人死亡医疗费用超过200亿美元。脓毒症的发病率和费用负担是稳定的 增加。广义上，脓毒症被理解为响应全身性炎症的病理生理状态。 血液中细菌和/或真菌病原体感染。脓毒症的定义是不断发展的新的 出现了关于这种疾病的研究，临床医生寻求更好地管理患者护理。然而，治疗 范例保持一致：及时检测和采取行动对于降低脓毒症相关发病率至关重要 和死亡率以及降低与脓毒症护理相关的费用。目前，脓毒症及其相关的 综合征“缺乏特定的临床、影像学、实验室或生化标志物来证实其 存在感“一氧化氮（NO）是宿主对感染应答过程中内源性产生的一种病原体 在败血症诱导的器官功能障碍中，并已被提议作为败血症的潜在生物标志物。直到最近， 还没有直接测量复杂基质如血液中NO的工具。我们开发了一种先进的 类微流体传感器，能够测量全血中的NO。有了这个工具， 表明在败血症的临床前模型中NO水平迅速增加。在第一阶段，我们开发了一个 原型传感器，展示了其在血液中前所未有的分析性能，并证实了其能力 以监测临床前模型中的病理生理NO水平。在第二阶段，我们组建了一个团队， 科学家，工程师和临床研究人员完成关键路径上的关键步骤， 试验用器械豁免（IDE），并最终将该器械商业化。