Sensitive Measurement of Cardiac Troponin I at Point of Care: The Silicon BioDevi

护理点心肌肌钙蛋白 I 的灵敏测量：Silicon BioDevi

• 批准号: 8648513
• 负责人: Octavian Florescu
• 金额: $ 99.3万
• 依托单位: SILICON BIODEVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-15 至 2016-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8648513
• 关键词: Accident and Emergency department; Acute myocardial infarction; Adult; American; Bedside Testings; Biological Assay; Biological Markers; Blood Cells; Blood capillaries; Blood specimen; Calibration; Cardiac; Caring; Categories; Cause of Death; Characteristics; Chemistry; Chest Pain; Clinical; Coronary; Coronary Care Units; Correlation Studies; Decision Making; Deep Vein Thrombosis; Diagnosis; Diagnostic; Dose; Drug Formulations; Excipients; Health Personnel; Healthcare Systems; Heart failure; Hematocrit procedure; Hospitals; Hour; Human; Immunoassay; Laboratories; Measurable; Measurement; Measures; Medical center; Membrane; Methods; Modeling; Myocardial Infarction; One-Step dentin bonding system; Outcome; Output; Partner in relationship; Patients; Performance; Plasma; Point-of-Care Systems; Pregnancy Tests; Preparation; Production; Protocols documentation; Pulmonary Embolism; Reagent; Reporting; Research Activity; Risk; Sampling; Sepsis; Shapes; Silicon; Specific qualifier value; Speed; Stratification; Surface; Symptoms; System; Technology; Testing; Time; Troponin; Troponin I; United States Centers for Medicare and Medicaid Services; Validation; Western World; Whole Blood; Work; base; capillary; comparative; design; digital; magnetic beads; microchip; point of care; public health relevance; research study; response; standard of care

DESCRIPTION (provided by applicant): Acute myocardial infarction (MI), aka "heart attack" is the biggest killer in the western world and is the cause of death for nearly 500,000 Americans each year. The symptoms of MI can be vague and non-specific; for this reason 6 to 9 million adults present to hospital Emergency Departments in the US and are worked up for suspected MI annually. Advances in cardiac biomarkers have had a large impact on the diagnosis, risk stratification and management of suspected MI patients and rapid and sensitive testing of the cardiac biomarkers troponin has become the cornerstone for diagnostic workup and care of suspected MI patients. Rapid troponin testing can decrease time to appropriate treatment for MI patients and allow for faster MI rule-out, which will help decrease the $10 to $13 billion expended annually for the care of non-MI patients in coronary care units. Yet, despite the clear need for sensitive and rapid cardiac troponin measurements to quickly diagnose and manage patients, there is no POC system that can match the analytical performance of contemporary sensitive laboratory systems. In this project we will produce and demonstrate a fully integrated POC immunoassay platform, based on a CMOS microchip, that is as easy to use as an over the counter pregnancy test and as accurate as state-of- the-art laboratory tests (15pg/mL with 10% CV). In addition to troponin, which is critically important, the system is capable of measuring a myriad of other biomarkers for heart failure, pulmonary embolism and deep vein thrombosis, sepsis and other conditions where speed, convenience and in the field measurement of biomarkers is important.

描述(申请人提供)：急性心肌梗死(MI)，又名“心脏病发作”，是西方世界最大的杀手，也是每年近50万美国人的死因。心肌梗塞的症状可以是模糊的和非特定的；因此，每年有600到900万成年人到美国的医院急诊科接受疑似心肌梗塞的检查。心脏生物标记物的发展对疑似心肌梗死患者的诊断、风险分层和管理产生了重大影响，而对心脏生物标记物肌钙蛋白的快速和敏感检测已成为疑似心肌梗死患者诊断检查和护理的基石。快速肌钙蛋白检测可以缩短心肌梗死患者接受适当治疗的时间，并允许更快地排除心肌梗死，这将有助于减少每年在冠心病护理病房治疗非心肌梗死患者所花费的100至130亿美元。然而，尽管显然需要灵敏和快速的心肌肌钙蛋白测量来快速诊断和管理患者，但没有一种POC系统可以与当代灵敏的实验室系统的分析性能相媲美。在这个项目中，我们将生产和展示一个完全集成的POC免疫分析平台，该平台基于一个CMOS微芯片，既易于使用，又像柜台验孕一样容易使用，并与最先进的实验室测试一样准确(15pg/ml，10%CV)。除了肌钙蛋白这一至关重要的因素外，该系统还能够测量各种其他生物标记物，如心力衰竭、肺栓塞、深静脉血栓形成、败血症和其他需要快速、方便和现场测量生物标记物的情况。