Highly sensitive measurement of cTnI without a reader: the Xip solution

无需读数仪即可高灵敏度测量 cTnI：Xip 解决方案

• 批准号: 9302002
• 负责人: Rajinder Bhatia
• 金额: $ 124.74万
• 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 2020-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9302002
• 关键词: Accident and Emergency department; Acute myocardial infarction; Adoption; Adult; Affect; Aging; Ambulances; American; Award; Bedside Testings; Biological Assay; Biological Markers; Blood; Calibration; Cardiac; Caring; Cause of Death; Characteristics; Chest Pain; Clinic; Clinical; Clinical Research; Coronary; Coronary Care Units; Data; Decision Making; Deep Vein Thrombosis; Devices; Diagnosis; Diagnostic; Drops; Evaluation; Fingers; Goals; Heart failure; Home environment; Hospitals; Hour; Housing; Human; Immunoassay; Investigation; Laboratories; Laboratory Sensitivity; Liquid substance; Measurement; Measures; Medical center; Modality; Multi-Institutional Clinical Trial; Myocardial Infarction; Nurses; One-Step dentin bonding system; Outcome; Patient risk; Patients; Performance; Phase; Plasticizers; Point-of-Care Systems; Pregnancy Tests; Process; Product Labeling; Production; Protocols documentation; Provider; Pulmonary Embolism; Reader; Research Activity; Risk Management; Risk stratification; Sampling; Secure; Sepsis; Silicon; Small Business Innovation Research Grant; Specific qualifier value; Speed; Standardization; Symptoms; System; Technology; Temperature; Testing; Time; Triage; Troponin; United States Centers for Medicare and Medicaid Services; Validation; Variant; Western World; Work; attack victim; base; design; digital; high risk; improved; microchip; nano; point of care; pre-clinical; standard of care; thermal stress; urgent care

Project Summary Acute myocardial infarction (MI) 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 and 7 million adults present to hospital Emergency Departments in the US each year with suspected MI. 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 cardiac biomarkers, specifically 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 billions 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. This project is intended to develop and commercialize 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 high sensitivity laboratory tests. In addition to troponin, which is critically important, the system will be able to measure 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.

项目摘要 急性心肌梗死（MI）是西方世界最大的杀手，是导致 每年有近50万美国人死亡。心肌梗死的症状可以是模糊的和非- 美国每年有700万成年人到医院急诊室就诊， 疑似心肌梗塞心脏生物标志物的进展对诊断产生了很大的影响， 疑似心肌梗死患者的风险分层和管理，以及快速和敏感的 心脏生物标志物，特别是肌钙蛋白，已成为诊断检查的基石 对疑似心肌梗死患者的护理。快速肌钙蛋白检测可以缩短适当的时间 治疗MI患者，并允许更快的MI排除，这将有助于减少数十亿美元的 每年花费在冠心病监护病房的非心肌梗死患者的护理上。然而，尽管明确 需要灵敏和快速的心肌肌钙蛋白测量，以快速诊断和管理 对于患者来说，没有任何POC系统可以与当代的分析性能相匹配 敏感的实验室系统该项目旨在开发和商业化一个完整的 基于CMOS微芯片的集成POC免疫分析平台， 一种非处方妊娠测试，与高灵敏度实验室测试一样准确。在 除了肌钙蛋白，这是至关重要的，该系统将能够测量无数的 心力衰竭、肺栓塞和深静脉血栓形成、败血症和其他生物标志物 在其他条件下，生物标志物的快速、方便和现场测量是必要的。 重要.