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

描述（由申请人提供）：急性心肌梗死（MI），又名“心脏病发作”，是西方世界最大的杀手，每年导致近50万美国人死亡。心肌梗死的症状可以是模糊和非特异性的；因此，美国每年有600万至900万成年人到医院急诊室就诊，并因疑似心梗而接受检查。心脏生物标志物的进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，快速、灵敏地检测心肌生物标志物肌钙蛋白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对心肌梗死患者进行适当治疗的时间，并允许更快地排除心肌梗死，这将有助于减少每年在冠状动脉护理单位用于治疗非心肌梗死患者的100亿至130亿美元。然而，尽管明确需要敏感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POC系统可以与当代敏感实验室系统的分析性能相匹配。在这个项目中，我们将生产和演示一个完全集成的POC免疫分析平台，基于CMOS微芯片，它像非处方妊娠试验一样容易使用，像最先进的实验室测试一样准确（15pg/mL, 10% CV）。除了至关重要的肌钙蛋白外，该系统还能够测量心力衰竭、肺栓塞和深静脉血栓形成、败血症和其他条件下的无数其他生物标志物，在这些条件下，生物标志物的速度、便利性和现场测量很重要。

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.