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）是西方世界最大的杀手，每年是近50万美国人的死因。MI的症状可能是模糊和非特异性的;因此，每年有600万至900万成年人到美国医院急诊室就诊，并因疑似MI而接受检查。心脏生物标志物的进展对疑似MI患者的诊断、风险分层和管理产生了很大影响，心脏生物标志物（特别是肌钙蛋白）的快速灵敏检测已成为疑似MI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用于冠心病监护病房非心肌梗死患者护理的100亿至130亿美元。然而，尽管明确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POC系统可以匹配当代灵敏实验室系统的分析性能。此外，急诊科对速度的需求将变得更加重要，因为CMS指标将于2013年实施，该指标规定必须在患者就诊后1小时内提供心肌肌钙蛋白结果。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CMOS微芯片，与非处方妊娠测试一样易于使用，与最先进的实验室测试一样准确（15 pg/mL，CV为10%）。除了肌钙蛋白，这是至关重要的，该系统将能够测量无数的其他生物标志物的心脏衰竭，肺栓塞和深静脉血栓形成，败血症和其他条件下，速度，方便和现场测量的生物标志物是重要的。 公共卫生相关性：缺乏实验室质量的床旁（POC）测试迫使供应商实施低效的测试协议或根据不完整的信息做出决策。这影响了结果，并导致整个医疗保健系统每年花费数十亿美元用于不必要的治疗。在这个项目中，我们展示了一个基于微芯片的检测平台，该平台可以进行实验室精度和一步协议的检测，并且可以使用现有的铸造能力进行大规模生产。

DESCRIPTION (provided by applicant): 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; 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 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 $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. Further, the need for speed will become even more important for emergency department as a CMS indicator will be implemented in 2013 which specifies that cardiac troponin results must be available within 1 hour of patient presentation. 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 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. PUBLIC HEALTH RELEVANCE: The lack of laboratory quality point-of-care (POC) tests forces providers to implement inefficient testing protocols or make decisions based on incomplete information. This effects outcomes and causes the healthcare system as a whole to spend billions of dollars each year on unnecessary treatments. In this project we demonstrate a microchip-based assay platform that performs assays with laboratory precision and a one-step protocol and which can be mass- produced using existing foundry capacity.