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

项目摘要 急性心肌梗死(MI)是西方世界最大的杀手，也是导致 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 每年在美国医院急诊科就诊的特定患者和700万成年人 疑似心肌梗塞。心脏生物标志物的进展对诊断产生了很大影响， 疑似心肌梗塞患者的风险分层和管理以及快速和敏感的检测 心脏生物标志物，特别是肌钙蛋白，已经成为诊断检查的基石 以及对疑似心肌梗塞患者的护理。快速肌钙蛋白检测可以将时间缩短到适当的时间 治疗心肌梗死患者，并允许更快地排除心肌梗死，这将有助于减少数十亿 每年用于冠心病护理病房中非心肌梗死患者的护理。然而，尽管有明确的 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，没有一种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，使用起来像 一种非处方怀孕测试，与高灵敏度的实验室测试一样准确。在……里面 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、脓毒症和 生物标志物的速度、方便性和现场测量的其他条件 很重要。

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.