Rapid Quantitative Point-of-Care Cardiac Marker Test

描述（由申请人提供）：提出了一种便携式，快速和定量的护理点（POC）系统，用于评估潜在的急性冠脉综合征（ACS）患者。该系统将用于通过测量多种心脏标志物（CM）浓度来快速分诊胸痛患者。该系统将用于急诊科、医生办公室和救护车，以快速识别ACS患者，并将减少不必要的住院，降低医院成本，并防止意外释放ACS患者。该系统将改进目前可用的POC CM测试，通过使用便携式仪器格式提供快速和经济的方法来量化多个CM。这将大大提高CM检测的效率，允许在救护车、医生办公室和患者家中进行CM测量，并方便在医院急诊科进行床边检测。该系统包括两部分，一次性电化学测定条和用于读取和定量测定的手持式装置。所提出工作的关键创新是应用快速方便的流动分析格式，结合电化学生物传感器，允许敏感的多分析物定量。第一阶段的具体目标是制造概念验证的电化学免疫测定方法，并演示其在同时定量血清样品中的两种重要CMs（肌红蛋白和肌钙蛋白I）中的使用。第一阶段的项目将展示我们系统的可行性，提供概念验证电化学分析，这将在第二阶段发展成包含传感电极的高密度分析条，用于更大范围的CMs，以及原型电化学分析读取器的开发。快速、便携、定量和经济的POC检测将成为诊断ACS患者的宝贵工具。CM POC测试预计在未来几年内每年增长20%以上，2006年的销售额将超过1.6亿美元。这是为我们的技术创造一个利基市场的绝佳机会，它比当前的POC测试具有优势。EIC通过内部制造，销售电化学分析和手持式分析阅读器，以及对外许可我们的多分析物免疫分析技术，为分析技术提供了明确的商业途径。

DESCRIPTION (provided by applicant): The development of a portable, rapid and quantitative point-of-care (POC) system for the evaluation of patients with potential acute coronary syndromes (ACS) is proposed. The system will be used to rapidly triage patients with chest pains by measuring multiple cardiac marker (CM) concentrations. The system will have use in emergency departments, doctors' offices and ambulances for the rapid identification of patients with ACS, and will reduce unnecessary hospital admissions, reduce hospital costs, and prevent the inadvertent release of patients with ACS. The system will improve on currently available POC CM tests by providing rapid and economical methods of quantifying multiple CMs using a portable instrument format. This will significantly improve the efficiency of CM testing, by allowing CM measurement in ambulances, doctors' offices and patients' homes, as well as convenient bedside testing in hospital emergency departments. The system comprises of two parts, a disposable electrochemical assay strip, and a hand-held device for reading and quantifying the assays. The key innovation in the proposed work is the application of rapid and convenient flow-through assay formats, combined with electrochemical biosensors that allow sensitive multi-analyte quantification. The specific aims of the Phase I are to fabricate proof-of-concept electrochemical immunoassays and demonstrate their use in simultaneously quantifying two important CMs in serum samples, myoglobin and troponin I, in serum samples. The Phase I program will demonstrate the feasibility of our system, providing proof-of-concept electrochemical assays which will be developed in Phase II into higher-density assay strips containing sensing electrodes for a wider range of CMs, together with the development of a prototype electrochemical assay reader. Rapid, portable, quantitative and economical POC tests for CMs will be valuable tools for diagnosing patients with ACS. CM POC testing is expected to grow more than 20% per year over the next several years, reaching sales of over $160 million in 2006. There is an excellent opportunity to create a niche for our technology, which has advantages over current POC tests. EIC has a clear commercial path for assay technology through in-house manufacturing, sale of electrochemical assays and hand-held assay readers, and out-licensing of our multianalyte immunoassay technology.