Rapid Quantitative Point-of-Care Cardiac Marker Test

描述(由申请人提供)：建议开发一种便携式、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个心脏标志物(CM)浓度来对胸痛患者进行快速分诊。该系统将用于急诊科、医生办公室和救护车，用于快速识别急性冠脉综合征患者，并将减少不必要的入院人数，降低医院成本，防止急性冠脉综合征患者无意中出院。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CMS。这将大大提高CM测试的效率，因为它允许在救护车、医生办公室和病人家中进行CM测量，以及在医院急诊科进行方便的床边测试。该系统由两部分组成，一是一次性电化学分析试纸，二是用于读取和定量分析的手持设备。拟议工作中的关键创新是应用快速和方便的流动分析格式，并结合允许灵敏的多分析物定量的电化学生物传感器。第一阶段的具体目标是制造概念验证电化学免疫分析方法，并演示它们在同时定量血清样本中的两种重要的CMS--血清样本中的肌红蛋白和肌钙蛋白I--中的用途。第一阶段计划将展示我们系统的可行性，提供概念验证电化学分析，将在第二阶段开发成包含用于更广泛CMS的传感电极的更高密度的分析条，以及开发原型电化学分析读取器。快速、便携、定量、经济的CMS POC检测将成为诊断急性冠脉综合征的有价值的工具。预计CM PoC测试在未来几年将以每年20%以上的速度增长，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，我们的技术比目前的PoC测试更具优势。EIC通过内部制造、销售电化学检测和手持检测读取器，以及我们的多分析免疫检测技术的外部许可，为检测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.