Rapid Quantitative Point-of-Care Cardiac Marker Test

快速定量护理点心脏标志物测试

• 批准号: 6883456
• 负责人: MICHAEL S WILSON
• 金额: $ 15.04万
• 依托单位: EIC LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-02-01 至 2006-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6883456
• 关键词: biomarker; biomedical equipment development; blood chemistry; cellulose; consumable /disposable biomedical equipment; coronary disorder; diagnosis design /evaluation; electrochemistry; electrodes; gold; heart disorder diagnosis; immunologic assay /test; method development; myoglobin; nitrogen compounds; portable biomedical equipment; protein quantitation /detection; rapid diagnosis; troponin

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.

描述（由申请人提供）：拟开发一种便携式、快速和定量床旁（POC）系统，用于评价潜在急性冠状动脉综合征（ACS）患者。该系统将用于通过测量多种心脏标志物（CM）浓度来快速对胸痛患者进行分类。该系统将在急诊室、医生办公室和救护车中用于快速识别ACS患者，并将减少不必要的住院，降低医院成本，并防止ACS患者的意外释放。该系统将通过使用便携式仪器格式提供快速和经济的量化多种CM的方法来改进目前可用的POC CM测试。这将大大提高CM测试的效率，允许在救护车，医生办公室和病人家中进行CM测量，以及在医院急诊室进行方便的床边测试。该系统包括两个部分，一次性电化学测定条和用于阅读和定量测定的手持装置。在拟议的工作中的关键创新是应用快速和方便的流通测定格式，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电化学免疫测定，并证明其在同时定量血清样本中的两种重要CM（血清样本中的肌红蛋白和肌钙蛋白I）中的用途。第一阶段计划将证明我们的系统的可行性，提供概念验证的电化学检测，将在第二阶段开发成更高密度的检测条，其中包含用于更广泛的CM的传感电极，以及原型电化学检测读取器的开发。快速，便携，定量和经济的POC测试CM将是诊断ACS患者的有价值的工具。CM POC测试预计在未来几年内每年增长20%以上，2006年销售额将超过1.6亿美元。这是一个为我们的技术创造一个利基市场的绝佳机会，它比目前的POC测试具有优势。EIC通过内部制造、电化学分析和手持式分析读取器的销售以及多分析物免疫分析技术的外部许可，为分析技术提供了明确的商业途径。