Chemiluminescence Biochip for Immunoassay

描述（由申请人提供）：目前用于临床诊断的集成模块化系统只有在大量收集样品材料后才能运行。不幸的是，这增加了患者收到检查结果或医生计划疗程的时间。目前的即时检测（POCT）免疫分析系统提供快速结果，但其准确性和敏感性较差，并且通常仅限于定性或半定量分析。MSI提出开发一种便携式集成POCT系统，通过结合一个独立的，小型化的化学发光芯片（CLCHIP）和微流控技术，将大大提高POCT的准确性，灵敏度和可靠性。这种创新的CLCHIP平台利用微加工技术自动化多分析物和多步骤生物化学的微流体，并将复杂的程序减少到一个步骤。在本项目一期中，我们设计并制作了带有图像化微通道的微流控生物芯片，开发了片上化学发光免疫分析方案，进行了黄体生成素和肌钙蛋白I的生物测定，获得了线性剂量响应曲线，总测定时间为15分钟。在I期的基础上，我们将进入II期，以优化CLCHIP的开发，完成系统集成，进行各种分析物分析，多分析物面板测试，并达到临床性能要求。

DESCRIPTION (provided by applicant): Current integrated modular systems for clinical diagnostics only operate after a large collection of sample material. Unfortunately, this increases the amount of time for patients to receive their test results or physicians to plan a course of treatment. Present day point-of-care-testing (POCT) immunoassay systems provide rapid results, but they are known for their poor accuracy and sensitivity, and often limited to qualitative or semi-quantitative assays. MSI has proposed to develop a portable, integrated, POCT system, by combining a self-contained, miniaturized chemiluminescence chip (CLCHIP) and microfluidic technologies that will dramatically improve POCT accuracy, sensitivity, and reliability. This innovative CLCHIP platform utilizes microfabrication technology to automate microfluidics for multi-analyte and multi-step biochemistries and reduce a complicated procedure to a single step. During Phase I of this project, we designed and fabricated microfluidic biochips with patterned microchannels, developed an on-chip chemiluminescence immunoassay protocol, performed a luteinizing hormone and troponin I bioassay, obtained linear dose-response curves, and achieved a total assay time of 15 minutes. Based on the foundation of Phase I we will move into Phase II, in order to optimize CLCHIP development, complete system integration, perform various analyte assays, multi-analyte panel testing, and achieve clinical performance requirements.