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系统仅在收集大量样本材料后才能运行。不幸的是，这增加了患者收到检测结果或医生计划疗程的时间。目前的POCT免疫检测系统提供快速结果，但它们的准确性和灵敏度较差，通常仅限于定性或半定量分析。微星公司建议开发一种便携式、集成化的POCT系统，将自给自足的微型化学发光芯片(CLCHIP)与微流控技术相结合，将显著提高POCT的准确性、灵敏度和可靠性。这一创新的CLCHIP平台利用微制造技术实现了多分析物和多步骤生物化学的微流控自动化，并将复杂的程序简化为一步。在该项目的第一阶段，我们设计和制造了具有图案化微通道的微流控生物芯片，开发了芯片上化学发光免疫分析方法，进行了黄体生成素和肌钙蛋白I的生物测定，获得了线性的剂量-反应曲线，总测定时间为15分钟。在第一阶段的基础上，我们将进入第二阶段，以优化CLCHIP开发，完成系统集成，执行各种分析物分析，多分析物小组测试，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.