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仅在大量收集样品材料后运行。不幸的是，这增加了患者收到测试结果或医生计划治疗过程的时间。目前的护理点检测（POCT）免疫测定系统提供快速结果，但它们以其较差的准确性和灵敏度而闻名，并且通常限于定性或半定量测定。MSI提出开发一种便携式集成POCT系统，通过将自包含的小型化化学发光芯片（CLCHIP）和微流体技术相结合，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微流体，用于多分析物和多步骤生物化学，并将复杂的过程减少到一个步骤。在本项目的第一阶段，我们设计和制作了微流控生物芯片与图案化的微通道，开发了一个芯片上的化学发光免疫分析方案，进行了促黄体生成素和肌钙蛋白I的生物测定，获得了线性的剂量-响应曲线，并实现了15分钟的总测定时间。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，进行各种分析物检测，多分析物面板检测，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.