Self-Calibrating Biosensor Array for Rapid Point-of-care Diagnosis

描述(由申请人提供)：虽然现在可以在临床环境中进行常规的护理点血化学测量，但定量的高灵敏度免疫分析测量不能。因此，各种危及生命的疾病的低水平血清标志物，如败血症，不能在护理时进行。IA Inc.的S免疫传感器具有将免疫分析引入护理点(POC)所需的速度和灵敏度，但缺乏测量一组标志物所需的内部校准和多路复用功能，以及临床分析所需的传感器间重复性。该项目的目标是通过开发一种自校准、多分析物生物传感器系统，快速准确地测量血清中的低浓度疾病标志物，将IA公司的生物传感器技术从研究环境扩展到临床环境。该技术平台将适用于目前需要更耗时的免疫分析程序的任何血液分析物的快速测量。该项目将侧重于开发必须添加到现有技术平台的两个功能，以便提供一个护理小组：传感器的自我校准和多分析物能力。第二阶段将提供一组炎症标记物，如细胞因子，这些标记物对脓毒症和心力衰竭等危及生命的疾病的诊断很有用。通过提高临床工作人员进行诊断的速度，更早的治疗将减少患者的发病率和死亡率，以及更严重的疾病进展所带来的高昂成本。第一阶段的具体目标包括：1)开发数据归一化的传感器间校准方法；2)开发一种测量4-6个荧光发射的仪器；3)同时进行2种分析物的校准分析；4)评估用于基于抗体的分析的通用传感器表面。将探索使用量子点来实现校准和多路复用。

DESCRIPTION (provided by applicant): While routine point-of-care blood chemistry measurements can now be performed in clinical settings, quantitative high-sensitivity immunoassay measurements cannot. Thus, low-level serum markers for a variety of life-threatening conditions, such as sepsis, cannot be performed at the point of care. IA Inc.'s immunosensors possess the requisite speed and sensitivity needed to bring immunoassay to the point-of- care (POC), but lack the internal calibration and multiplexing features needed for measuring a panel of markers with the inter-sensor reproducibility required for clinical assays. The goal of this project is to extend IA, Inc's biosensor technology from the research environment into clinical settings by developing a self-calibrating, multi-analyte biosensor system which rapidly and accurately measures panels of low concentration disease markers in serum. The technology platform will be adaptable for rapid measurement of any blood analyte that currently requires more time-consuming immunoassay procedures. This project will focus on developing the two features that must be added to the existing technology platform in order to provide a point-of-care panel: self-calibration of sensors and multi-analyte capability. Phase II will provide a panel of inflammatory markers, such as cytokines, which are useful for diagnosis of life-threatening conditions such as sepsis and heart failure. By improving the speed with which clinical staff can make diagnosis, earlier treatment will reduce patient morbidity and mortality as well as the high cost incurred by more advanced disease progression. The Phase I Specific Aims include: 1) Develop inter-sensor calibration methods for data normalization; 2) Develop an instrument to measure 4-6 fluorescent emissions; 3) Perform calibrated simultaneous assay of 2 analytes; 4) Evaluate a universal sensor surface for use in antibody-based assays. The use of quantum dots for achieving calibration and multiplexing will be explored.