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床旁血液化学测量，但不能进行定量高灵敏度免疫测定测量。因此，各种危及生命的疾病（如败血症）的低水平血清标志物不能在护理点进行。IA Inc.的免疫传感器具有将免疫测定带到护理点（POC）所需的必要速度和灵敏度，但缺乏测量具有临床测定所需的传感器间再现性的一组标记物所需的内部校准和多路复用特征。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，将IA公司的生物传感器技术从研究环境扩展到临床环境，该系统可快速准确地测量血清中低浓度疾病标志物的面板。该技术平台将适用于任何血液分析物的快速测量，目前需要更耗时的免疫测定程序。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，以提供即时检测面板：传感器的自校准和多分析物功能。第二阶段将提供一组炎症标志物，如细胞因子，这是有用的诊断危及生命的条件，如败血症和心力衰竭。通过提高临床工作人员的诊断速度，早期治疗将降低患者的发病率和死亡率，以及因疾病进展更严重而产生的高昂费用。I期特定目标包括：1）开发用于数据标准化的传感器间校准方法; 2）开发测量4-6种荧光发射的仪器; 3）对2种分析物进行校准的同时测定; 4）评价用于基于抗体的测定的通用传感器表面。将探索使用量子点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.