SBIR Phase I: Electrochemical BioDetection Platform Utilizing Disposable Microfluidic Cartridges

该小型企业创新研究第一阶段项目旨在开发一种手持式自动化生物传感器，用于对液体样品中的蛋白质和/或致病细胞进行特异性和灵敏度检测和定量。该生物传感器将高度特异性的免疫诊断与微流体格式的超灵敏电化学传感器相结合，并具有以下特点：（1）定量检测任何液体样品中的致病菌和蛋白质标志物，（2）检测限低（即病原体小于100 cfu/ml，蛋白质小于0.1 ng/ml），（3）测定时间短（即，对于细菌细胞少于25分钟，对于蛋白质少于10分钟），（4）单键、全自动操作，需要最少的用户交互，以及（5）手持，电池供电的操作允许其在远程位置使用。在第一期计划中，该系统的效用将透过检测大肠杆菌（代表性病原体）和免疫球蛋白G（代表性蛋白质/免疫标记物）而展示，而拟议产品的商业用途将包括健康诊所和移动的实验室、对可能发生的生物战威胁的紧急反应、微生物学实验室和环境监测。 手持式生物检测系统将能够在短时间内快速定量极低浓度的任何生物制剂的存在。

This Small Business Innovation Research Phase I project aims to develop a handheld automated biosensor for specific and sensitive detection and quantification of proteins and/or pathogenic cells in liquid samples. The biosensor will integrate highly-specific immunodiagnostics with ultra-sensitive electrochemical sensors in a microfluidic format, and will have the following features: (1) Quantitative detection of pathogenic bacteria and protein markers in any liquid sample, (2) Low detection limit (i.e. less than 100 cfu/ml for pathogens and less than 0.1 ng/ml for proteins), (3) Short assay times (i.e. less than 25 minutes for bacterial cells and less than 10 minutes for proteins), (4) Single-button, fully-automated operation requiring minimal user interaction, and (5) Handheld, battery powered operation allowing its use in remote locations. In this Phase I project, the utility of the system will be demonstrated by detecting Escherichia coli (a representative pathogen) and Immunoglobulin G (a representative protein/immuno marker).The commercial applications of the proposed product would include health clinics and mobile laboratories, emergency response to a possible biological warfare threat, microbiology laboratories and environmental monitoring. The handheld biological detection system will be capable of rapidly quantifying the presence of extremely low concentrations of any biological agent in a short amount of time.