SBIR Phase I: Electrochemical BioDetection Platform Utilizing Disposable Microfluidic Cartridges

这个小型企业创新研究第一阶段项目旨在开发一种手持自动生物传感器，用于特定和灵敏地检测和量化液体样本中的蛋白质和/或致病细胞。该生物传感器将以微流控形式将高度特异的免疫诊断与超灵敏的电化学传感器集成在一起，并将具有以下特征：(1)对任何液体样本中的病原体和蛋白质标志物进行定量检测，(2)低检测下限(即，病原体小于100cfu/ml，蛋白质小于0.1 ng/ml)，(3)较短的分析时间(即，细菌细胞小于25分钟，蛋白质小于10分钟)，(4)需要最少用户交互的单键、全自动操作，以及(5)手持，电池供电操作，允许其在偏远地区使用。在这个第一阶段的项目中，该系统的实用性将通过检测大肠杆菌(一种代表性的病原体)和免疫球蛋白G(一种代表性的蛋白质/免疫标记物)来展示。建议的产品的商业应用将包括卫生诊所和流动实验室、对可能的生物战威胁的紧急反应、微生物学实验室和环境监测。手持生物检测系统将能够在短时间内快速量化存在的极低浓度的任何生物制剂。

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.