SBIR Phase I: A Novel Immunoassay Platform for Faster and More Accurate Protein Detection

SBIR 第一阶段：一种新型免疫分析平台，可实现更快、更准确的蛋白质检测

• 批准号: 1448690
• 负责人: Lucas Smith
• 金额: $ 15万
• 依托单位: BioAnalytics Inc
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-01-01 至 2015-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1448690&HistoricalAwards=false
• 关键词: SBIR; Phase; Novel; Immunoassay; Platform

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) proposal will be the development of a simplified testing method for measuring the concentration of specific proteins within a sample for diagnostic testing. In recent years, protein quantification has begun to play an increasingly important role in medical diagnostics, academic research, and pharmaceutical development, industries that together represent a $13.8 billion global market. In each of these areas, additional steps directly contribute to 5 of the top 8 factors driving the transition to new methods including: increased error, longer testing time, higher technician costs, decreased throughput, and added complexity. The proposed technology addresses each of these areas in a broadly applicable fashion by reducing the overall number of steps by up to 50% using materials that are estimated to contribute to a mere 1% increase in the cost of each test. This is particularly relevant to the medical diagnostic industry, where speed and accuracy have an immense effect on patient treatment and therapy success. Further, the reduction in test complexity represents a key factor enabling the development of portable devices with the potential to allow for new domestic applications as well as increased access to medical testing in third world countries.This SBIR Phase I project proposes to develop a broadly applicable label-based immunoassay platform with fewer steps than conventional immunoassays. It is a well-established problem in the field that label-based immunoassays require independent antigen and detection antibody binding steps, and that single step label-free immunoassays provide significantly lower sensitivity. The proposed project aims to develop an alternative to the conventional sandwich immunoassay, which uses intramolecular binding kinetics to combine antigen and detection antibody binding steps in a fashion which allows for label based target detection following a single incubation of typical duration. This method will be initially studied using streptavidin-biotin binding as a model system to optimize complex formation and demonstrate fluorescent-based detection following a single incubation. This platform will then be applied to antibody mediated detection of the myocardial infarction indicator cardiac troponin I. This system will then be evaluated in comparison with the conventional sandwich immunoassay. At the conclusion of this research, the goal is to provide proof-of-concept data for a simplified immunoassay platform with the potential to combine immunoassay steps to provide up to two-fold improvements in speed, technician time, accuracy, throughput, and complexity.

该小型企业创新研究 (SBIR) 提案的更广泛影响/商业潜力将是开发一种简化的测试方法，用于测量诊断测试样品中特定蛋白质的浓度。近年来，蛋白质定量已开始在医疗诊断、学术研究和药物开发等行业发挥着越来越重要的作用，这些行业的全球市场规模总计达 138 亿美元。在每个领域中，额外的步骤直接导致推动向新方法过渡的 8 个主要因素中的 5 个，包括：错误增加、测试时间更长、技术人员成本更高、吞吐量降低以及复杂性增加。所提议的技术以广泛适用的方式解决了这些领域中的每一个问题，通过使用估计仅导致每次测试成本仅增加 1% 的材料，将步骤总数减少了 50%。这与医疗诊断行业尤其相关，其中速度和准确性对患者治疗和治疗成功具有巨大影响。此外，测试复杂性的降低是开发便携式设备的一个关键因素，该设备有可能允许新的国内应用，并增加第三世界国家进行医学测试的机会。该 SBIR 第一阶段项目建议开发一种广泛适用的基于标签的免疫测定平台，其步骤比传统免疫测定更少。基于标记的免疫测定需要独立的抗原和检测抗体结合步骤，并且单步无标记免疫测定提供显着较低的灵敏度，这是该领域中一个公认的问题。拟议的项目旨在开发传统夹心免疫测定的替代方法，该方法利用分子内结合动力学将抗原和检测抗体结合步骤结合起来，从而允许在典型持续时间的单次孵育后进行基于标记的目标检测。该方法最初将使用链霉亲和素-生物素结合作为模型系统进行研究，以优化复合物形成并演示单次孵育后基于荧光的检测。 然后，该平台将应用于抗体介导的心肌梗死指标心肌肌钙蛋白 I 的检测。然后将与传统的夹心免疫测定进行比较，对该系统进行评估。本研究的目标是为简化的免疫测定平台提供概念验证数据，该平台有可能结合免疫测定步骤，在速度、技术人员时间、准确性、通量和复杂性方面提供高达两倍的改进。