SBIR Phase I: Consumer Food Allergen Detection Instrument

这个小企业创新研究（SBIR）项目的更广泛的影响/商业潜力是开发第一个消费者手持仪器，用于准确和快速检测食品中的过敏原。这项技术将使人们能够在食用之前立即检测食物中是否存在需要避免的食物过敏原。目标市场是1500万美国人和1.5亿全球食物过敏人群。预计这项技术将对这些人的健康和生活质量产生重大影响。正在开发的新型检测平台可以实现即时检测，并具有许多固有优势，包括使用快速，可重复和可扩展的过程进行修改的能力。它体积小，制造成本低，易于批量生产，并且在一系列化学和环境条件下都很稳定。所有这些都使该检测平台最适合在消费者设备中进行即时检测。通过将这种检测平台整合到仪器和一次性用品中，以受控的方式对食物进行取样，提取蛋白质，检测目标蛋白质水平并清晰显示结果，人们相信这是一项颠覆性技术，将从根本上改变人们管理食物过敏的方式。这个SBIR一期项目提议开发一种食品过敏原检测平台，这是一种手持式消费者仪器，可以在一分钟内对食品进行取样，提取蛋白质，并在临床定义的阈值下检测过敏原的存在。它是基于设计的具有高特异性和选择性结合的信号过敏原特异性小分子，用于检测微量食物过敏原浓度。此外，检测仪器的所有子系统都包含在设计中，可以对食品进行取样，通过化学和物理均质提取蛋白质，并检测食品过敏原的存在。在第一阶段的研究中，采样、均质和检测机制将集成到手持消费仪器中。需要解决的三大挑战将是：1)优化设计，并测试功能齐全的仪器；2)将检测平台与仪器集成；3)优化食品抽样机制。成功地解决这三个目标并创建一个功能齐全的原型，不仅可以实现消费品的商业化，可以立即检测食物过敏原，而且可以作为未来即时诊断能力的概念验证。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) project is to develop the first consumer hand-held instrument for the accurate and immediate detection of allergens in food. This technology will enable people to test their food immediately prior to consumption for the presence of food allergens that they need to avoid. The target market is the 15 million people in the US and 150 million people worldwide who have food allergies. It is anticipated that this technology will have a significant impact on health and quality of life of these individuals. The novel detection platform under development enables instant detection and has many intrinsic advantages including the ability to be modified using a fast, reproducible, and scalable process. It is small and inexpensive to manufacture, is easily mass produced and is stable over a range of chemical and environmental conditions. All of these make this detection platform optimal for immediate detection in a consumer device. By incorporating this detection platform into an instrument and disposables that will sample food in a controlled way, extract proteins, detect target protein levels and clearly display the result, it is believed that this is a disruptive technology that will fundamentally change how people manage their food allergies.This SBIR Phase I project proposes to develop a food allergen detection platform that is a hand-held consumer instrument that samples food, extracts protein, and detects the presence of an allergen at a clinically defined threshold in under a minute. It is based on designed signaling allergen-specific small molecules that bind with high specificity and selectivity, and are utilized for testing minute concentrations of food allergens. In addition, all subsystems of the detection instrument that can sample food, extract protein by chemical and physical homogenization and test for the presence of food allergens are included in the design. In this Phase I study, the sampling, homogenization, and detection mechanism will be integrated into a hand-held consumer instrument. The three major challenges to be addressed will be 1) Optimize the design, and test the fully functional instrument; 2) Integrate the detection platform with the instrument; and 3) optimize the food sampling mechanism. Successfully addressing these three goals and creating a fully functional prototype will not only enable the commercialization of a consumer product that can instantly detect food allergens but also may serve as proof-of-concept for future point-of-care diagnostic capabilities.