An Integrated, Accurate, and Rapid Peanut Allergen Detector for Consumers

 描述（由申请人提供）：痛点：这个小企业创新研究第一阶段项目提出开发一种前所未有的，一体化的手持设备，集成食品加工，分析化学和数据解释，从而使消费者能够轻松地测试他们的食物中的花生，并在未来，其他食物过敏原。在美国，食物过敏是一个日益增长的食品安全和公共卫生问题（Gupta，R. JAMA Pediatrics，2013; Liu，AH. J Allergy Clin Immunol，2010），影响6-8%的4岁以下儿童和3.7%的成人（NIH食物过敏研究专家小组报告，2006）。花生过敏是美国食物过敏相关死亡的最常见原因（Bock，S.A. J Allergy Clin Immunol，2007）。在儿童中，花生是最普遍的饮食过敏，占所有食物过敏的25%。严格的终身无花生饮食是这些患者目前唯一的治疗方法，但由于（a）食品生产和制备过程中的交叉污染和（B）标签和检测机制不足，很难坚持（Remington，B.C. Food Chem Toxicol，2013）。传统的花生测试是（1）复杂的-大多数试剂盒需要7个以上的步骤，并且某些步骤涉及用户不容易获得的设备，例如秤或研磨装置;（2）昂贵的-每次测试花费超过$14;以及（3）耗时-每次测试花费超过18分钟。从根本上说，不存在一种面向消费者的产品，花生敏感的个人可以使用它来主动确保他们的食品安全。技术创新：6SensorLabs正在建立第一个也是唯一一个快速和用户友好的解决方案，使消费者能够测试他们的食物中的膳食过敏原。一体化手持式设备NimaTM可在2分钟内对食物进行内部研磨、使用我们专有的提取溶液提取过敏原蛋白（特别是本提案中的花生蛋白）、进行免疫测定并解释结果。在内部执行所有这些操作可以显著地简化测试，最大限度地减少用户错误和变化的机会，并建立对测试结果的信心。此外，用户还可以选择通过蓝牙将测试结果自动上传到 6SensorLabs正在开发的移动的应用程序。结果将由消费者和6SensorLabs团队收集，并自动输入数据库。我们的目标是建立美国最大的过敏原（和麸质）检测结果数据库，这将成为食物过敏社区的资源，以便消费者能够做出更明智的决定，在哪里吃什么。该技术的更广泛影响是为食品敏感的个人，他们的父母或其他照顾者，医疗保健提供者和食品制造商提供测试食品的简单方法，确保食品安全和改善健康。虽然我们的前两款产品将专注于麸质和花生检测，但我们希望在不久的将来将这一技术平台扩展到其他常见食物过敏原或刺激物的检测，包括坚果、乳制品、鸡蛋和大豆等。

 DESCRIPTION (provided by applicant): Pain Point: This Small Business Innovation Research Phase I project proposes to develop an unprecedented, all-in-one handheld device that integrates food processing, assay chemistry and data interpretation, thereby allowing consumers to easily test their food for peanut and, in the future, other food allergens. Food allergies are a growing food safety and public health concern in the United States (Gupta, R. JAMA Pediatrics, 2013; Liu, AH. J Allergy Clin Immunol, 2010), affecting 6-8% of the children under 4 and 3.7% of adults (Report of the NIH Expert Panel on Food Allergy Research, 2006). Peanut allergy is the most common cause of food allergy- related fatalities in the US (Bock, S.A. J Allergy Clin Immunol, 2007). Among children, peanut is the most prevalent dietary allergy, accounting for 25% of all food allergies. A strict, and life-long peanut-free diet is the only currnt treatment for these patients, but it can be difficult to adhere to because of (a) cross-contamination during food manufacturing and preparation processes and (b) inadequate labeling and testing mechanisms (Remington, B.C. Food Chem Toxicol, 2013). Traditional peanut tests are (1) complicated - most kits require 7+ steps and certain steps involve equipment that is not readily available to the user, such as a scale or grinding device; (2) expensive - costing more than $14 per test; and (3) time consuming - taking longer than 18 min per test. Fundamentally, there does not exist a consumer-oriented product that peanut-sensitive individuals can use to proactively ensure the safety of their food. Technological Innovation: 6SensorLabs is building the first and only rapid and user-friendly solution that enables consumers to test their food for dietary allergens. The all-in-one, handheld device, NimaTM, internally grinds the food, extracts allergen proteins (specifically peanut protein under this proposal) with our proprietary extraction solution, performs the immunoassay and interprets the result, all within 2 minutes. Performing all of these operations internally significantly simplifie the test, minimizes opportunities for user error and variation, and builds confidence in the test result. Further, users will have the option to automatically upload test results via Bluetooth to a mobile app that 6SensorLabs is building. Results will be collected by both consumers and the 6SensorLabs team and automatically entered into a database. We aim to build the largest living allergen (and gluten) test result database in the US, which will serve as a resource to the community living with food allergies, so that consumers can make smarter decisions about where and what to eat. Broader Impacts of the Technology are to provide food sensitive individuals, their parents or other caregivers, health care providers, and food manufacturers with an easy means of testing foods, ensuring food safety and improving health. While our first two products will be focused on gluten and peanut detection, we expect to expand this technology platform to the detection of other common food allergens or irritants, including tree nuts, dairy products, eggs and soy, among others, in the near future.