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

为消费者提供集成、准确、快速的花生过敏原检测仪

• 批准号: 9515756
• 负责人: Francisco Javier Dias Lourenco
• 金额: $ 100万
• 依托单位: NIMA LABS, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-02-01 至 2019-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9515756
• 关键词: 4 year old; Accounting; Adult; Affect; Affinity; Allergens; Allergy to peanuts; Antibodies; Biological Assay; Bluetooth; Caregivers; Chemistry; Child; Communities; Complex; Consumption; Custom; Dairy Products; Data Analyses; Databases; Detection; Devices; Diet; Disease Notification; Eating; Ensure; Equipment; Evaluation; Fluorescence; Food; Food Hypersensitivity; Food Processing; Food Safety; Funding; Future; Generations; Gluten; Government; Guidelines; Health; Health Personnel; High Prevalence; Hypersensitivity; Immunoassay; Individual; Irritants; Label; Lateral; Lead; Life; Manufacturer Name; Medical Care Costs; National Institute of Allergy and Infectious Disease; Nuts; Pain; Parents; Patients; Pediatrics; Performance; Persons; Phase; Population; Preparation; Prevalence; Price; Process; Proteins; Public Health; Quality of life; Reporting; Research; Resources; Restaurants; Safety; Sampling; Small Business Innovation Research Grant; Technology; Test Result; Testing; Time; Trees; United States; United States National Institutes of Health; Variant; base; cloud based; community living; cost; data exchange; data sharing; design; detector; egg; food allergen; handheld equipment; improved; mobile application; operation; portability; programs; prototype; sensor; soy; technological innovation; user-friendly

Pain Point: This Small Business Innovation Research Phase II 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 lifelong peanut-free diet is the only current 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: Nima 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 Nima’s proprietary extraction solution, performs the immunoassay and interprets the result, all within 3 minutes. Performing all of these operations internally significantly simplifies 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 Nima is building. Results will be collected by both consumers and the Nima team and automatically entered into a database. Nima aims 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 Nima’s first product (now on the market) focused on gluten detection and the second will focus on peanut detection, this technology platform is expected to expand to the detection of other common food allergens or irritants, including tree nuts, dairy products, eggs and soy, among others.

痛点：这个小企业创新研究第二阶段项目建议开发一个前所未有的， 一种集食品加工、化验化学和数据解释于一体的手持式设备， 使消费者能够方便地测试他们的食物中的花生，并在未来，其他食物过敏原。食物过敏 在美国，食品安全和公共卫生问题日益严重（Gupta，R. JAMA Pediatrics，2013; Liu， 啊J Allergy Clin Immunol，2010），影响6-8%的4岁以下儿童和3.7%的成年人（2010年的报告）。 NIH食物过敏研究专家小组，2006年）。花生过敏是食物过敏最常见的原因- 美国相关死亡事件（Bock，S.A. J Allergy Clin Immunol，2007）。在儿童中，花生是最多的 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 只有目前的治疗这些患者，但它可能很难坚持，因为（a）交叉污染 （B）标签和检测机制不充分 （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+步骤和某些步骤涉及用户不容易获得的设备，例如秤或研磨 设备;（2）昂贵-每次测试花费超过14美元;（3）耗时-每次测试花费超过18分钟 test.从根本上说，不存在一个面向消费者的产品，花生敏感的个人可以 以确保他们的食品安全。 技术创新：Nima正在构建第一个也是唯一一个快速且用户友好的解决方案， 消费者测试他们的食物的膳食过敏原。一体化手持式设备NimaTM可在内部进行研磨 食品，提取过敏原蛋白质（特别是花生蛋白根据这一建议）与尼玛的专有 提取溶液，进行免疫测定并解释结果，所有这些都在3分钟内完成。执行所有 这些操作的内部显著简化了测试，最大限度地减少了用户错误的机会， 并建立对测试结果的信心。此外，用户还可以选择自动上传 通过蓝牙将测试结果发送到Nima正在开发的移动的应用程序。结果将由双方消费者收集 和尼玛团队的数据自动输入数据库。尼玛的目标是建立最大的生活过敏原 (and面筋）测试结果数据库，这将作为一个资源，以社区生活的食物 过敏，这样消费者就可以做出更明智的决定在哪里吃什么。 这项技术的更广泛影响是为对食物敏感的个人、他们的父母或其他人提供食物。 护理人员、卫生保健提供者和食品制造商，通过简单的方法测试食品， 安全和改善健康。虽然尼玛的第一个产品（现在市场上）专注于面筋检测， 二是将重点放在花生检测上，这一技术平台有望扩展到花生检测领域。 其他常见的食物过敏原或刺激物，包括坚果、乳制品、鸡蛋和大豆等。