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: 9409655
• 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 2018-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9409655
• 关键词: 4 year old; Accounting; Adult; Affect; Affinity; Allergens; Allergy to peanuts; Antibodies; Biological Assay; Caregivers; Chemistry; Child; Communities; Complex; Consumption; Custom; Dairy Products; Data Analyses; Databases; Detection; Devices; Diet; 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; 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提出开发一个前所未有的、 集食品加工、化学分析和数据解释于一体的一体化手持设备，从而 使消费者能够轻松测试食品中的花生以及未来的其他食物过敏原。 是美国日益关注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（报告 NIH 食物过敏研究专家小组，2006 年）。 在美国，相关死亡人数最多（Bock，S.A. J Allergy Clin Immunol，2007 年）。 普遍的饮食过敏，占所有食物过敏的 25%，严格且终身不吃花生的饮食是最重要的。 这些患者目前只能接受治疗，但由于 (a) 交叉污染，可能很难坚持治疗 在食品制造和制备过程中以及 (b) 标签和测试机制不完善 （Remington，BC Food Chem Toxicol，2013 年）传统的花生测试 (1) 很复杂 – 大多数试剂盒都需要。 7 个以上步骤和某些步骤涉及用户不易获得的设备，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——每次测试时间超过 18 分钟； 从根本上说，不存在一种可供对花生敏感的人进行测试的面向消费者的产品。 用于主动确保食品安全。 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，该解决方案使 消费者可以使用一体式手持设备 NimaTM 进行内部研磨，以测试其食物中的膳食过敏原。 使用 Nima 的专有技术从食物中提取过敏原蛋白（特别是本提案中的花生蛋白） 提取溶液、进行免疫测定并解释结果，全部在 3 分钟内完成。 这些操作在内部显着简化了测试，最大限度地减少了用户出错的机会， 此外，用户还可以选择自动上传。 测试结果通过蓝牙发送到 Nima 正在构建的移动应用程序 结果将由两个消费者收集。 尼玛团队并自动输入数据库，尼玛的目标是建立最大的活体过敏原。 美国（和麸质）测试结果数据库，将作为食物社区的资源 过敏，以便消费者可以更明智地决定去哪里吃、吃什么。 该技术的更广泛影响是为食品敏感的个人、他们的父母或其他人提供 为护理人员、医疗保健提供者和食品制造商提供简单的食品检测方法，确保食品安全 而 Nima 的第一个产品（现已上市）专注于麸质检测和 第二个将专注于花生检测，该技术平台有望扩展到花生检测 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。