An Integrated, Accurate, Rapid, and Inexpensive Handheld Consumer Gluten Detector

 描述（由申请人提供）：一种集成的、准确的、快速的和廉价的手持式消费者麸质检测器痛点：1%的美国人口患有乳糜泻（Han，2013 PNAS 110：pp.13073），另外6%患有某种形式的对膳食麸质的不耐受（Sapone，2012 BMC Medicine 10：pp.13）。此外，3.7%的成年人和6-8%的4岁以下儿童有食物过敏。食物过敏占过敏反应急诊室就诊的35-50%（NIAID 2006年报告）。特别是对于麸质，尽管无麸质选择的可用性增加，但消费者继续因无意的麸质摄入而生病，这主要是由于食品制造和制备过程中食品的交叉污染，以及不充分的食品标签和测试机制（Thompson，2010 J Am Diet Asynchronous 110：pp.937）。传统的面筋测试是（1）复杂的-具有多个处理步骤和难以解释的结果;（2）昂贵的-每次测试花费12.5至16美元;和（3）耗时-每次测试花费>15分钟。目前，没有面向消费者的产品，面筋敏感的个人可以使用，以确保他们的食品安全。技术创新：我们的解决方案是一款名为NimaTM的一体化手持设备，它集成了食品加工、麸质检测、结果解释和数据传输，从而使消费者能够轻松地检测食物中的过敏原。这项测试不仅可以让消费者在家中烹饪或外出就餐时验证食品的安全性，还可以让父母放心、安全地在家为孩子提供食品。消费者只需要将少量样品（约0.5克）放入一次性卡匣中，然后将其插入读取器。该设备在内部研磨食物，用我们专有的提取溶液提取面筋，并进行免疫测定。然后，内置的阅读器分析测试条，给用户一个二进制结果，这是基于FDA定义的20 ppm谷蛋白的阈值。我们的设备有望分析简单和复杂食品基质中的面筋含量，检测限< 5 ppm，总检测时间< 2分钟。我们还计划建立美国最大的活体谷蛋白测试结果数据库，该数据库将与我们的移动的应用程序对接，作为无谷蛋白社区的资源。测试结果将由消费者以及6SensorLabs的专业人员生成。该数据库将帮助消费者识别可靠的无麸质食品、商店、制造商和餐馆，从而激励食品制造商和其他食品供应商更好地遵守无麸质做法。该技术的更广泛影响是为食品敏感个人，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，确保食品安全和改善健康的简单方法。虽然我们的第一款产品将专注于麸质检测，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，包括花生、坚果、乳制品、鸡蛋、大豆等。

 DESCRIPTION (provided by applicant): An Integrated, Accurate, Rapid and Inexpensive Handheld Consumer Gluten Detector Pain Point: 1% of the US population suffers from celiac disease (Han, 2013 PNAS 110: pp.13073), and an additional 6% suffers from some form of intolerance to dietary gluten (Sapone, 2012 BMC Medicine 10: pp.13). In addition, 3.7% of adults and 6-8% of children under 4 have food allergies. Food allergy accounts for 35-50% of emergency room visits for anaphylaxis (NIAID 2006 report). Specifically for gluten, despite the increasing availability of gluten-free options, consumers continue to become ill from unintentional gluten ingestion, largely due to cross-contamination of foodstuffs during food manufacturing and preparation processes, and inadequate food labeling and testing mechanisms (Thompson, 2010 J Am Diet Assoc 110:pp.937). Traditional gluten tests are (1) complicated - with multiple processing steps and results that are difficult to interpret; (2) expensive - costing $12.5 to $16 per test; and (3) time consuming - taking >15 min per test. Currently, there is no consumer-oriented product that gluten sensitive individuals can use to ensure their food safety. Technological Innovation: Our solution is an all-in-one, handheld device, called the NimaTM, which integrates food processing, gluten detection, result interpretation, and data transmission, thereby allowing consumers to easily test their food for allergens. This test will not only enable consumers to verify the safety of foods while cooking at home or dining out, but also allow parents to confidently and safely provide food for their children at home. Consumers only need to put a small sample (~0.5 grams) into the disposable cassette, which is then inserted into the reader. The device internally grinds the food, extracts the gluten with our propriety extraction solution, and performs the immunoassay. The built-in reader then analyzes the test strip, giving the user a binary result, which is based upon the FDA-defined threshold of 20 ppm gluten. Our device is expected to analyze gluten content in both simple and complex food matrices, with a Limit of Detection < 5 ppm and Overall Detection Time < 2 minutes. We also aim to build the largest living gluten-test result database in the US, which will interface with our mobile app as a resource to the gluten-free community. Test results will be generated by consumers, as well as professionals from 6SensorLabs. The database will help consumers identify reliable gluten-free foods, stores, manufacturers and restaurants which will, in turn, incentivize food manufactures and other food providers to better adhere to gluten-free practices. 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 product will be focused on gluten detection, we expect to expand this technology platform to the detection of other common food allergens or irritants, including peanuts, tree nuts, dairy products, eggs, soy, among others, in the near future.