Food Safe Pathogen Surrogates based on encapsulated short DNA sequences for Rapid Verification of Sanitation in Food Processing

 描述（由申请人提供）：2011年，CDC估计，仅在美国，每年就有3,000人死于食源性疾病。根据2012年7月发表在《食品保护杂志》上的一项研究，治疗食物中毒的费用每年达到140亿美元，其中包括每年住院的12.8万人的医疗费用。据估计，美国经济每年的总成本超过700亿美元。减少食源性疾病的一个关键是适当的卫生条件和随后对食品加工作业的核查。如果没有有效的方法，微生物污染可能导致食品腐败，保质期缩短，食品质量下降，以及食源性疾病。 现有的卫生核查方法存在重大挑战，阻碍了其有效性，并为新方法创造了机会。生物工程的进步已经产生了一种材料，能够开发出高效，有效和低成本的卫生验证方法。这种材料是DNATrax，一种由劳伦斯利弗莫尔国家实验室开发的生物示踪剂，并被SafeTraces独家授权用于所有领域。DNATrax提供了一个机会，通过在卫生过程中使用产品作为病原体替代品来验证食品加工厂的卫生状况。这些替代物是短的DNA序列，封装在不同性质的食品安全材料中，在卫生条件下，其行为方式与其相应的靶病原体的行为密切相关。它们将在卫生过程之前使用，如果在卫生过程之后发现，则作为卫生没有得到适当执行的指标。在几分钟内检测到，基于DNATrax的代理将允许比以前更快地进行准确的卫生验证，从而能够及时进行卫生干预。DNATrax是一种安全和通用的材料，已被美国食品和药物管理局认定为一般公认安全（GRAS）食品添加剂。 该项目旨在确定开发基于DNATrax的方法的可行性，以快速有效地验证食品加工操作中的卫生是否已根据政府标准执行。具体而言，这将需要：（a）开发DNATrax作为目标病原体的单一替代物;（B）替代物的实验室评估和针对目标病原体的基准测试;以及（c）与Diagenetix合作开发用于快速、低成本检测病原体替代物的LAMP测定法。此外，该项目旨在从成本角度确定DNATrax将成为食品工业不同部门（包括小型企业）的可行技术。

 DESCRIPTION (provided by applicant): In 2011, the CDC estimated that in the U.S. alone 3,000 deaths are caused each year due to foodborne illness. The cost to treat food poisoning comes to $14 billion a year, according to a July 2012 study published in the Journal of Food Protection, including the medical expenses of the 128,000 who are hospitalized annually. The total cost to the U.S. economy is estimated to exceed $70 billion annually. One key to reducing foodborne illnesses is proper sanitation and subsequent verification in food processing operations. Without effective methods in place, microbiological contamination can result in food spoilage, reduction in shelf life and food quality, and foodborne illnesses. Existing sanitation verification methods have significant challenges that impede their effectiveness and create an opportunity for a novel approach. Advances in bioengineering have produced a material that enables the development of a highly efficient, effective, and low-cost sanitation verification method. This material is DNATrax, a biological tracer developed at Lawrence Livermore National Laboratory and exclusively licensed for all fields of use to SafeTraces. DNATrax offers an opportunity to verify sanitation in food processing plants by using the product as a pathogen surrogate during the sanitation process. These surrogates are short DNA sequences, encapsulated in food safe materials of different properties that under sanitation conditions behave in ways that correlate well to the behaviors of their corresponding target pathogens. They will be applied before the sanitation process and if found after sanitation, serve as indicator that sanitation was not performed properly. Detected within minutes, DNATrax based surrogates will allow for accurate sanitation verification more quickly than previously possible, enabling timely sanitation intervention. DNATrax is a safe and versatile material already recognized by the Food and Drug Administration as a Generally Recognized As Safe (GRAS) food additive. This project aims to establish the feasibility of developing a DNATrax-based method to rapidly and effectively verify whether sanitation in food processing operations has been executed according to governmental standards. Specifically this will entail: (a) the development of DNATrax as a single surrogate for a target pathogen; (b) the laboratory evaluation of the surrogate and benchmarking against the target pathogen; and (c) the development of a LAMP assay for fast, low-cost detection of pathogen surrogates in collaboration with Diagenetix. In addition, the project aims to establish that from a cost perspective, DNATrax will be a viable technology for different sectors of the food industry, including small businesses.