Discipline D Special Project - Track 3: Method Development and Validation

学科 D 特别项目 - 第 3 轨道：方法开发和验证

• 批准号: 10173388
• 负责人: Yong Liu
• 金额: $ 3.5万
• 依托单位: WA STATE DEPARTMENT OF AGRICULTURE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10173388
• 关键词: Discipline; Special; Project; Track; Method

PAR-20-105: Discipline D – Special Projects - Track 3: Method Validation Project Summary The Washington State Department of Agriculture (WSDA) Food Safety and Consumer Services (FS&CS) Laboratory is the State’s Primary Regulatory Human Food and Animal Feed Safety Laboratory. We seek 5 years of funding through the FDA Laboratory Flexible Funding Model (LFFM) Cooperative Agreement Program’s Discipline D Special Projects Track 3, Method Development and Validation. We plan to utilize the funding to conduct preliminary, short-term or exploratory investigations that focus on the feasibility of a new method and/or technology. We propose to be part of the multi-laboratory validation of a qPCR screening method for Salmonella in foods in Year-1.  The FS&CS Laboratory has two decades of recent work developing new methods and validating the methods. From 2001-2013 the laboratory was one of 8 selected state agriculture laboratories for support under the USDA Microbiological Data Program. The purpose of this program was to develop and validate testing methods for fresh produce. Another purpose was to understand the frequency of detected pathogens in various produce items.  The Laboratory has extensive experience working with complicated matrices that present challenges to modern technical testing platforms. For instance, sprouts are difficult to test since there is a lot of interference with real-time PCR.  Each method for Salmonella, Listeria, E.coli O157:H7, non-O157 E.coli (STEC), Shigella had to be adapted to testing produce. This required years of work to discover, verify and validate the methods. Each matrix then had to be re-verified and validated.  The Laboratory has worked under the FDA FERN MCAP for over 10 years. A primary goal of this cooperative agreement is to develop testing methods on newer test platforms and then validate those methods. In addition, we have a long history of collaborating with private companies who manufacture test kits and analytical equipment, in order to get some of these technologies approved by AOAC and available for our commercial use.  The Laboratory utilizes the FDA Guideline for the Validation of Analytical Methods. If our Track 3 proposal is accepted, we are willing and able to do the following: 1. Participate the multi-laboratory validation of a qPCR screening method for Salmonella in foods by following FDA guidelines for method validation. Washington State Department of Agriculture, Food Safety and Consumer Services Laboratory

PAR-20-105：学科 D – 特殊项目 – 第 3 轨：方法验证 项目概要 华盛顿州农业部 (WSDA) 食品安全和消费者服务 (FS&CS) 实验室是州主要监管人类食品和动物饲料安全 实验室。我们通过 FDA 实验室灵活资助模式 (LFFM) 寻求 5 年的资助 合作协议计划的学科 D 特别项目轨道 3，方法开发和 验证。我们计划利用这笔资金进行初步、短期或探索性的研究 重点关注新方法和/或技术的可行性的调查。我们提议参与 第一年食品中沙门氏菌 qPCR 筛查方法的多实验室验证。  FS&CS 实验室最近二十年致力于开发新方法并验证 的方法。 2001-2013年该实验室是8个选定的国家农业实验室之一 以获得美国农业部微生物数据计划的支持。该计划的目的是 开发并验证新鲜农产品的测试方法。另一个目的是了解 各种农产品中检测到病原体的频率。  该实验室在处理复杂矩阵方面拥有丰富的经验 现代技术测试平台面临的挑战。例如，豆芽很难测试，因为 实时 PCR 存在很多干扰。  针对沙门氏菌、李斯特菌、大肠杆菌 O157:H7、非 O157 大肠杆菌 (STEC)、志贺氏菌的每种方法都必须 适应测试产品。这需要多年的工作来发现、验证和验证 方法。然后必须重新验证和验证每个矩阵。  该实验室已在 FDA FERN MCAP 下工作了 10 多年。这样做的一个主要目标 合作协议是在较新的测试平台上开发测试方法，然后进行验证 那些方法。此外，我们与私营公司有着悠久的合作历史， 制造测试套件和分析设备，以获得其中一些技术 经 AOAC 批准并可供我们商业使用。  实验室采用 FDA 分析方法验证指南。 如果我们的第三轨提案被接受，我们愿意并且能够做到以下几点： 1. 参与食品中沙门氏菌qPCR筛查方法的多实验室验证 遵循 FDA 方法验证指南。 华盛顿州农业部食品安全和消费者服务实验室