Special Project Method Development and Method Validation Analytical Track

特殊项目方法开发和方法验证分析轨道

• 批准号: 10173201
• 负责人: Jason Siu Kong
• 金额: $ 1.34万
• 依托单位: OHIO 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/10173201
• 关键词: Special; Project; Method; Development; Validation

Increasing the Capability and Capacity of Microbiological and Chemical Testing to Support an Integrated Food Defense and Food Safety System Special Projects Discipline, Method Development and Method Validation Analytical Track Project Summary / Abstract Method development and method validation are vital to the production of new testing assays and providing defensible methods to support any corresponding regulatory action, respectively. Common prohibitors of successful single laboratory validation (SLV) and multi-laboratory validation (MLV) studies are that of poor design of experiment leading to unusable validation data or the high cost of coordinating multiple laboratories and standardizing the method across national or even international lines. In both cases these studies require a large investment of time for each participating laboratory. Nevertheless, the benefits of a validated study are worth the costs involved. The Ohio Department of Agriculture (ODA) Consumer Protection Laboratory (CPL) thus proposes in the first project period to participate in a multi-laboratory validation (MLV) study for the FDA Elemental Analysis Manual method EAM 4.12, “Mass Spectrometric Determination of 18 Elements in Bottled Water.” ODA-CPL will supply all necessary reagents, experienced personnel and logistical support to ensure their laboratory portion of work is complete. ODA-CPL will participate in any communications related to the MLV. In future project periods, ODA-CPL intends to continue method development and method validation activities and applying to perform studies for microbiological or chemical methods depending on FDA’s priorities so long as ODA-CPL’s assets and workflow are compatible.

提高能力和能力 微生物和化学测试，以支持 综合食品防御和食品安全系统 特殊项目学科、方法开发和方法验证 分析跟踪 项目总结/摘要 方法开发和方法验证对于新检测方法的生产至关重要 并提供可辩护的方法，以支持任何相应的监管行动。 成功的单个实验室验证（SLV）和多个实验室验证的常见障碍 验证（MLV）研究是指实验设计不佳导致无法使用的验证 数据或协调多个实验室和标准化方法的高成本 国内甚至国际航线。在这两种情况下，这些研究都需要大量的投资， 每个参与实验室的时间。然而，一项经过验证的研究的好处是值得的， 所涉及的费用。俄亥俄州农业部（ODA）消费者保护 因此，CPL实验室建议在第一个项目期间参加多实验室 FDA元素分析手册方法EAM 4.12“质量”的验证（MLV）研究 光谱法测定瓶装水中的18种元素。ODA-CPL将提供所有 必要的试剂、有经验的人员和后勤支助，以确保他们的实验室 部分工作已经完成。ODA-CPL将参与与以下内容相关的任何沟通： MLV。在未来的项目期间，ODA-CPL打算继续进行方法开发， 方法验证活动，并申请进行微生物或化学研究 方法取决于FDA的优先事项，只要ODA-CPL的资产和工作流程 兼容.