Matrix Extensions for the NSSP LC-MS/MS Diarrhetic Shellfish Poison Method

NSSP LC-MS/MS 腹泻性贝类中毒方法的矩阵扩展

• 批准号: 10173515
• 负责人: Shelley K Lankford
• 金额: $ 3.02万
• 依托单位: WASHINGTON STATE DEPARTMENT OF HEALTH
• 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/10173515
• 关键词: Matrix; Extensions; NSSP; LC; MS

1 Matrix Extensions for the NSSP LC-MS/MS Diarrhetic Shellfish Poison method 2 Abstract 3 4 The Washington State Public Health Laboratories (WAPHL) Biotoxin Laboratory tests more than 5 2000 samples per year from the shores of the state for Diarrhetic Shellfish Poison (DSP), 6 specifically, dinophysis toxins, a trio of lipophilic toxins produced by the Dinophysis genus of 7 dinoflagellates. DSP toxins are known to cause gastrointestinal issues in humans who consume 8 elevated levels of the toxins. The toxins that result in DSP poisoning are difficult to quantify 9 reliably due to matrix suppressions and enhancements from the various substances within 10 shellfish matrices. 11 12 Washington State is currently using a modified European Union LC-MS/MS method that is 13 generalized for the analysis of many types of lipophilic toxins. In 2017, the U.S. Food and Drug 14 Administration developed a method for DSP testing that has a greater sensitivity and specificity 15 than the EU method and this method has now been adopted into the National Shellfish 16 Sanitation Program (NSSP) for the testing of clams. It is the only DSP method fully accepted 17 into the NSSP for monitoring shellfish for diarrhetic shellfish poisoning toxins and is validated for 18 a single matrix. This method is currently approved for full regulatory testing of clams but is 19 limited to screening only of mussels and other species. The WAPHL seeks funding to perform 20 matrix extension projects for mussels and a variety of other shellfish species that are deemed to 21 be important for public health. All shellfish species that are being monitored for DSP toxins 22 under the NSSP need to be confirmed as a valid matrix prior to performing regulatory testing 23 using this method. We are planning to collaborate with the method developer, Dr. Jonathan 24 Deeds at the FDA for this project. This proposed project will follow Discipline D Special Projects, 25 Track 3: Method Development and Method Validation. Completion of this project and future 26 applications for project funding will allow laboratories nationwide to perform DSP testing that is 27 approved for regulatory use on a wide variety of shellfish species.

1用于NSSP LC-MS/MS腹泻贝类毒素方法的矩阵扩展 2摘要 3 4华盛顿州公共卫生实验室（WAPHL）生物毒素实验室检测的 每年从该州海岸采集5 2000份腹泻贝类毒素样本， 6具体地说，甲藻毒素，由甲藻属产生的三种亲脂性毒素， 7条腰鞭毛虫。DSP毒素是已知的，导致胃肠道问题的人谁消耗 8毒素含量升高导致DSP中毒的毒素很难量化 9可靠地由于基质supplies和增强从各种物质中 10个贝类基质。 11 12华盛顿州目前正在使用一种改良的欧盟LC-MS/MS方法， 13概括用于分析许多类型的亲脂性毒素。2017年，美国食品和药物管理局 14管理部门开发了一种DSP测试方法，具有更高的灵敏度和特异性 15比欧盟的方法和这种方法现已被采纳到国家贝类 16检验蛤蜊的卫生方案。它是唯一被完全接受的DSP方法 17纳入NSSP，用于监测贝类中的贝类毒素， 18个矩阵这种方法目前已被批准用于对蛤蜊进行全面的监管测试，但 19只限于筛选贻贝和其他物种。WAPHL寻求资金， 20个贻贝和其他各种贝类的基质推广项目， 21、对公众健康至关重要。正在监测DSP毒素的所有贝类物种 在执行监管测试之前，需要确认NSSP下的22项为有效矩阵 23、用这种方法我们计划与方法开发者乔纳森博士合作 在FDA为这个项目做了24个契约。本拟议项目将遵循D类特殊项目， 25轨道3：方法开发和方法验证。本项目的完成及未来 26个项目资助申请将允许全国实验室进行DSP测试， 27批准用于各种贝类的监管使用。