Expanded Testing Methods for Elements and Metals in Animal Diagnostic Specimens

1项目总结：FDA目前缺乏死前(LIVE)的标准化方法 动物)和死后分析可能与以下疾病有关的动物诊断标本 3动物性食品/饲料污染事件。为了弥补这一差距，现有的FDA方法必须 4扩展到检测新的基质，如牛奶、尿液、血液和组织。目的 这个项目是为了验证测定痕量(宏观和微观)的分析方法。 6动物诊断样品中的元素、重金属和稀土元素污染。一个 2011-2012年进行的7项调查显示，全国范围内发生的50多起污染事件归因于 8微量元素和重金属，如铜、硫、铅、砷、锌、硒和 9磷。此外，FDA在2009-2012年期间召回的动物饲料包括 锌、钾、铜和钼的10起污染事件。最后，稀土 11个元素已被证明有助于追踪可疑的食品运输/反馈到特定的 12个制造商、供应商和地理区域。兽医诊断协会 这项提案包括来自华盛顿、爱达荷州、怀俄明州和犹他州的13个实验室 14有丰富经验的动物污染事件与长期存在的矿物有关 15美国西部的采矿业。所有实验室将使用已建立的微波炉 16消解和电感耦合等离子体质谱(ICP-MS)方法。跟随 17 FDA指南，牵头实验室(华盛顿动物疾病诊断实验室- 18个分析科学实验室)将在动物身上产生均匀和稳定的测试材料 19饲料、动物组织(肝、肾、脑)、血液、牛奶和尿液(4 常量元素、微量元素、重金属和稀土元素)。对于每个 21分析物方法，性能标准将记录在准确性、精密度、选择性、 22检出限、定量限、线性、量程、测量不确定度和 23粗犷。怀俄明州和犹他州的联合实验室将使用标准化方法 在项目期间开发的24个样本分析作为盲法确定未知数 25重复性和可重复性。最终数据将使用AOAC 2002指南进行分析 26化学方法和最终结果的验证在整个VET-LIRN中传达。这个 27合作协议的结果将增加所需的有效方法套件 28个动物诊断样本，以提高FDA的能力和反应能力 29起动物性食品/饲料污染事件。 30

1 Project Summary: The FDA is currently lacking in standardized methods for ante mortem (live 2 animal) and post mortem analysis of animal diagnostic specimens potentially associated with 3 animal food/feed contamination events. To address this gap, existing FDA methodologies must 4 be extended to testing of new matrices such as milk, urine, blood, and tissues. The purpose of 5 this project is to validate analytical methods for determination of trace (macro and micro) 6 element, heavy metal, and rare earth element contamination in animal diagnostic samples. A 7 survey conducted in 2011-2012 revealed over 50 contamination events nationwide attributed to 8 trace elements and heavy metals such as copper, sulfur, lead, arsenic, zinc, selenium and 9 phosphorus. Furthermore, animal feed recalls by FDA from 2009-2012 have included 10 contamination events from zinc, potassium, copper, and molybdenum. Lastly, rare earth 11 elements have proved useful for tracing suspicious shipments of food/feed back to specific 12 manufacturers, suppliers, and geographical regions. The consortium of veterinary diagnostic 13 laboratories from Washington, Idaho, Wyoming, and Utah included in this proposal have 14 extensive experience animal contamination events associated with the long established mineral 15 mining industry in the western United States. All laboratories will use established microwave 16 digestion and Inductively Coupled Plasma Mass Spectrometer (ICP-MS) methods. Following 17 FDA guidelines, the lead laboratory (Washington Animal Disease Diagnostic Laboratory- 18 Analytical Sciences Laboratory) will generate homogeneous and stable test materials in animal 19 feed, animal tissues (liver, kidney, brain), blood, milk and urine over the course of the study (4 20 years) for macroelements, microelements, heavy metals, and rare earth elements. For each 21 analyte method, performance criteria will be documented for accuracy, precision, selectivity, 22 limit of detection, limit of quantification, linearity, range, measurement uncertainty and 23 ruggedness. Consortium laboratories in Wyoming and Utah will use standardize methods 24 developed during the project to analyze samples as blinded unknowns to determine 25 reproducibility and repeatability. Final data will be analyzed using AOAC 2002 guidelines for 26 validation of chemical methods and final results communicated throughout the Vet-LIRN. The 27 results of the cooperative agreement will increase the suite of validated methods needed for 28 animal diagnostic specimens in order to increase the capacity and capability of FDA to respond 29 to animal food/feed contamination events. 30