PDF(Pubmed)
Abstract：
Testing accuracy of a chemical contaminant requires use of a testing platform that conforms to validation criteria outlined in quality literature and standards. This study explores the application of commercial field data measured by qualified analysts using a United States Department of Agriculture - Federal Grain Inspection Service approved kit for measuring fumonisin in maize to augment method validation procedures. Analysts from seven grain testing facilities were qualified in official USDA sampling, sample preparation, and testing methodology using the Charm LF-FUMQ-WETS5. A duplicate sample was tested in the Office of the Texas State Chemist (OTSC) laboratory using UPLC-MS-MS. Data were subject to four statistical techniques using continuous and categorical methodology. This approach enabled researchers to explore if a single test or multiple comparisons were best suited to assess a field kit\'s fitness for purpose across facility, toxin level, and year. The study concluded that a paired t-test and correlation analysis provided a quick and meaningful evaluation of kit performance. The correct placement of samples within the correct bin (violative versus non-violative) aligns well with market forces and regulatory compliance. The results of this study also provide a useful tool to assess all field kits\' performance at the beginning of the harvest season and subsequent years. The combination of statistical techniques presented in this research is an important tool in assessing mycotoxin field test kits fitness for purpose and represents a key step in a continuous improvement-quality systems process meant to protect the feed and food supply.
摘要：
测试化学污染物的准确性需要使用符合质量文献和标准中概述的验证标准的测试平台。这项研究探讨了由合格的分析师使用美国农业部-联邦谷物检验局批准的用于测量玉米中伏马菌素的试剂盒测量的商业现场数据的应用，以增强方法验证程序。来自七个谷物检测机构的分析师在美国农业部的官方抽样中获得了资格，样品制备,以及使用CharmLF-FUMQ-WETS5的测试方法。使用UPLC-MS-MS在德克萨斯州化学家办公室（OTSC）实验室测试了重复样品。使用连续和分类方法对数据进行了四种统计技术。这种方法使研究人员能够探索单个测试或多个比较是否最适合评估现场套件在整个设施中的适用性。毒素水平，和年份。研究得出的结论是，配对t检验和相关性分析可对套件性能进行快速而有意义的评估。样品在正确的箱中的正确放置(违规与非违规)与市场力量和法规遵从性很好地一致。这项研究的结果也提供了一个有用的工具来评估所有田间试剂盒在收获季节和随后几年的性能。本研究中提出的统计技术的组合是评估霉菌毒素现场测试套件适用性的重要工具，并且代表了旨在保护饲料和食品供应的持续改进质量系统过程中的关键步骤。
