NordVal食品微生物定性分析方法的验证程序

Confirmation process of NordVal microbial qualitative analysis method

中文关键词:  NordVal  微生物  定性方法  方法比较研究  协同研究

英文关键词:NordVal  microbiology  qualitative method  method comparison  collaborative study

中文摘要:

      目的 为了在微生物研究过程乃至日常检测工作中, 将国际标准的要求融入到每个检测过程中, 根据NordVal对申请为标准的微生物学定性分析方法的验证程序进行了整理和总结。方法 定性方法验证包括两个方面: 比较研究和协同研究。方法验证负责人应首先根据要求制定方法确认的技术方案, 先进行试验内比较研究实验, 然后, 由协作实验室用相同的样品进行实验室间协同实验。采用待确认的方法与基准方法进行比较研究的方式, 对方法的性能指标进行确认。结果 定性分析方法验证程序的性能指标主要包括: 灵敏度、特异性、相对精度、相对检测水平、方法的一致性。待确认方法与基准方法比较时, 定性方法应达到以下性能指标: 灵敏度≥95%; 特异性≥95%; 替代方法的检测限应与基准方法的检测限一致; 方法的一致性值>0.8。结论 本文将为标准方法的制修订、实验室方法的确认提供规范的依据。

英文摘要:

      Objective In order to apply the international standards to each detection process in microbiological research process and daily inspection work, the NordVal analysis method to apply for the standard mi-crobiology qualitative validation procedures were collated and summarized. Methods The qualitative method validation of NordVal included two aspects: the comparative study and collaborative study. The technical scheme of the method validation responsible person should first make the method validation, test in comparative experiments, then, by collaborating laboratories with the same samples for laboratory collaborative experiment. The performance index of the confirmation method were confirmed by the comparison of the method to be confirmed and the baseline methodology. Results The performance index about validation of qualitative method included: procedures sensitivity, specificity, accuracy, the relative level of detection and the relative consistency of the method. Compared to the confirmation method and the reference method, qualitative method met the following performance metrics: the rate of sensitivity and specificity was more than 95%. The detection of alternative method detection limits should be consistent with the reference method for the limit and the value of consistency should be more than 0.8. Conclusion This paper will provide a standardized basis for the formulation and revision of standard methods and the confirmation of laboratory method.