CAJ | 학술논문

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。
목적：위료재미생물연구과정내지일상검측공작중，장국제표준적요구융입도매개검측과정중，근거NordVal대신청위표준적미생물학정성분석방법적험증정서진행료정리화총결。방법정성방법험증포괄량개방면：비교연구화협동연구。방법험증부책인응수선근거요구제정방법학인적기술방안，선진행시험내비교연구실험，연후，유협작실험실용상동적양품진행실험실간협동실험。채용대학인적방법여기준방법진행비교연구적방식，대방법적성능지표진행학인。결과정성분석방법험증정서적성능지표주요포괄：령민도、특이성、상대정도、상대검측수평、방법적일치성。대학인방법여기준방법비교시，정성방법응체도이하성능지표：령민도≥95%；특이성≥95%；체대방법적검측한응여기준방법적검측한일치；방법적일치성치>0.8。결론본문장위표준방법적제수정、실험실방법적학인제공규범적의거。
ABSTRACT:ObjectiveIn 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 microbiology 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. ConclusionThis paper will provide a standardized basis for the formulation and revision of standard methods and the confirmation of laboratory method.