文章摘要
张咪,张文新,于婷,李丽莉,黄杰.以肌酐冰冻人血清国家标准物质为例探索生化免疫类体外诊断试剂标准物质的研制[J].中国药事,2024,38(1):45-52
以肌酐冰冻人血清国家标准物质为例探索生化免疫类体外诊断试剂标准物质的研制
Exploring the Development of Reference Materials for Biochemical andImmunological in vitro Diagnostic Reagents by Taking the Human CreatinineSerum Reference Material as the Representative
投稿时间:2023-11-20  
DOI:10.16153/j.1002-7777.2024.01.006
中文关键词: 同位素稀释液相串联质谱  肌氨酸氧化酶法  量值溯源  标准物质  基质效应
英文关键词: isotope dilution liquid phase tandem mass spectrometry  sarcosine oxidase  metrological traceability  standard reference material  matrix eff ect
基金项目:
作者单位
张咪 中国食品药品检定研究院国家药品监督管理局体外诊断试剂质量研究与评价重点实验室北京 100050 
张文新 中国食品药品检定研究院国家药品监督管理局体外诊断试剂质量研究与评价重点实验室北京 100050 
于婷 中国食品药品检定研究院国家药品监督管理局体外诊断试剂质量研究与评价重点实验室北京 100050 
李丽莉 中国食品药品检定研究院国家药品监督管理局体外诊断试剂质量研究与评价重点实验室北京 100050 
黄杰 中国食品药品检定研究院国家药品监督管理局体外诊断试剂质量研究与评价重点实验室北京 100050 
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中文摘要:
      目的:根据临床参考体系中生化免疫类标准物质的研制现状,选取具有重要临床意义的代表性标准物质进行评价,探索现阶段研制中潜在的问题,并根据结果进行研制路径优化的讨论,更好地完善检验参考系统标准化建设。方法:选取肌酐标准物质作为代表,参照美国临床实验室和标准化协会发布的EP14-A3及中华人民共和国卫生部发布的WS/T 356-2011相关要求设置评价方案,对国内2个不同机构研制的4个血清肌酐国家标准物质及21份人新鲜血清样本,按照方案进行同位素稀释质谱参考方法及肌氨酸氧化酶法常规方法检测。对检测结果进行处理后,对国家标准物质进行准确性、基质效应及互通性指标评价。结果:检测结果显示,准确性、基质效应及互通性指标结果各异,有3个标准物质的参考方法测量结果不在其标示靶值±不确定度范围,且有GBW09170和GBW09171测量结果偏差在常规检测方法中加大的情况,其中GBW09171出现基质效应。结论:生化免疫类标准物质在研制过程中应充分考虑临床适用性,针对采用参考方法研制的标准物质,如本次评价的肌酐标准物质,应注意不同参考方法、不同实验室运行及不同方法学的差异,考虑采用多家或不同原理方法学联合定值,充分考察标准物质在不同方法学间的互通性,保证这类物质量值的准确传递,优化标准物质的研制路径,助力精准医学。
英文摘要:
      Objective: To explore potential problems in current reference materials development by selectingone representative with important clinical signifi cance for evaluation, and to discuss the optimization of producedpath according to the results to better improve the standardization of inspection reference system, based on thestatus of biochemical and immunological standard reference materials in the clinical reference system. Methods:According to the standards of EP14-A3 of the Clinical and Laboratory Standards Institute and WS/T 356-2011 of the National Center for Clinical Laboratories, the evaluation scheme was set up. 4 creatinine in frozen humanserum reference materials produced by reference methods from two diff erent domestic organizations and 21 freshhuman serum samples, were tested by reference methods of isotope dilution mass spectrometry and conventionalmethods of sarcosine oxidase according to the scheme. After processing the test results, the accuracy, matrixeff ects and commutability of the reference materials were studied. Results: The result of 4 reference materials and21 fresh human serum samples displayed diff erence in accuracy and matrix eff ect including reference methods andconventional methods. Three reference materials cannot ensure that the results within the range of target value ±uncertainty from reference methods, the deviation of GBW09170 and GBW09171 increased in the conventionalmethods, GBW09171 also showed matrix eff ects. Conclusion: Clinical applicability should be fully consideredin the development process of biochemical and immunological standard reference materials. When referencemethods are used to produce biochemical and immunological reference materials, such as creatinine in thisevaluation, attention should be paid to the diff erence of diff erent reference methods, and joint assignments shouldbe considered. At the same time, the commutability among diff erent methods should be fully considered to ensurethe accurate transfer of quantitative values as for optimization of produced path, supporting precision medicine.
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