摘要
目的:评价室间质量评价(EQA)样品在总蛋白(TP)双缩脲终点法单试剂盒和双试剂盒间的互通性。方法:参照卫生行业标准WS/T 356-2011进行互通性研究。将同一厂家生产的TP双缩脲终点法单试剂盒和双试剂盒分别与同一台日立7600全自动生化分析仪组成检测系统,以双试剂盒所组成的检测系统为比对方法、单试剂盒所组成的检测系统为待评方法,分别同时测定40人份新鲜血清样品和5份常规生化EQA样品,评价EQA样品在两试剂盒间的互通性。结果:回归方程为Y=1.0102 X-0.0867,相关系数r为0.9984,两试剂盒间检测结果的相关性良好;但5份EQA样品的检测结果均超过Y预测值95%置信区间上限,存在明显的正基质效应,其互通性相关偏倚为7.12%~11.28%。结论:EQA样品在两试剂盒间缺乏互通性。EQA时两试剂盒不能归为同一组内,需独立分组计算靶值,否则,将引起EQA结果解释错误。
Objective:To evaluate the commutability between the single kit and the double kit of the total protein(TP)biuret endpoint method for the external quality assessment(EQA)samples.Methods:According to the health industry standard WS/T 356-2011,the single kit and the double kit produced by the same manufacturer and the same Hitachi 7600 automatic biochemical analyzer are respectively combined into a detection system,with the double kit detection system as the comparison method and the single kit detection system as the method to be evaluated.40 fresh serum samples and 5 routine biochemical EQA samples were measured simultaneously to evaluate the commutability of EQA samples between the two kits.Results:The regression equation was Y=1.0102 X-0.0867,and the correlation coefficientr was 0.9984.there was a good correlation between the detection results of the two kits.However,the detection results of the five EQA samples all exceeded the upper limit of 95%confidence interval of the Y predicted value,and there was a significant positive matrix effect,and the correlation bias of commutability was 7.12%~11.28%.Conclusion:The EQA sample lacks commutability between the two kits.In EQA,the two kits cannot be grouped into the same group,and the target value should be calculated in groups,otherwise,the result of EQA will be interpreted incorrectly.
作者
李祥坤
肖光军
杨娜
刘艳婷
赵思涵
LI Xiangkun;XIAO Guangjun;YANG Na;LIU Yanting;ZHAO Sihan(Suining Central Hospital,Suining 629000,China)
出处
《临床医药实践》
2020年第3期212-214,219,共4页
Proceeding of Clinical Medicine
关键词
基质效应
互通性
室间质量评价
总蛋白
matrix effect
commutability
external quality assessment
total protein
作者简介
李祥坤(1977—),男,四川省遂宁市射洪县人,副主任技师,主要从事临床实验室质量控制工作;通信作者:肖光军。
