血清总胆红素测量原理与测量结果正确度的相关性研究  

Research on the Correlation Between Measuring Principles and the Measurement Result Accuracy of Total Bilirubin in Serum

作　　者：邵燕[1] 刘淑明[1] 孙慧颖[1] 胡滨[1] 陈宝荣[1] SHAO Yan LIU Shu-ming SUN Hui-ying HU Bin CHEN Bao-rong(Beijing Aerospace General Hospital Clinical Laboratory ,Beijing 10007 ,China)

机构地区：[1]北京航天总医院,北京100076

出　　处：《标记免疫分析与临床》2017年第9期1052-1055,共4页Labeled Immunoassays and Clinical Medicine

基　　金：首都卫生发展科研专项(首发2011-6032-02)

摘　　要：目的研究国内临床实验室常用血清总胆红素(T-Bil)测量原理与测量结果正确度的相关性。方法优选11个国内外厂家13种T-Bil试剂盒,涉及矾酸盐氧化法(5/13)、重氮法(3/13)、化学氧化法(3/13)、酶法(2/13)4种测量原理,复现13种厂家配套系统,分别测量冰冻人血清基质T-Bil国家一级标准物质GBW09184和GBW09185 3次,计算各系统和相同测量原理的各系统测量平均值,绘制测量结果 Youden图,依据WS/T 403-2012卫生行业标准判断测量结果的正确度。结果 (1)13种T-Bil厂家配套系统测量标准物质GBW09184和GBW09185的结果与标准物质认定值的偏移分别为:-6.07%、6.2 3%、5.30%、1.39%、-9.22%、9.22%、7.68%、16.74%、-4.69%、-5.61%、-12.18%、0.63%、6.58%;-5.68%、4.78%、5.46%、2.32%、-8.37%、10.01%、9.27%、17.26%、-5.53%、-4.78%、-14.2%、1.19%、9.99%。采用卫生行业标准判断只有15%(2/13)T-Bil厂家配套系统的测量结果能满足量值溯源要求。(2)矾酸盐氧化法、重氮法、化学氧化法和酶法4种测量原理厂家配套系统测量标准物质GBW09184和GBW09185的结果与标准物质认定值的平均偏移分别为:2.96%、6.94%、-2.78%、-5.74%;3.59%、6.73%、-0.90%、-6.50%。矾酸盐氧化法和化学氧化法测量原理的各系统测量结果均值能满足量值溯源要求。结论 (1)目前国内市场血清T-Bil厂家配套系统测量结果的正确度不容乐观,实验室在建立、更新T-Bil常规测量系统前应进行正确度评价。(2)T-Bil测量结果正确度与测量原理不存在因果关系。Objective To research the correlation between commonly used measuring principles and the measurement result accuracy of total bilirubin in serum in domestic clinical laboratories.Methods Pre-selected 13 kinds of T-Bil reagent kits from 11 domestic and foreign manufacturers, referring to 4 kinds of commonly used measuring principles involving vitriol acid salt oxidation method （5/13）, diazo method （3/13）, chemical oxidation method （3/13）, enzyme method （2/13） and reproduce 13 kinds of T-Bil factory matching systems.We measured T-Bil with national primary standard materials GBW09184 and GBW09185 in frozen human serum matrix 3 times respectively, then calculated the measurement result means of every measurement system and the ones having the same measuring principle, respectively.

关 键 词：总胆红素 常规系统 正确度 溯源 标准物质 

分 类 号：R446.1[医药卫生—诊断学]