临床肌酐检测结果质量水平现状分析及溯源性问题研究  

Analysis of Current Clinical Creatinine Testing Quality and the Study of Their Traceability

作　　者：王薇[1] 张建平[2] 王治国[1] 钟堃[1] 白玉[1] 

机构地区：[1]卫生部北京医院卫生部临床检验中心,北京100730 [2]北京朝阳医院检验科,北京100020

出　　处：《现代检验医学杂志》2011年第3期47-50,共4页Journal of Modern Laboratory Medicine

摘　　要：目的针对目前不同的检测方法和不同的检测系统检测肌酐的结果存在较大差异，期望通过不同的组织机构之间进行合作，将肌酐的检测结果溯源到参考物质和参考测量程序，实现肌酐检测的准确性。方法对卫生部临床检验中心2009年组织的常规化学室间质量评价中肌酐检测结果数据，2008年美国病理学家学会（CAP）调查肌酐检测结果数据，以及北京地区30家医院检验科生化室参加国际测量评估计划-17（IMEP-17）的数据进行统计分析。结果全国2009年第三次肌酐血清检测按照方法分组统计的结果：五个批号苦味酸方法比酶法检测的变异系数高，浓度范围为99-344umol／L，变异系数的范围为3．92％～8．01％。按检测系统分组，Vitros 250 chem System，Becksyn Chron LX20，Dade Behrg DIM的变异系数分别为：3．61％～5．23％，3．69％～7．91％和2．72％～7．42％。2008年美国CAP Vitros 250 chem System，Becksyn Chron LX20和Dade Behrg DIM的变异系数分舅q为：3．5％～5．9％，1．4％～6．4％和2．1％～9．8％。在北京30家实验室参加新鲜冰冻血清、用参考方法定靶值的室同比对计划中，肌酐检测结果的差异较大，最小值为66umol／L，最大值为105．3umol／L；检测偏倚的变化范围为2．19％～41．21％。按照肌酐的可接受范围为（74．57±11．18）umol／L，在这30家生化实验室里只有11家满足要求。结论应该将肌酐的检测方法溯源到液相色谱一同位素稀释质谱法（LC—IDMS）。Objective Because of the significant variation between the results of creatinine of different test methods and different test systems,intend to trace the results to reference materials and reference test methods for the accuracy of creatinine tests by the cooperation with different institutions. Methods By statistics analysis the results of creatinine of institutions which attended the EQA common biochemistry program of CNCCL in 2009,the survey of CAP creatinine tests results and the clinical laboratories in 30 hospitals in Beijing which attended IMEP-17,completed this study. Results The results of the third time serum creatinine test of CNCCL EQA program were divided into groups for different methods：the CVs of the results of picric acid method was higher than the enzymatic method in the five lots,the range of concentration was 99- 344 umol/L and the range of CVs was 3.92%-8.01%. After grouped by testing systems ,the CVs ranges of Vitros 250 chem System ,Becksyn Chron LX20 and Dade Behrg DIM were 3. 61%- 5.23%, 3.69%- 7.91 % and 2.72%- 7.42% respectively. The CVs of US 2008 CAP study of creatinine testing of Vitros 250 chem System ,Becksyn Chron LX20 and Dade Behrg DIM were 3.5%- 5.9%, 1.4% - 6.4% and 2.1 %- 9.8% respectively. In the 30 Beijing laboratories which attended the reference methods target value eternal comparison program by using fresh frozen serum,the differences of creatinine tests results were remarkable while the minimum value was 66 umol/L and the maximum value was 105. 3 umol/L. The range of test bias variation is 2.19%- 41.21%. According to the acceptable range of creatinine which was （74.57±11.18）umol/L,only 11 of the 30 institutions cound fulfill the application. Conclusion The methods of creatinine testing all need to be traced to LC-IDMS.

关 键 词：慢性肾病 肾小球滤过率 肌酐 准确性 溯源性 

分 类 号：R446.112[医药卫生—诊断学]