肌酐在不同检测系统间的测量不确定度和可比性研究  

The study of measurement uncertainty and traceability on the results of different detecting system in creatinine assay

作　　者：李有强[1,2] 张云燕 陈茶[1] 张轩[1] 曾建明[1] 刘健平[1] 徐建华[1] 

机构地区：[1]广东省中医院检验医学部,广州510006 [2]广州中医药大学第二临床医学院,广州510405 [3]广东省广州市妇女儿童医疗中心口腔科,501180

出　　处：《重庆医学》2015年第17期2398-2400,共3页Chongqing medicine

基　　金：国家中医药行业专项(201007005);广东省中医院拔尖人才项目(2014-47);广州中医药大学优秀青年基金项目(KAB111133K02)

摘　　要：目的评定不同检测系统间肌酐测定结果的测量不确定度和量值溯源,探讨不同检测系统肌酐测定结果的可比性,为实验室检验结果互认和实验室认可提供实验数据。方法以国家有证参考物质作为"正确性质控物",参考NATA颁布的"化学测量结果不确定度评定与报告导则",对不同检测系统肌酐测定结果的测量不确定度进行评定,将结果溯源至国家有证参考物质。根据CLSI的EP9-A2文件,对不同检测系统肌酐测定结果进行偏差评估和比对分析,以检测系统偏倚的不确定度(Ub)作为判断依据,将t(0.05,ν)Ub作为临床可接受的判断标准,评定肌酐在不同检测系统测定结果的可比性。结果 3个检测系统测定肌酐国家参考物质所测均值均不同,检测系统A、B和C分别为61.72mol/L、62.59mol/L和61.54mol/L。3个检测系统间的偏倚差异均无统计学意义(P>0.05);3个检测系统肌酐测定结果的扩展不确定度亦不相同,但均在卫生部临床检验中心室间质评规定的最大允许范围之内。3个检测系统用新鲜血清标本进行两两比较显示测定结果间差异无统计学意义(P>0.05),结果具有可比性。结论肌酐在不同检测系统进行检验结果的互认时,应测定各检测系统的测量不确定度和量值溯源,并对不同检测系统间测定结果进行偏差评估,判断其临床可接受性,以保证检验结果的准确性和可比性。Objective To study the measurement uncertainty and traceability of creatinine assay and study the comparability of results among three different detection systems.Methods Three different detecting systems were used to detect creatinine concentration using the national certified reference material as ＂quality control substance＂.The measurement uncertainty of the results was evaluated referring ＂ Guidelines for estimating and reporting measurement uncertainty of chemical test results＂ of NATA.The results were traced back to national certified reference material.According to the CLSI document EP9-A2,the results were analyzed by bias estimation with the t（0.05,ν）Ub as the clinical criterions,and investigated the comparability in different detecting systems.Results The means measured by three creatinine assay systems were 61.72mol/L,62.59mol/L and 61.54mol/L,respectively.The bias in the three detection systems did not have statistical significance（P〉0.05）.The expanded uncertainty of three detection systems was different,but the difference was within the maximum acceptable range of the external quality assessment from National Center for Clinical Laboratory.There was not statistical significant difference among the three systems（P〉0.05）used fresh clinical specimen in comparing system bias.Conclusion It is necessary to estimate the uncertainty and traceability when comparing the creatinine concentration among different detection system.It also needs to estimate the bias of different systems and evaluate the clinical acceptability to ensure the accuracy and comparability of results.

关 键 词：肌酸酐 测量不确定度 量值溯源 实验室技术和方法 

分 类 号：R446.1[医药卫生—诊断学]