双水平校准纠正苦味酸法肌酐检测偏移  

Correcting bias of creatinine testing using Jaffe assay by double-levels calibration

作　　者：牛长春 万雅芳 李甜 廖璞[1] 

机构地区：[1]重庆市人民医院三院院区检验科/重庆市临床检验中心,重庆400014

出　　处：《临床检验杂志》2017年第9期654-656,共3页Chinese Journal of Clinical Laboratory Science

基　　金：重庆市卫生和计划生育委员会重点项目(2015ZDXM023);重庆市科学委员会项目(cstc2016jcyja0177)

摘　　要：目的通过临床检验实验室间质量评价(室间质评)分析苦味酸法检测肌酐的偏移及校准对偏移的影响。方法利用重庆市临床检验室间质评数据,开展冰冻混合人源血清(参考方法赋值)调查,分析苦味酸法与酶法肌酐检测结果间的差异及偏移;用双浓度水平冰冻混合人源血清(参考方法赋值)校准常规检测系统后检测室间质控品。结果 2012年至2016年重庆市苦味酸法肌酐检测实验室数下降;苦味酸法实验室稳健均值与酶法存在差异,且差值与肌酐水平有相关性(r=0.774 6);冰冻混合人源血清(参考方法赋值)调查及国家卫计委临床检验中心正确度验证结果均显示,苦味酸法肌酐在低浓度存在正偏移(最大达10.39%和13.31%),且偏移与浓度相关(r=0.988 9),而酶法肌酐的偏移较小(最大达1.04%和1.49%);用冰冻混合人源血清校准常规检测系统后,苦味酸法肌酐检测在低浓度的正偏移被抵消。结论苦味酸法肌酐检测在低值范围存在正偏移,双浓度水平校准可纠正此偏移。Objective To evaluate the bias of creatinine testing by external quality assessment （EQA） and analyze the effects of calibration on the bias of tested values using Jaffe assay.Methods The EQA data from The Clinical Laboratory Centre of Chongqing City were utilized to investigate the frozen pooled-human serum in which the value of creatinine was determined by reference method.The differences between Jaffe assay and creatine oxidase method were analyzed and the bias was evaluated.After the routine measurement systems were calibrated using the frozen pooled-human sera with double levels,the EQA samples were tested.Results The number of the laboratories using Jaffe method for creatinine measurement reduced significantly in Chongqing from 2012 to 2016.The robust average values of Jaffe assay were different from enzymatic assay significantly and the difference of the values were correlated with the concentration of creatinine （r = 0.774 6）.The results of the investigation using frozen pooled human serum and the trueness verification program of National Center for Clinical Laboratories indicated the positive bias of Jaffe assay was observed in low levels of creatinine with maximum of 10.39% and 13.31% and the bias correlated with the concentration of creatinine （r = 0.988 9）,by contrast the bias was low in enzymatic assay with maximum of 1.04% and 1.49% only.After the measurement systems were calibrated by frozen pooled human sera with double-levels,the positive bias of Jaffe assay in the low concentration of creatinine could be corrected.Conclusion There may be a positive bias of Jaffe assay for the samples with low concentration of creatinine,which could be corrected by using the calibrators with double-levels.

关 键 词：校准 双浓度水平 肌酐 室间质量评价 

分 类 号：R446[医药卫生—诊断学]