日立-008和雅培ARCHITECT C16000生化分析仪检测6种血清酶结果比对分析

Comparative analysis on results of 6 serum enzymes detected by Hitachi 008 and ARCHITECT C16000 biochemical analyzers

目的探讨相同实验室不同检测系统间6种常用血清酶活性测定结果是否具有可比性,为实现血清酶测定的溯源性和可比性提供依据。方法以日立-008全自动生化分析仪及罗氏原装试剂、校准品、质控品等组成的检测系统为参比系统即比较方法(X),以ABBOTT ARCHITECT C16000全自动生化分析仪及检测试剂、校准品、质控品等组成的系统为检测系统即实验方法(Y),根据美国临床实验室标准化委员会(NCCLS)EP9-A2文件,测定患者新鲜血清中丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、碱性磷酸酶(ALP)、γ-谷氨酰转肽酶(GGT)、乳酸脱氢酶(LDH)和肌酸激酶(CK)共6种酶的准确度和精密度,对Y和X两法的酶活性结果进行比较并计算其相对偏差(SE%),以美国临床实验室修正法规(CLIA′88)规定的室间质量评价允许误差范围的1/2为标准,判断不同系统测定结果是否具有可比性。结果日立-008和ABBOTT ARCHITECT C16000全自动生化分析仪测定ALT、AST、ALP、GGT、LDH、CK 6种血清酶活性结果的准确度和精密度均符合要求,系统误差临床可以接受。结论当用两个及以上的检测系统检测同一检验项目时,应进行方法比对和偏倚评估,判断临床可接受性,以保证检验结果的准确性和可比性。

Objective To investigate the comparability of the activity detection of 6 common serum enzymes by different bio-chemical detecting systems at the same laboratory to provide the basis for realizing the traceability and comparability of serum en-zyme detection.Methods The detection system consisted of the Hitachi 008 biochemical analyzer,and original reagents,C-fas cali-brator and controller of Roche was taken as the reference system X（comparison method）and the detection system consisted of the ABBOTT ARCHITECT C16000 biochemical analyzer,reagents and calibrator of Zhongsheng,and controller of BIO-RAD was taken as the detecting systemY （laboratory method）,which were used to detect the accuracy and precision of fresh serum enzymes inclu-ding ALT,AST,ALP,GGT,LDH and CK according to the NCCLS document EP9-A2.Then the enzyme activity results detected by the Y and X methods were compared and the relative error（SE%）was calculated.The comparability of the results detected by these two kinds of different detection systems was judged with 1/2 of allowable error in the external quality assessment stipulated by CLIA′88 as the standard.Results The accuracy and precision of the activity detection results of 6 enzymes by the Hitachi 008 and ARCHITECT C16000 biochemical analyzers all conformed to the requirements and the systematic error was clinically acceptable. Conclusion In measuring same test item by two or more detection systems,the method comparability and the bias assessment should be performed for ensuring the accuracy and comparability of the detection results.