CAJ | 학술논문

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。
목적：탐토상동실험실불동검측계통간6충상용혈청매활성측정결과시부구유가비성，위실현혈청매측정적소원성화가비성제공의거。방법이일립-008전자동생화분석의급라씨원장시제、교준품、질공품등조성적검측계통위삼비계통즉비교방법（X），이 ABBOTT ARCHITECT C16000전자동생화분석의급검측시제、교준품、질공품등조성적계통위검측계통즉실험방법（Y ），근거미국림상실험실표준화위원회（NCCLS）EP9-A2문건，측정환자신선혈청중병안산안기전이매（ALT）、천문동안산안기전이매（AST）、감성린산매（ALP）、γ-곡안선전태매（GGT）、유산탈경매（LDH）화기산격매（CK）공6충매적준학도화정밀도，대Y 화 X 량법적매활성결과진행비교병계산기상대편차（SE％），이미국림상실험실수정법규（CLIA′88）규정적실간질량평개윤허오차범위적1/2위표준，판단불동계통측정결과시부구유가비성。결과일립-008화 ABBOTT ARCHITECT C16000전자동생화분석의측정 ALT、AST、ALP、GGT、LDH、CK 6충혈청매활성결과적준학도화정밀도균부합요구，계통오차림상가이접수。결론당용량개급이상적검측계통검측동일검험항목시，응진행방법비대화편의평고，판단림상가접수성，이보증검험결과적준학성화가비성。
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.