自建和配套生化检测系统血清酶测定结果的偏差评估和可比性分析  

The comparability study and the bias evaluation on the result of serum enzymes with self-developed and matching biochemical detecting systems

作　　者：沙瑶[1] 石凌波[1] 康红[1] 孙宏华[1] 谢进进[1] 胡远明[1] 王露霞[2] 史慧群 

机构地区：[1]广州中医药大学祈福医院检验科,广东广州511495 [2]广州军区广州总医院检验科,广东广州510010 [3]广州市越秀区第二人民医院检验科,广东广州510180

出　　处：《检验医学》2010年第9期697-700,共4页Laboratory Medicine

基　　金：广州市番禺区科技局基金资助(2007-Z-74-1)

摘　　要：目的通过对自建和配套生化检测系统血清酶测定进行方法比对和偏差评估,探讨2种检测系统间血清酶测定结果的一致性。方法按照美国临床实验室标准化委员会(NCCLS)EP9-A2文件的要求,以奥林巴斯AU400生化分析仪、奥林巴斯原装试剂、奥林巴斯原装校准品组成的配套检测系统为目标检测系统,以奥林巴斯AU400生化分析仪、国产试剂、罗氏cfas校准品组成的自建检测系统为试验检测系统,用患者新鲜血清对丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、γ-谷氨酰基转移酶(GGT)、碱性磷酸酶(ALP)、乳酸脱氢酶(LDH)和肌酸激酶(CK)进行检测,对2种检测系统之间的预期偏差进行评估。当预期偏差不能接受时,对新鲜混合血清赋值后重新用新的校准值校准自建检测系统。结果在检测的6个项目中,除AST外,其余项目测定结果的偏差均能接受。AST经重新赋值后,2种检测系统的偏差减小,结果可以接受。结论校准和校准验证是实现自建检测系统量值溯源性和可比性的有效途径,通过新鲜血清对日常校准品重新赋值,可达到自建和配套检测系统检测结果的一致性。Objective To study the coincidence of serum enzyme results of self-developed and matching biochemical detecting systems through the method comparison and bias evaluation.Methods According to National Committee for Clinical Laboratory Standards（NCCLS） document EP9-A2,OLYMPUS AU400 biochemical analyzer,original reagent and its calibrator were performed as the detecting system,and OLYMPUS AU400 biochemical analyzer,homemade reagent and Roche cfas calibrator were the self-developed detecting system.6 serum enzyme items including alanine aminotransferase（ALT）,aspartate aminotransferase（AST）,gamma-glutamyltransferase（GGT）,alkaline phosphatase（ALP）,lactate dehydrogenase（LDH） and creatine kinase（CK） were determined,and the results were used to analyze the prospective bias between these two systems.When the bias was not acceptable,a fresh mixed serum was assayed in OLYMPUS AU400 reagent testing system,and the result was adopted as temporary calibrator to calibrate self-developed detecting system.Results The system bias of AST was not acceptable,and the other 5 items could be accepted.After the value of temporary calibrator was determined and used,the bias between the two systems was significantly decreased and acceptable.Conclusions The traceability and comparability of self-developed detecting system can be achieved by calibration and verification.The value of calibrator can be determined using fresh mixed serum for the coincidence of different biochemical detecting systems.

关 键 词：酶 方法比对 偏差 评估 新鲜血清 

分 类 号：Q55[生物学—生物化学]