不同检测系统HBDH测定结果的可比性研究  

Study on the comparability of measured HBDH results with different biochemical detecton systems

作　　者：吴子安[1] 卓兰云[2] 徐宁[1] 黄宪章[3] 张秀明[2] 梁伟雄[4] 

机构地区：[1]广东省中医院芳村分院检验科,广东广州510370 [2]广东省中医院检验科,广东广州510370 [3]广东省中医院二沙分院检验科,广东广州510370 [4]广东省中医院科研部,广东广州510370

出　　处：《医疗设备信息》2007年第1期8-10,共3页Information of Medical Equipment

基　　金：国家高技术研究发展计划(863计划)课题资助(2002AA2Z341B)

摘　　要：目的通过对同一临床实验室不同检测系统进行方法比对和偏差评估，探讨不同检测系统间α羟丁酸脱氢酶（HBDH）测定结果是否具有可比性，为血清酶测定的标准化提供实验数据。方法参考NCCLS的EP9-A文件，以日立7170生化分析仪、罗氏原装试剂、c．f．a．s校准品和质控品组成的检测系统3（已通过ISO／IEC17025标准认可）为比较方法，检测系统1～2为实验方法，用患者新鲜血清对HBDH进行检测，计算实验方法（Y）和比较方法（X）之间的相对偏差（％SE），以CLIA‘88规定的室间质量评价允许误差范围的1／2为标准，判断不同检测系统的可比性。结果HBDH测定结果各系统的误差临床均可以接受。结论各检测系统测定HBDH结果具有可比性。当同一实验室同一检验项目存在二个以上的检测系统时，应进行方法比对和偏差评估，以保证检验结果的可比性。Objective To explore the comparability of α- hydroxybutyrate dehydrogenase （HBDH） results of different biochemical detection systems. Method Refering to EP9- A file of NCCLS, different biochemical detection systems, detecting system 1 -2（laboratory method） and detection system 3 （target system ： comparison method, which includes Hitachi 7170 biochemical analyzer, reagent of Roche, c. f. a.s. calibrator and controller of Roche approved by ISO/IEC 17025）, were used to 2 serum enzyme items such as HBDH to obtain the correlation coefficient and linear equation respectively, Then the coefficient and equation were used to evaluate the system bias between laboratory method and comparison method. The comparability of different investigate systems was judged according to the half of CLIA＇ 88 standard. Results The system bias of HBDH could be accepted between several investigate systems and target system. Conclusion The comparability of HBDH results in 3 kinds of detection system accorded to the evaluation of clinical acceptability. If there are more than two systems for the same test, it is necessary to do method comparison and Bias estimation in order to einsure the comparability.

关 键 词：α羟丁酸脱氢酶 比对试验 生化分析仪 

分 类 号：R331[医药卫生—人体生理学] TH776[医药卫生—基础医学]