不同仪器间常规生化项目测定比对分析和偏倚评估  

Contrast and bias estimation on result of routine biochemistry items in different biochemical analyzers

作　　者：齐永志[1] 马聪[1] 赵强元[1] 刘敏[1] 

机构地区：[1]海军总医院检验科,北京100048

出　　处：《医疗卫生装备》2014年第7期92-94,共3页Chinese Medical Equipment Journal

摘　　要：目的:对3台全自动生化分析仪14个项目的测定结果进行比对分析和偏倚评估,探讨实验室不同仪器间测定结果在允许范围内是否具有可比性。方法:参照美国国家临床实验室标准委员会EP9-A2文件,将Beckman DXC-800-1全自动生化分析仪作为参考仪器,同一型号DXC-800-2和LX20全自动生化分析仪作为待检仪器,收集新鲜血清标本,分别用3台全自动生化分析仪对14项常规生化项目进行测定,所有项目均进行相关性分析和偏倚评估。以美国临床医学检验部门修正法规(CLIA′88)允许总误差的1/2为标准,判断检验结果的可比性。结果:3台生化分析仪所有测定结果相关性良好,相关系数R>0.975,在临床决定水平浓度处,偏差均小于1/2允许总误差。结论:常规生化项目在实验室不同仪器间有较好的可比性,检测结果可满足临床要求。Objective To compare and evaluate the results of 14 biochemistry items in different biochemical analyzers, and to discuss comparability of determination results of three different automatic biochemical analyzers in the allowable range. Methods According to EP9-A2 document of National Committee for Clinical Laboratory Standards （NCCLS）, fresh serum samples were respectively analyzed by the reference instrument （Beckman DXC-800-1） and testing instruments （Beckman DXC-800-1 and LX20）. Correlation analysis and bias estimation were applied for all 14 items. The comparability of different biochemical analyzers were judged according to the half of allowed total error from clinical laboratory improvement amendment 88 （CLIA＇ 88）. Results All of 3 biochemical analyzers showed good correlation, with the correlation coefficient R more than 0.975. The biases of 14 biochemical items could be accepted at medical decision levels. Conclusion The routine biochemical items in the laboratory have a good comparability between different instruments, and the results are accurate enough for the clinical requirements. [Chinese Medical Equipment Journal, 2014,35 （7）：92-94]

关 键 词：全自动生化分析仪 方法比对 偏倚评估 

分 类 号：R446.1[医药卫生—诊断学]