生化部分常规项目干湿化学检测结果一致性分析

Consistency analysis on results of some routine biochemical items by dry and wet chemical methods

关键词:  干化学  湿化学  相关性分析

Key words:  dry chemical method  wet chemical method  correlation analysis

摘要:

目的　干湿化学分析仪对9项生化检验结果进行比对分析和偏倚评估，了解两检测系统的一致性，以及能否共用湿化学分析法参考区间。方法　依照美国临床实验室标准化协会（ＣＬＳＩ） EP9-A2 文件，以日立7600全自动生化分析仪为参比方法，美国强生VITROS600全自动生化免疫分析仪为实验方法，对血糖、尿素氮、肌酐、尿酸、钾、钠、氯、钙、磷测定的结果进行方法学比对、相关性分析和偏倚评估，并判断偏倚是否可以接受。对临床不可接受的项目依据两方法的线性回归方程进行校正，并对校正后的结果再进行相关性分析和临床可接受性评价。最后对各自的参考区间进行验证。结果　两种方法测定血糖、尿素氮、肌酐、尿酸、钾、钠、氯、钙、磷相关系数r≥0.95，血糖、尿素氮、肌酐、尿酸、钾、钠、氯、钙医学决定水平的系统误差均小于允许偏差EA的1/2，磷医学决定水平的系统误差大于允许偏差EA的1/2，校正干化学仪参数后，磷相关系数r≥0.95，磷医学决定水平的系统误差小于允许偏差EA的1/2。9项生化项目的参考区间验证均合格。结论　两检测系统血糖、尿素氮、肌酐、尿酸、钾、钠、氯、钙有可比性，磷经校正后相关性良好，有可比性，经参考区间验证，可共用参比方法的参考区间。

Abstract:

Objective According to the analysis comparison and the bias estimation of nine biochemical item results by Wet and dry chemistry analyzer，we want to understand the consistency of the two detection systems and if they can share the same reference interval.Methods According to CLSI EP9-A2 document，Hitachi 7600 automatic biochemical analyzer (as the reference method) and Johnson & Johnson Vitros600 automatic biochemical analyzer (as the laboratory method) were used respectively to determine blood glucose，blood urea nitrogen，creatinine，uric acid，potassium，sodium，chloride，calcium，phosphorus and evaluate the bias within methodological linear limitation.The bias of the biochemical item exceeding medical decision standard were adjusted based on the linear equation of the results determined by the two methods and then used for correlation analysis and acceptable evaluation.Finally，the respective reference intervals were verified.Results The correlation coefficient of Blood glucose，blood urea nitrogen，creatinine，uric acid，potassium，sodium，chloride，calcium by wet and dry chemistry analyzer were fine (r≥0.95) and the systematic error at the medical decision were clinically accepted (SE<1/2 CLIA′88).By correcting dry chemistry analyzer parameters，the correlation coefficient of phosphorus was fine (r≥0.95) and the systematic error at the medical decision was clinically accepted (SE<1/2 CLIA′88).The verification of nine Biochemical items were all qualified.Conclusion The results of blood glucose，blood urea nitrogen，creatinine，uric acid，potassium，sodium，chloride，calcium and corrected phosphorus are all comparable; they can share the reference interval of the reference method.