干湿化学法检测生化项目结果偏倚的校正研究  

Study on the Means to Adjust the Results Bias of Routine Biochemical Items between Dry and Wet Chemical Methods

作　　者：曹建华[1] 刘倩如[1] 程明刚[1] 蔡朝民[1] 叶国强[1] 

机构地区：[1]南方医科大学附属深圳宝安医院检验科,广东深圳518101

出　　处：《河北医学》2011年第6期729-732,共4页Hebei Medicine

摘　　要：目的:研究干、湿化学法检测生化项目结果偏倚的校正方法,以保障其结果的可比性。方法:回顾性分析2006年卫生部临床检验中心干、湿化学室间质评的回报结果,以湿化学回报结果的靶值作为比较方法(X)的实测值、干化学回报结果的靶值作为实验方法(Y)的实测值,计算两方法各项目测定结果的线性方程、相关系数并以美国CLIA’88对室间评估允许误差的1/2为判断依据进行临床可接受性评价。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,并对校正后的结果进行临床可接受性评价。结果:两法校正前除Ca2+、CK外其余项目线性关系良好(r均>0.975),两法校正前测定K+、Cl-、Ca2+、Glu的结果偏倚临床可接受,Na+、Cr、AST、CK的结果偏倚部分临床可接受,Bun、LDH和AMY的结果偏倚临床完全不接受。干化学法5个项目Bun、Cr、AST、LDH和AMY校正后的结果与湿化学法的相关性良好(r均>0.975),且校正后的结果偏倚,除了Cr低水平和AST高水平以外,其它的结果偏倚均临床可接受。结论:干、湿化学法检测某些生化项目的结果存在较大偏倚,部分结果可以依据比对试验得到的回归方程进行校正,因此同一实验室同时应用干、湿化学分析仪时,要保证二者结果的可比性,必须进行结果比对和校正。Objective：To explore the means to adjust the results bias and to ensure the results comparability of routine biochemical items between dry and wet chemical methods.Method：This retrospective study was based on the data in 2006 of external quality assessment（EQA） from national center for clinical laboratory（NCCL）.The EQA target values of routine biochemical items determined by wet（comparison method） and dry（test method） chemical methods were used as their own measured values,the correlation coefficient and linear equation and the anticipated bias between the two methods was estimated.The bias of some biochemical items exceeded half of allowable error of CLIA’88 in the different points of medical decision standard,will be adjusted based on the linear equation of the results determined by the two methods.Result：There was a better correlation（not including Ca^2＋ and CK） between the uncorrected results determined by the two methods（r〉0.975）,and except Bun,LDH and AMY,which bias were not acceptable,the bias of K^＋,Cl^-,Ca^2＋ and Glu were clinical accepted,the rest items Na＋,Cr,AST and CK were partially clinical accepted,but the bias of Bun,Cr,LDH and AMY,which had been adjusted the results based on the linear equation,could be completely clinical accepted and the corrected results of Bun,Cr,LDH and AMY had a better correlation with those of wet chemical methods（r〉0.975）.Conclusion：There is significant bias in some tests between the two methods and some bias could be corrected and accepted clinically.In order to ensure the comparability in the same clinical laboratory,it is necessary to do result comparison and bias estimation and result adjusting between dry and wet chemical methods.

关 键 词：干化学法 湿化学法 结果比对 偏倚 校正 

分 类 号：R446.1[医药卫生—诊断学]