血脂测定结果的临床可接受性分析

Bias Analysis On Serum Lipid Results Among Different Kinds Of Test Systems

血脂测定标准化是保证测定结果准确可靠的基础，标准化的核心是量值溯源。此目标的达到可以通过自建检测系统（不能溯源的检测系统）与目标检测系统（可溯源的检测系统）比对实验来实现。本文将我院检验科（总院和2个分院共3个实验室）中的一个实验室检测系统作为目标检测系统，与其他实验室所用自建检测系统测定的总胆固醇（TCH）、甘油三酯（TG）、载脂蛋白A1（ApoA1）、载脂蛋白B（ApoB）、高密度脂蛋白胆固醇（HDL—C）和低密度脂蛋白胆固醇（LDL—C）结果进行方法学比较，帮助纠正自建检测系统的偏倚，使自建检测系统检验结果可以溯源，提高临床可接受水平。

Objective: To discuss the comparability and acceptability of serum lipid results among different test systems through evaluating serum lipid results among different kinds of test systems.Method: 3 different kinds of biochemistry test systems were used to detect total cholesterol(TCH),triglyceride(TG),apolipoprotein A1(APOA_1),apolipoprotein B(APOB),high density lipoprotein cholesterol(HDL-C) and low density lipoprotein cholesterol(LDL-C) concentrations in 2 levels of Randox quality control and 40 fresh clinical sera according to CLSI file.The collected data were dealed with statistical analysis.Results: Analysis of Statistics showed TCH,TG,APOA_1,APOB,HDL-C and LDL-C results from different control and patients sera had significant differences in different test systems (P<0.05).The correlation coefficient of each test system was all above 0.975 except LDL-C.The CV value of imprecision of TCH and TG was less than 5,The CV value of imprecision of other items was less than 10.Target system 1 was regarded as target test system and evaluated the acceptability of other test systems.As a result,test system 2 and test system 3 were not accepted for TCH and LDL-C by clinical assessment,test system 2 was not accepted for HDL-C.Conclusion: The results of TG、APOA_1、APOB determined by 3 systems were ganerally comparative,and the result of HDL-C was partially comparative.The results of TCH and LDL-C were not comparative.It is necessary to perform method comparison and Bias estimation in order to insure comparability of results.