血脂测定结果的临床可接受性分析

目的:通过对不同检测系统血脂测定结果的偏倚评估,分析各系统间结果的可比性和临床可接受性。方法:参照CLSI文件相关要求,以可溯源的检测系统为目标检测系统,测定总胆固醇(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),对本院3个不同检测系统进行朗道质控物(水平2和水平3)各测定21次和测定新鲜血清标本40份。结果:朗道质控物和新鲜血清标本TCH、TG、APOA1、APOB、HDL-C、LDL-C浓度在系统间的差异均有显著性(P<0.05)。除LDL-C在各检测系统间的相关系数为0.7859~0.9259之间外,其他项目各系统间的相关系数均大于0.975。各检测系统测定TCH、TG的不精密度CV均小于5%,其他项目的不精密度CV均小于10%;以可溯源检测系统1为目标检测系统,临床可接受性能评价:TCH、LDL-C在检测系统2和检测系统3超出临床接受范围,HDL-C在检测系统2超出临床接受范围,其他项目临床均可接受。结论:3个不同检测系统测定TG、APOA1、APOB结果具有可比性;测定HDL-C结果具有部分可比性,TCH、LDL-C结果不具有可比性,需采取整改措施。

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

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.