血清Lp-PLA2质量与活性检测结果的一致性评价  

Consistency evaluation of quality of serum Lp-PLA2 and activity detection results

作　　者：陈孝红[1] 马润[1] 陶淑 李美玲[1] 马婷 李庆蓉[1] CHEN Xiaohong;MA Run;TAO Shu;LI Meiling;MA Ting;LI Qingrong(Department of Clinical Laboratory,Second Affiliated Hospital of Kunming Medical University,Kunming,Yunnan 650101,China)

机构地区：[1]昆明医科大学第二附属医院检验科

出　　处：《检验医学与临床》2019年第23期3401-3404,3409,共5页Laboratory Medicine and Clinic

基　　金：云南省科技厅-昆明医科大学联合专项（2017FE467(-179））

摘　　要：目的评价两种测定脂蛋白相关磷脂酶A2(Lp-PLA2)质量与活性的试剂在雅培C16000自动生化分析仪上检测结果的一致性。方法根据美国临床和实验室标准化协会(CLSI)文件相关要求,评价两种试剂的精密度、正确度、线性范围及参考区间,同时对A、B两种试剂检测患者标本的一致性进行评价。结果A试剂和B试剂各水平重复性分别为1.96%和2.43%、0.58%和0.78%,实验室内精密度分别为3.10%和3.23%、0.76%和1.96%,均小于厂商声称的重复性,即A试剂重复性≤5%,B试剂重复性≤10%;正确度验证A试剂和B试剂偏倚分别为0.33%和2.17%、2.94%和3.92%,均小于所选用的1/2允许总误差(12%)的标准;线性范围A试剂为29.0~792.5ng/mL,B试剂为74~1486U/L,回归系数R2分别为0.9970和0.9996,相关系数(r)分别为0.9985和0.9998,A、B试剂线性均符合CLSI EP6-A文件及试剂厂家的要求;A、B两种试剂方法学比较中,回归系数R2=0.5991,r=0.7740,两种试剂检测方法间有一定相关性,但一致性较差;参考区间A试剂的验证范围:10~200ng/mL,B试剂的验证范围:男性230~728U/L,女性194~640U/L(18~49岁),208~698U/L(50~88岁),均通过验证,两种试剂厂家提供的参考区间可运用于临床。结论两种应用于全自动生化分析仪C16000测定Lp-PLA2的试剂精密度、正确度及线性均良好,提供的参考区间可用,但两种试剂方法学间比较一致性较差。Objective To evaluate the consistency of detection results of two reagents for determining the quality and activity of lipoprotein associated phospholipase A2(Lp-PLA2)on the Abbott C16000 automated biochemical analyzer.Methods According to the requirements of CLSI documents,the precision,accuracy,linear range and reference interval of the two reagents were evaluated,and at the same time the consistency of A and B reagents for detecting the patients′samples was evaluated.Results The repeatabilities of the reagent A and B at each level were 1.96%and 2.43%,0.58%and 0.78%respectively,and the intra-laboratory precisions were 3.10%and 3.23%,0.76%and 1.96%respectively,both of them were less than the repeatability claimed by the manufacturer,repeatability lower 5%for the reagent A and repeatability lower 10%for the reagent B;in the trueness verification,the biases of the reagent A and B were 0.33% and 2.17%,2.94% and 3.92% respectively,which were less than the standard of the selected 1/2 allowable total error(12%);in the linear range,the reagent A was 29.0-792.5 ng/mL,and the reagent B was 74-1 486 U/L.The regression coefficient R2 of reagent A and B were 0.997 0 and 0.999 6 respectively,and the correlation coefficient r were 0.998 5 and0.999 8 respectively.The linearity of the reagents A and B conformed to the document of CLSI EP6-A and the requirements of the reagent manufacturer.In the methodological comparison of the reagents A and B,the regression coefficient R2 was 0.599 1,and the correlation coefficient r was 0.774 0,which showed that there was a certain correlation between the two reagent detection methods,but the consistency was poor.The verification range of reference interval for the reagent A was 10-200 ng/mL,which of the reagent B was 230-728 U/L for male,194-640 U/L for female(18-49 years old),208-698 U/L for female(50-88 years old),both passed the verification,and the reference intervals provided by the two reagent manufacturers could be used for clinic.Conclusion The two reagents for the determination

关 键 词：脂蛋白相关磷脂酶A2 精密度 正确度 线性范围 性能验证 

分 类 号：R446[医药卫生—诊断学]