免疫比浊法检测ApoB的精密度、正确度、分析测量范围确认方案与实验方法的探讨  

Discussion on the velidation scheme and experimental method of detecting ApoB precision,accuracy,analytical measurement range by immunoturbidimetric assay

作　　者：辛小亮 单汉明 杨丽红 邱美菊 张世国 XIN Xiaoliang;SHAN Hanming;YANG Lihong;QIU Meiju;ZHANG Shiguo(Hangzhou DIAN Medical Laboratory Center,Hangzhou,Zhejiang Postcode 310030,China)

机构地区：[1]杭州迪安医学检验中心,浙江杭州310030

出　　处：《国际检验医学杂志》2019年第S02期65-69,共5页International Journal of Laboratory Medicine

摘　　要：目的探讨并建立实验室临床化学自建检测系统性能确认的方法。方法方法学评价研究。以血清载脂蛋白B(ApoB)测定为例,设定项目分析质量目标,以1/4PT(7.5%)为重复性允许误差、1/3PT(10%)为中间精密度允许误差,1/2PT(15%)为允许偏倚误差;精密度确认方案:选择2个水平伯乐质控品进行重复性及中间精密度实验,计算重复性与中间精密度;正确度确认方案:使用5份能力验证(PT)样本,计算各样本相对偏倚,同时使用40例新鲜血清样品与参比方法比对,评估参考区间上限及下限处的相对偏倚;分析测量范围(AMR)确认:选择高、低浓度样品各1份,按适当比例混合制备一系列线性评价样本,用EP6-A方案确定分析测量范围(AMR)。结果2个水平质控品重复性CV及中间精密度CV均小于6σ水平(5%);正确度5份PT样本偏倚分别为5.84%、0.20%、5.11%、9.70%、3.86%,实验方法与参比方法比对,在参考值上限和下限出的相对偏倚均在置信区间内,相对偏倚分别为-1.7%、9.8%;分析测量范围确认ApoB在0.31~2.34 g/L的范围内,为临床可接受的线性关系。结论该自建系统测定ApoB的精密度、正确度符合性能要求,且与参比方法比对结果评价一致,临床可接受的分析测量范围为0.31~2.34 g/L。Objective To explore and establish a method to velidation the performance of clinical chemical self-built detection system.Methods Methodology evaluation research.Taking the measurement of serum apolipoprotein B(ApoB)as an example,set the quality objectives of the analysis,with 1/4 PT(7.5%)as the allowable repeatability error,1/3 PT(10%)as the allowable intermediate precision error,and 1/2 PT(15%)as the allowable bias error.Precision velidation protocol:selecting two levels of BioRed quality control,calculating repeatability and intermediate precision;Accuracy velidation protocol:5 PT samples were used to calculate the relative bias of each sample.Meanwhile,40 fresh serum samples were used to compare with the reference method to evaluate the relative bias at the upper and lower limits of the reference interval.Determination of analytical measurement range(AMR):1 set of low-concentration samples and 1 set of high-concentration samples were selected and mixed to prepare a series of linear evaluation samples at an appropriate ratio,Determine AMR by EP6-A scheme.Results The repeatability CV and intermediate precision CV of 2 quality control products were less than 6 sigma(5%).The bias of the 5 PT samples was 5.84%,0.20%,5.11%,9.70%,and 3.86%,respectively.The experimental method was compared with the reference method.The relative deviations from the upper and lower limits of the reference values were within the confidence interval,and the relative deviations were-1.7%and 9.8%,respectively.The analysis and measurement range confirmed that ApoB was within the range of 0.31-2.34g/L,which was a clinically acceptable linear relationship.Conclusion the precision and accuracy of the self-built system in the determination of ApoB meet the performance requirements,and are consistent with the evaluation results of the reference method.The clinically acceptable analytical measurement range is 0.31-2.32g/L.

关 键 词：自建检测系统 性能确认 精密度 正确度 分析测量范围 

分 类 号：R28[医药卫生—中药学]