生物学变异质量规范在血脂检测质量管理中的应用  

Application of biological variation quality standard in quality management of blood lipid detection

作　　者：赵敏[1] 杨贤芳[1] 戴宏华 许馨[2] 吴在荣 Zhao Min1, Yang Xianfang1, Dai Honghua1, Xu Xin2, Wu Zairong2(1.Department of Clinical Laboratory, Jurong, Jiang su, 212400, China; 2.Hospital of traditional Chinese medicine, Jurong, Jiangsu, 212400, China)

机构地区：[1]句容市中医院检验科,江苏句容212400 [2]句容市人民医院检验科,江苏句容212400

出　　处：《当代医学》2018年第19期61-63,共3页Contemporary Medicine

摘　　要：目的探讨以生物学变异质量规范在血脂测定质量管理中的应用。方法依据生物学变异及本院室内、室间质控数据,计算血脂每个项目实际变异系数(CV)、实际偏倚(Bias)、实际总误差(TE),将实际TE与不同生物学变异水平下允许总误差(TEa)进行比较,计算σ值、质量目标指数(QGI),以此评定方法性能、提出改进措施.结果血脂七项中高密度脂蛋白胆固醇(HDL-c)、低密度脂蛋白胆固醇(LDL-c)、载脂蛋白A1(APO-A1)、载脂蛋白B(APO-B)四项目CV未能达到生物学变异合适水平的质量目标,其余项目的CV均达到合适水平,在生物学变异质量目标为合适、最低的TEa时计算σ时,甘油三酯(TG)和脂蛋白a[LP(a)]的σ值都超过6,不需要采取措施;以最低TEa为目标时胆固醇(TCh)达到良好,但质量目标指数(QGI)值<0.8,可优先改进精密度,APO-A1、APO-B的σ值均<3,其准确度和精密度都不佳,HDL-c、LDL-c两项目QGI值均>1.2,应优先改善准确度,纠正偏倚后LDL-c达到良好,而HDL-c仍较差。结论以生物学变异TEa作为质量目标是血脂检测中提高σ水平、改善检测能力的重要手段。Objective Study on the application of biological variation quality standard in the quality management of Blood Lipid determination.Methods Based on the biological variation and internal and external quality control data, the actual coefficient of variation 、actual bias and actual total error for each item of blood lipids is calculated, Comparing the actual TE to the allowed total error（TEa） at different levels of biological variation,The calculation of σ value and quality target index QGI are used to evaluate the performance of the method and the improvement measures are put forward. Results The CV of HDL-c、LDL-c 、APO-A1、APO-B in seven items of lipids failed to meet the quality target of appropriate level of biological variation,The CV of the rest items reached the appropriate level,When the quality target of biological variation is suitable and the lowest TEa, the σ values of TG and LP（a） are both over 6, so no measures are needed,With the minimum TEa as the target, the TCh is good, but the QGI value is less than 0.8, which can give priority to improve the precision,The σ values of APO-A1 and APO-B are all less than 3, their accuracy and precision are not good,The QGI values of HDL-c and LDL-c are both greater than 1.2, so the accuracy should be improved first, and the LDL-c is good after correcting bias, but the HDL-c is still poor. Conclusions Taking biological variation TEa as the quality target is an important means to improve the level of σ and improve the ability of detection in the detection of blood lipids.

关 键 词：血脂 生物学变异 允许总误差 质量控制 

分 类 号：R446.1[医药卫生—诊断学]