血清半胱氨酸蛋白酶抑制剂C室间质量评价  

External quality assessment for measurement of serum cystatin C in China

作　　者：曾洁[1] 赵海建[1] 张天娇[1] 周伟燕[1] 闫颖[1] 张江涛[1] 汪静[1] 胡翠华[1] 马嵘[1] 张传宝[1] ZENG Jie;ZHAO Haijian;ZHANG Tianjiao;ZHOU Weiyan;YAN Yin;ZHANG Jiangtao;WANG Jing;HU Cuihua;MA Rong;ZHANG Chua- nbao(National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing 100730, China)

机构地区：[1]北京医院国家老年医学中心卫生部临床检验中心,北京100730

出　　处：《临床检验杂志》2018年第3期217-220,共4页Chinese Journal of Clinical Laboratory Science

基　　金：北京市科技计划(Z161100001816043)

摘　　要：目的了解我国血清半胱氨酸蛋白酶抑制剂C(Cys C)的检测质量现状。方法通过网络平台收集2017年参加Cys C室间质量评价用户检测数据,按试剂分8组(n≥18)并根据ISO13528统计各组稳健均值(Robust Mean)和稳健变异系数(Robust CV),设Robust Mean为靶值,以生物学变异导出的总误差3.8%(优)、7.6%(中)、11.4%(低)分别评价及格率。将用户数量不少于50的试剂组再按仪器分组,形成"试剂-仪器"组,计算各组中位数以及值最大组和值最小组之间的极差。结果2017年共710家实验室回报了Cys C检测结果,按3.8%、7.6%和11.4%来评价合格率分别为25.9%(184/710)、55.5%(394/710)、75.2%(534/710)。一种试剂与不同仪器组成的分析系统检测结果差异在1.62%~12.27%。结论我国Cys C检测质量尚需进一步提高。Objective To understand the current status of the measurement quality of serum Cystatin C（ Cys C） in China. Methods The external quality assessment（ EQA） data in 2017 were collected from the network platform of National Center for Clinical Laboratories. The EQA data were classified into 8 groups according to different types of diagnostic reagents,each of which was employed by at least 18 users. The robust mean value and robust coefficients of variation（ CV） were calculated according to ISO 13528 document in each group. The robust mean value was set as the target value. The total error derived from biological variation was used as the fine（ 3. 8%）,moderate（ 7. 6%） and weak（ 11. 4%） criteria in evaluating the pass rates,respectively. The reagents which were employed by more than 50 users were classified into subgroups named as ＂ reagent-analyzer＂ group according to the used analyzer. The median values and differentials between maximum and minimum value were calculated for each reagent-analyzer subgroup. Results A total number of 710 laboratories submitted their results of Cys C measurement during 2017. The fine,moderate and weak pass rates according to the setting criteria were 25. 9%（ 184/710）,55. 5%（ 394/710） and 75. 2%（ 534/710）,respectively. The variations of Cys C measurement results of among different reagent-analyzer groups ranged from 1. 62% to 12. 27%. Conclusion The quality of Cys C measurement of should be improved with nationwide attention.

关 键 词：半胱氨酸蛋白酶抑制剂C 肾小球滤过率 外部质量评价 能力验证 

分 类 号：R446.1[医药卫生—诊断学]