论文部分内容阅读
目的 了解我国血清半胱氨酸蛋白酶抑制剂C (CysC)的检测质量现状.方法 通过网络平台收集2017年参加CysC室间质量评价用户检测数据,按试剂分8组(n≥18)并根据IS013528统计各组稳健均值(Robust Mean)和稳健变异系数(RobustCV),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CysC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CysC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 (CysC) 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 CysC 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 CysC measurement results of among different reagent-analyzer groups ranged from 1.62% to 12.27%.Conclusion The quality of CysC measurement of should be improved with nationwide attention.