上海地区半胱氨酸蛋白酶抑制剂C室间质量评价结果分析  

Analysis on the results of external quality assessment of cystatin C in Shanghai

作　　者：唐立萍 欧元祝 王美娟 刘文彬 虞啸炫 居漪 

机构地区：[1]上海市临床检验中心生化室,上海200126

出　　处：《检验医学》2016年第8期713-717,共5页Laboratory Medicine

摘　　要：目的：通过对上海地区2014至2015年4次室间质量评价（简称室间质评）和2015年1次飞行检查结果的分析，了解上海地区半胱氨酸蛋白酶抑制剂C（Cys C）项目测定结果的整体情况，并为Cys C项目后续的室间质评计划和质控品的选择提供改进的依据。方法室间质评的质控品均来自英国朗道实验诊断有限公司的血清基质质控物，飞行检查调查品由上海市临床检验中心生化室自制的血清样本与上海北加生化试剂有限公司的血清样本组成，质控品浓度的覆盖范围为0.7～9.0 mg/L。室间质评结果统计以中位数为靶值，飞行检查调查结果采用一级参考物质传递赋值和以中位数为靶值2种方法统计。根据试剂品牌分国产试剂组、进口试剂组及其他试剂组，对各组结果分别进行统计分析。合格判断标准为靶值＆#177;25%，最后计算每组和总体变异系数（CV），以及每组和总体合格率。结果2014年2次室间质评和2015年飞行检查结果的总CV和分组CV大部分在15%～20%之间，但2014年第2次室间质评的高浓度样本（6.3、8.9 mg/L）CV均超过25%，国产试剂组和进口试剂组CV无明显差异；进口试剂合格率均超过90%，整体高于国产试剂，其中日本希森美康公司试剂测定结果普遍高于其他进口试剂品牌，国产试剂组在样本浓度为6.0 mg/L时，合格率最低，均不超过80%。2015年2次室间质评的质控品只有2个浓度，分别为0.7 mg/L与3.4 mg/L，2015年室间质评的总CV、分组CV和合格率均明显高于2014年室间质评和飞行检查，CV均在10%以内，合格率均在95%以上，但是第1次室间质评时，进口试剂积水（日本一化）在样本浓度（低值）为0.7 mg/L时检测值出现了集体低于下限的情况，导致该浓度样本进口试剂组只有68%的合格率。飞行检查5个血清样本结果采用一级参考物质传递赋值和以中位数为靶值2种方法统计比�Objective To know the status of cystatin C （Cys C） determination in Shanghai,through analyzing 4 external quality assessment and 1 flight-inspection-survey from 2014 to 2015,and to provide a reference for improving Cys C external quality assessment and the selection of quality control materials. Methods The quality control materials of external quality assessment were serum matrix quality control materials from Randox Company. The flight-inspection-survey specimens were serum samples prepared from the Clinical Chemistry Laboratory from Shanghai Center for Clinical Laboratory and from Shanghai Beijia Company. The concentration of quality control materials was 0.7-9.0 mg/L. The median of the results of external quality assessment was as target value. The flight-inspection-survey results were analyzed by primary reference material transfer target assignment value and median value. The results were classified into domestic reagent group,imported reagent group and other reagent group and＆amp;nbsp;analyzed statistically. The standard of qualified judgment was ＆#177;25%,and the group coefficients of variation （CV） and total CV were calculated,and group pass rates and total pass rate were also calculated. Results The total CV and group CV of 2 external quality assessment in 2014 and flight-inspection-survey in 2015 were 15%-20%,but the CV of high-concentration samples（6.3 and 8.9 mg/L） of the 2nd external quality assessment in 2014 were 〈25%. There was no difference for CV between domestic and imported reagent groups. The pass rate of imported reagent group （〈90%） was higher than that of domestic reagent group,and the results of Sysmex was higher than those of other imported reagents. In domestic reagent group,the pass rate was the lowest when the concentration of samples was about 6.0 mg/L,which was ＆lt;80%. The external quality assessment samples in 2015 had only 2 concentrations at about 0.7 mg/L and 3.4 mg/L. The total and group CV and the pass rates of external quality assessment in 2015 we

关 键 词：半胱氨酸蛋白酶抑制剂C 室间质量评价 飞行检查 上海 

分 类 号：R446.5[医药卫生—诊断学]