半胱氨酸蛋白酶抑制剂 C和β2微球蛋白参考区间的调查与分析  

Investigation and Analysis of Reference Intervals of Cystatin C andβ2-Microglobulin

作　　者：钟堃[1] 王薇[1] 何法霖[1] 张妍[1] 赵彦[1] 李国华[1] 王治国[1] 

机构地区：[1]北京医院卫生部临床检验中心,北京100730

出　　处：《现代检验医学杂志》2015年第4期32-34,38,共4页Journal of Modern Laboratory Medicine

基　　金：北京市自然科学基金资助项目（7143182）.

摘　　要：目的：了解医疗机构中半胱氨酸蛋白酶抑制剂 C 和β2微球蛋白这两个肾功能指标参考区间的应用现状。方法通过互联网向2014年参加卫生部临床检验中心特殊蛋白室间质量评价计划的单位发送半胱氨酸蛋白酶抑制剂 C 和β2微球蛋白的参考区间调查表，收到反馈结果后使用 Microsoft Excel 2007和 SPSS 13.0进行统计分析。内容包括：参考区间来源、统计学分析、正态性检验、不同检测系统与总体结果的比较，以及参考区间应用前的验证情况。结果分别有106和127家实验室上报了半胱氨酸蛋白酶抑制剂 C 和β2微球蛋白的结果，分别覆盖了24和29个省、自治区和直辖市。只有5家和2家实验室进行了参考区间的性别分组，有3家实验室进行了参考区间的年龄分组。约75％的实验室采用试剂厂家说明书所给出的参考区间。所有组的组中位数和众数基本一致。所有项目和分组第2.5和第97.5百分位数差异较大。半数以上的实验室都未进行参考区间的验证。参考区间下限和上限的中位数分别为（血清中）：半胱氨酸蛋白酶抑制剂 C （mg／L）0.55和1.09；β2微球蛋白（μg／ml）1.00和2.80。结论目前半胱氨酸蛋白酶抑制剂 C 和β2微球蛋白检验项目所应用的参考区间有一定的差异，所用仪器试剂和检测系统多样，建议建立适用于我国，并且较为规范和统一的参考区间。该次调查所得两个项目参考区间为：半胱氨酸蛋白酶抑制剂 C：0.55～1.09 mg／L；β2微球蛋白：1.00～2.80μg／ml。Objective To know the current application status of reference interval of cystatin C andβ2-microglobulin in medi-cal institutions of China.Methods Every laboratory which attended 2014 specific protein external quality assessment pro-gram of national center of clinical laboratories has been received an internet questionnaire to survey reference intervals of cystatin C andβ2-microglobulin.After eliminating outliers the trimmed data was statistical analyzed by Microsoft Excel 2007 and SPSS 13.0.The resources of RIs,traditional statistical analysis,normalized analysis,comparison between overall median and lower and upper limits of different measurement system,and verification status of RIs were included.Results 106 and 127 medical laboratories submitted the questionnaire and the number of province with submission of RIs for the two renal function measurement items were 24 and 29,respectively.Less than 5 laboratories grouped their RIs according to age and/or gender.Approximately 75% of laboratories had been using the RIs referring to reagent manufacturers’instructions.All me-dians of upper or lower limits of analytes were as same as the Mode values of the same group.The 2.5th percentiles had tre-mendous differences compared with 97.5th percentiles.More than half of laboratories did not verify their RIs beforeusing them.The overall medians of lower and upper limits of RIs were （in serum）：Cystatin C （mg/L）0.55 and 1.09;β2-micro-globulin （μg/ml）1.00 and 2.80.Conclusion The RIs of cystatin C and β2-microglobulin used in medical institution had some differences between each other,and there were too many kinds of reagents and instruments which made different meas-urement systems.The consistent and standardized reference intervals should be established in a short time.The RI for cysta-tin C was 0.55~1.09 mg/L,forβ2-microglobulin was 1.00~2.80 μg/ml considered by this study.

关 键 词：半胱氨酸蛋白酶抑制剂C Β2微球蛋白 参考区间 

分 类 号：R446.112[医药卫生—诊断学]