特殊蛋白检验项目参考区间的调查与分析

摘要

目的：了解目前医疗机构中特殊蛋白检验项目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评计划的单位发送特殊蛋白参考区间调查表，收到反馈结果后使用 Microsoft Ex-cel 2007和 SPSS 13．0进行统计分析，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847家医疗机构中有667家汇报了结果，回报率78．7％。接近80％的实验室都采用试剂厂家说明书所给出的参考区间。其中只有不到10家单位进行了参考区间的分组。84．6％的项目中位数和 Mode 值一致。除部分项目参考区间下限外，第2．5和第97．5百分位数差异较大。检测系统应用数量从多到少排列为：Beckman、Siemens 和 Roche，而 Roche 系统中各检验项目参考区间与总体比较出现显著统计学差异的情况最少，为27．3％（6／22）。半数以上的实验室都未能在参考区间应用前进行参考区间的验证。特殊蛋白各项目参考区间下限和上限中位数分别为（血清中）：IgA（g／L）0．7和4．0；IgE（KIU／L）0和100；IgG（g／L）7．0和16．0；IgM（g／L）0．4和2．3；C3（g／L）0．8和1．8；C4（g／L）0．1和0．4；CRP（mg／L）0．0和8．0；RF（KU／L）0和20；ASO（KIU／L）0和200；转铁蛋白（g／L）2．0和3．6；前白蛋白（mg／L）200．0和400．0。结论目前全国医疗机构特殊蛋白检验项目所应用的参考区间差异较大，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。%Objective To know the current application status of reference interval of specific proteins in medical in-stitutions 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 about reference interval.After eliminating outliers the trimmed data has been statistical analyzed by Microsoft Excel 2007 and SPSS 13.0.The re-sources of RIs,traditional statistical analysis,normalized analysis,comparison between overall median and lower and up-per limits of different measurement system,and verification status of RIs were included.Results 667 medical laborato-ries submitted the questionnaire,the rate is 78.7% (667/847).Approximately 80% of laboratories have been using the RIs referring to reagent manufacturers’instructions.Only less than 10 laboratories use RIs divided into different sub-groups.84.6% of medians of upper or lower limits of analytes are same as the Mode values.The 2.5th percentiles have tremendous differences compared with 97.5th percentiles,except several lower limits.The numbers of different meas-urement systems used in medical institutions in descending order are Beckman,Siemens and Roche measurement sys-tem.Compared with the overall medians of lower and upper limits,the RIs of Roche measurement system has more like-ly closer limits than others,only 27.3% (6/22)of the limits have statistical significance differences.More than half of laboratories do not verify their RIs before using them.The overall medians of lower and upper limits of specific protein analytes are (in serum):IgA (g/L)0.7 and 4.0;IgE (KIU/L)0 and 100;IgG (g/L)7.0 and 16.0;IgM (g/L)0.4 and 2.3;C3 (g/L)0.8 and 1.8;C4 (g/L)0.1 and 0.4;CRP (mg/L)0.0 and 8.0;RF (KU/L)0 and 20;ASO (KIU/L)0 and 200;transferring (g/L)2.0 and 3.6;prealbumin (mg/L)200.0 and 400.0.Conclusion The RIs of specific protein analytes used in medical institution have big difference between each other,and there are too many kinds of reagents and instruments which make different measurement systems.The consistent and standardized reference intervals should be established in a short time.