全国常规化学检验项目参考区间现状调查分析

Investigation and analysis of reference intervals of routine clinical chemistry assays in China

目的 描述常规化学检验项目参考区间上下限回报结果以及来源,比较北京地区的参加单位常规化学与干化学各项目参考区间的差异.方法 把卫生部临床检验中心2010年全国常规化学和干化学第3次室间质量评价回报结果中各项目的参考区间信息纳入研究.剔除所有妇幼保健院、儿童医院和公司的结果,以及所有异常值和错误数据（如下限高于上限、上下限相同等）,并对全国参评单位常规化学和干化学参考区间的基本情况以及来源（如果存在性别间差异则报告成年男性水平）进行描述.使用SPSS 13.0分析北京市参评单位常规化学与干化学各项目参考区间的差异.结果 参考区间来源中所占比例最高的3项包括临床检验操作规程483家（47.6％）、试剂厂家说明书295家（29.1％）以及实验室自己确定124家（12.2％）.在北京地区参加单位常规化学和干化学参考区间的比较中,有6项下限及上限差异均有统计学意义,有4项出现单侧界限差异有统计学意义.结论 目前各医疗机构常规化学项目参考区间差异明显,来源不统一,各医疗单位常规化学与干化学项目参考区间只有少数项目存在统计学显著性差异,但是否具有临床实际意义有待进一步研究.为了实现医疗机构检验结果互认,必须在标准化基础上,在一定区域内共享相同的参考区间.

Objective To describe upper and lower limits and their sources of reference intervals in routine chemistry assays and to make a comparison between routine and dry chemistry in these aspects.Methods The data of reference intervals were collected,which come from the third run of 2010 External Quality Assessment （EQA） programs in routine and dry chemistry performed by National Center for Clinical Laboratories（NCCL）.All data from maternal and child care service center,children＇s hospital and corporations were excluded.Then all the abnormal values and errors （for instance,the lower limit was higher than the upper one or the upper limit was as the same as the lower one,etc.） were eliminated,either.Data statistics was performed by SPSS 13.0 referring to upper and lower limits of reference intervals and sources of 24 routine chemistry assays （ including serum potassium and serum sodium,etc）.Comparison was made between routine and dry chemistry in these aspects in 23 assays.Data from adult men were reported when gender difference was present.Results The three main sources of reference intervals were National Guide to Clinical Laboratory Procedures, instructions of reagent manufactures and determined by their own laboratory.In comparison of reference intervals between routine and dry chemistry,6 assays had statistical significant difference in both upper limits and lower ones while,4 assays in one-sided limits and 13 assays were not statistically significant in both limits.Conclusions The reference intervals of routine chemistry have big differences among institutions and the sources of them are various.Only a few assays have statistical significant difference in routine and dry chemistry among medical institutions,it might be discussed in further study whether the statistical results have clinical values.In order to achieve the result agreement among clinical assays,all the laboratories must share the common reference intervals on the basis of standardization.