2012年全国凝血试验检验项目参考区间现状调查分析

The investigation of reference intervals application status of the analytes in coagulation test

目的 分析描述全国凝血试验检测项目参考区间的来源、分类以及上、下限值分布现状.方法 向参加2012年卫生部临床检验中心组织的凝血试验室间质评的临床实验室发放调查表,通过网络在线填报的方式收集各实验室凝血酶原时间（PT）、国际标准化比值（INR）、活化部分凝血活酶时间（APTT）和纤维蛋白原（Fbg）的参考区间来源及上、下限值.使用Microsoft Excel 2007和SPSS13.0软件将回报的数据进行整理,剔除不合理以及错误的数据,按照来源、上下限情况进行统计分析,包括算术平均数、中位数、最小值、最大值、百分位数（P25和P97.5）;根据试剂厂家分组,对分组后各项目参考区间情况进行方差分析以比较组间差异.结果 共403家实验室回报了结果.参考区间来源中所占比例最高的3项依次为：厂家说明书（56.33％～57.32％）、实验室自己确定（15.25％～21.34％）、全国临床检验操作规程（19.11％～23.00％）.90％的实验室对于PT、INR和Fbg的参考区间未按性别进行设置.对参考区间进行了性别分组的实验室得到的上下限差异较小.凝血试验各项目参考区间下、上限中位数为：①PT：男（10.3,14.4）s,女（10.8,14.4）s,混合组（10.0,14.0）s;②INR：男、女和混合组均为（0.80,1.20）;③APTT：男（25.0,40.0）s,女（24.5,40.0）s,混合组（23.0,38.5）s;④Fbg：男、女和混合组均为（2.0,4.0）g/L.各检测项目中部分试剂组的百分位数（2.5％～97.5％）参考区间上限内部和下限内部存在差异,不同试剂间P25和P975分布差异大.结论 本研究中各项目参考区间上、下限算术平均数和中位数较为接近,但P25和P97.5分布一致性较差.

Objective To investigate and analyze the reference interval application status of analytes in coagulation tests.Methods Every laboratories attended 2012 external quality assessment program were received an intemet questionnaire about the resource,grouping and ranges of analytes of coagulation test.By using Microsoft excel 2007 and SPSS 13.0 to analyze the submitted data and calculate the arithmetic averages,medians,maximum values,minimum values,and the 2.5% and 97.5% percentages after eliminating the outliers.The data of every analytes was divided into 4-5 subgroups by different kinds of reagents.Meanwhile,each subgroup was also conducted statistical analysis for further description.Results There were 403 laboratories submitting the investigation questionnaire.The top three resources of reference intervals were reagent manufacturer instruction （56.33%-57.32%）,calculated by laboratories themselves （15.25%-21.34%）,and national guide to clinical laboratory procedures （19.11%-23.00%）.Most laboratories did not conduct gender grouping in PT,INR and Fbg.The reference intervals conducted gender grouping had little difference from the medians.The median of lower and upper limits of analytes of coagulation test were as of follows：PT,male （10.3,14.4） s,female （10.8,14.4） s,totally （10.0,14.0） s; INR,male,female and totally （0.80,1.20）; APTT,male （25.0,40.0） s,female （24.5,40.0） s,totally （23.0,38.5） s; Fbg,male,female and totally （2.0,4.0） g/L.Some of lower and upper limits of subgroups of analytes of coagulation test had significant statistical differences between each other.The distributions of the 2.5% and 97.5% percentages of difference reagent manufacturers were not same as others.Conclusion There were little differences between the arithmetic averages and medians of the lower and upper limits of PT,INR,APTT and Fbg,but the consistencies of the distributions of the 2.5% and 97.5% percentages were not very well.The resources of reference intervals had some major categories.We suggest establishing new reference intervals to apply most parts of China.