490家临床实验室甲状腺功能5项参考区间现况调查

Investigation on 5 item reference intervals of thyroid function among 490 clinical laboratories in China

目的调查全国范围内490家临床实验室甲状腺功能5项参考区间的现状,为其进一步规范提供参考。方法利用基于Web方式的室间质量评价系统,收集参加卫生部临床检验中心2014年内分泌参考区间调查室间质量评价计划的所有(490家)临床实验室甲状腺功能5项的结果,包括其参考区间的来源、分组方式、参考区间上下限、所用方法、仪器、试剂和校准品等信息。使用Microsoft Excel 2007和SPSS 19.0软件对调查结果进行分析,获取均值、中位数、百分位数(P_(2.5)和P_(97.5))。按照检测系统对各临床实验室进行分组并对主要系统组甲状腺功能5项的参考区间上下限进行描述,并绘制各项目各系统组结果的箱式图。结果各项目的参考区间主要来源为试剂厂家说明书(90.34%)、全国临床检验操作规程(3.75%)、实验室自定(3.57%)和其他(2.34%)。仅有少量临床实验室按照不同的年龄、性别分组来制定参考区间。几乎所有检测项目在不同检测系统中的参考区间上下限都有显著差异,即便使用相同检测系统的实验室,其各项目的参考区间也有明显差异。结论目前,我国临床实验室甲状腺功能5项参考区间的现况不尽如人意,大多数实验室未建立针对自己患者人群的参考区间,急需一致的国家标准来指导其制定适当的参考区间。

Objective To investigate the current situation of 5 item reference intervals of thyroid function among 490 clinical laboratories in China,and to provide a reference data for promoting harmonization Methods The data of 5 item reference intervals of thyroid function were collected from the National Center for Clinical Laboratories by endocrine reference interval investigation external quality assessment program 2014 based on website（490 clinical laboratories）,which included sources,classification,upper and lower limits of reference intervals,methods,instruments,reagents and calibrators. Microsoft Excel 2007 and SPSS 19.0 were used to obtain mean,median and percentiles（P_（2.5） and P_（97.5）） of upper and lower limits of reference interval for all groups. The box plot of each group for each analyte was drawn. Results The primary source of reference intervals was instructions of reagent manufacturers（90.34%）,followed by the National Guide to Clinical Laboratory Procedures（3.75%）,being determined by their own laboratories（3.57%） and others（2.34%）. Only a few laboratories had considered different age and sex groups when establishing reference intervals. There were differences for the reference intervals of different test systems,and the reference intervals of laboratories using the same test system also varied widely. Conclusions The current situation of 5 item reference intervals of thyroid function among clinical laboratories in China is not good. Most clinical laboratories have not established their own reference intervals of thyroid function for specific population. Therefore,national standards are needed for the reference intervals of thyroid function in China.