全国网织红细胞计数参考区间和决定限现状调查与分析

Investigation and Analysis of Reference Intervals and Decision Limits of Reticulocyte Count in China

目的调查目前中国网织红细胞计数参考区间的来源、上下限分布以及决定限的现状。方法利用基于 Web方式的室间质量评价软件系统，收集参加2014年网织红细胞计数参考区间调查的实验室参考区间上下限、临床决定水平、来源情况、方法原理、仪器和试剂等相关信息。按照仪器对各实验室进行分组，然后使用 SPSS19.0软件对各组结果进行统计描述。结果共276家实验室回报了有效结果。参考区间来源中所占比例依次为《全国临床检验操作规程》（53.99％）、仪器厂家说明书（16.30％）、教科书（9.78％）、试剂厂家说明书（9.06％）等。决定限来源中所占比例依次为《全国临床检验操作规程》（56.06％）、仪器厂家说明书（16.67％）、教科书（7.58％）、试剂厂家说明书（7.58％）等。不同组间的参考区间上下限以及临床决定水平的中位数与均值较为接近，但P2.5和P97.5差异较大。仅有45.65％和48.48％的实验室在使用参考区间和决定限前对其进行了验证。参考区间下限和决定限在不同组间无明显差异（P＞0.05），但参考区间上限在不同仪器组间差异具有统计学意义（P＜0.001）。结论中国网织红细胞参考区间现状不尽如人意，应建立适应中国大多实验室和主要检测仪器的参考区间和决定限，为网织红细胞技术的标准化工作提供参考。

Objective To investigate and analyze the current situation of reference intervals and decision limits of reticulocyte count in China.Methods The information related to upper/lower limits,decision limits,data resources,method principles, instruments and reagents of reticulocyte count in 2014 was collected via the external quality assessment software system based on website.The participants were divided according to their methods and instruments.The SPSS 1 9.0 was used for conducting the data analysis and statistics of results for each group.Results There were 276 laboratories submitting the val-id results.The major resources for reference intervals came from national guide to clinical laboratory procedures （53.99%）, instructions of instrument manufacturers （16.30%）,textbook （9.78%）,instructions of reagents manufacturers （9.06%） and others.The major resources for decision limits were national guide to clinical laboratory procedures （56.06%）,instruc-tions of instrument manufacturers （16.67%）,textbook （7.58）,instructions of reagents manufacturers （7.58%）and others. The medians and averages of upper/lower limits and decision limits among subgroups were close,whereas the P2.5 and P97.5 were significant discrepancies.Only 45.65% and 48.48% of participant laboratories had verified reference intervals and deci-sion limits before clinic use.The lower limits and decision limits among subgroups had nostatistical difference （P〉0.05）, where as the upper limits of different instrument groups had significant differences （P〈0.001）.Conclusion The current situation of reference intervals and decision limits of reticulocyte count is unsatisfactory.It is certain to establish a uniformed reference interval and decision limits for reticulocyte count,which provides a reference for the standardization of reticulocyte count testing.