235家临床实验室红细胞沉降率参考区间和医学决定水平的现况调查

目的调查全国235家实验室红细胞沉降率(ESR)参考区间和医学决定水平的现状。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ESR参考区间调查室间质量评价计划的实验室与参考区间和医学决定水平有关的结果。使用SPSS 13.0软件对所有参加的实验室结果进行分析,按照仪器对各实验室进行分组进行参考区间和医学决定水平的统计描述。结果参加调查ESR参考区间的实验室数量为235家,其中96家上报了医学决定水平。参考区间来源中,比例最高的为《全国临床检验操作规程》(80.85%),接下来依次为教科书(8.51%)、仪器试剂厂家说明书(6.38%)、实验室自己确定(2.98%)和其他。医学决定水平的来源中,最多的也是《全国临床检验操作规程》(75.00%),其次为仪器试剂厂家说明书(15.63%)。仅有45.11%和46.88%的参与实验室在使用参考区间和医学决定水平前对其进行了验证。分别有168家和72家实验室按照性别对ESR参考区间和医学决定水平进行了区分。男、女和未分组的参考区间上限和医学决定水平在不同仪器组无明显差异(P0.05)。结论我国ESR参考区间和医学决定水平的现况不尽如人意,目前急需一致的国家标准来指导实验室制订适当的ESR参考区间和医学决定水平。

Investigation and analysis of reference intervals and medicine decide levels of erythrocyte sedimentation rate in 235 clini-cal laboratories

Objective To investigate the current situation of reference intervals and medicine decide levels of e-rythrocyte sedimentation rate(ESR)in 235 clinical laboratories all over China.Methods The information related to reference intervals and medicine decide levels was collected by the external quality assessment software system based on website.The participants were classified according to their used instruments.The SPSS 13.0 software was used for conducting the data analysis and obtaining the statistical parameters of reference internals and medicine decide lev-els for each group.Results There were 235 laboratories participating in this investigation,among which 96 laborato-ries reported their medicine decide levels and related data.The primary source of reference intervals was national guide to clinical laboratory procedures (80.85%),followed by textbook (8.5 1%),instructions of instrument and rea-gent manufactures (6.38%),determined by their own laboratory (2.98%)and others.The primary source of medi-cine decide levels was also National Guide to Clinical Laboratory Procedures (75.00%),followed by instructions of instrument and reagent manufactures (1 5.63%).Only 45.1 1% and 46.88% of participant laboratories had the veri-fied reference intervals and medicine decide levels before clinical use,respectively.And 1 68 and 72 participant labora-tories considered different gender when establishing reference intervals and medicine decide levels,respectively.There were no significant differences among the reference intervals of different instrument groups(P >0.05).Conclusion The current situation of reference intervals of ESR in clinical laboratories all over China is unsatisfactory.At present the consistent national standards is urgently needed to guide laboratories to establish suitable reference intervals and medicine decide levels of ESR.