全国2869家医院临床实验室全血细胞计数项目参考区间使用情况调查与分析

Investigation and analysis on the use of blood cell counting reference intervals in 2869 hospitals in China

目的调查我国全血细胞计数项目参考区间使用和行业标准引用情况。方法利用网络调查表形式收集参加2019年全血细胞计数18个项目参考区间调查的所有实验室的信息。包括实验室参考区间的来源、是否对参考区间进行验证、参考区间上下限、所用方法、仪器、试剂和校准品等信息。利用Microsoft Excel 2007软件分析所有回报实验室的结果,获取中位数、众数和95%置信区间,对全血细胞计数项目参考区间的分布和行业标准的一致性情况进行分析。结果全国共计2869家实验室回报了数据。参考区间的来源主要为行业标准和临床检验操作规程,所占比例分别为33.30%~35.02%和28.55%~30.90%。49.44%~55.13%的实验室引用行业标准时进行了验证。红细胞、血红蛋白和血细胞比容3个项目中引用行业标准组大部分实验室(89.37%~91.69%)的参考区间分组与行业标准一致。参考区间上下限与行业标准给出的上下限比较,平均红细胞血红蛋白浓度、中性粒细胞绝对值、嗜碱性粒细胞绝对值、单核细胞绝对值、淋巴细胞百分数参考区间下限;中性粒细胞百分数参考区间上限;平均红细胞容积、平均红细胞血红蛋白量、嗜酸性粒细胞绝对值、嗜碱性粒细胞百分数、单核细胞百分数参考区间上下限的中位数和众数相等且与行业标准给出的一致,其余项目实验室使用参考区间上下限与行业标准给出的参考区间不一致。结论全血细胞计数项目参考区间的使用不尽相同,且行业标准的实施情况并不乐观,有相当一部分实验室未对参考区间进行验证,因此推广参考区间行业标准很有必要。

Objective To investigate the use of the reference intervals for blood cell counting and the reference of industry standard in China.Methods Information from all laboratories was collected using online questionnaire in 18 reference intervals survey in blood cell counting in 2019.The information includes the source of the reference intervals,the verification of the reference intervals,and the upper and lower limits of the reference intervals,the method used,the instrument,the reagent and the calibrator.Microsoft Excel 2007 software was used to analyze the results of all laboratories.The median and 95%confidence interval were calculated.The distribution of the reference intervals for blood cell counting and their conformance to industry standards were analyzed.Results 2,869 labs reported the data.The main sources were industry standards and National Guide to Clinical Laboratory Procedures.The proportion was 33.30%-35.02%and 28.55%-30.90%respectively.49.44%-55.13%of laboratories validated the reference interval when citing industry standards.The reference interval grouping of most laboratories(89.37%-91.69%)cited in RBC,Hgb and Hct were consistent with the industry standards.We compared the upper and lower limits of the reference intervals with that given by the industry standards,when the lower limit of the reference intervals of mean corpuscular hemoglobin concentration,absolute neutrophils count,absolute basophils count,absolute monocyte count,and lymphocyte percentage were compared.The upper limit of reference intervals of neutrophils percentage as well as upper and lower limits of reference intervals of mean corpuscular volume,mean corpuscular hemoglobin,absolute eosinophil count,basophils percentage,and monocyte percentage were also compared.The median and mode were equal and consistent with industry standards.For other labs,the upper and lower limits of the reference intervals were not consistent with the reference intervals given by the industry standards.Conclusion The use of reference intervals for blood cell counting was not the same,and the implementation of industry standards was not optimistic.A considerable number of laboratories had not verified the reference intervals,so it was necessary to promote the industry standards for reference intervals.