全国110家妇幼保健院及儿童医院检验科儿童全血细胞计数参考区间调查与分析

Investigation and analysis of the reference intervals for complete blood cell counting in 110 maternal and child health service centers and children′s hospitals in China

目的调查并分析全国110家妇幼保健院及儿童医院检验科儿童全血细胞计数参考区间来源及上下限现状。方法采用基于Web方式的室间质量评价(EQA)软件系统,收集2017年全国110家妇幼保健院及儿童医院检验科儿童全血细胞计数参考区间调查表结果。包括全血细胞计数18个项目的参考区间来源、是否进行验证、上下限、是否分组、所用方法、仪器、试剂和校准品等信息。使用Microsoft Excel 2007和SPSS 22.0对数据进行分析统计。获取中位数、P25、P75,以及对于各检测系统进行秩和检验,判断组间是否有统计学差异。结果剔除无效数据后得到110家实验室结果,参考区间主要来自于操作规程和实验室自己确定,其中50.5%~53.6%的实验室对参考区间进行了验证。白细胞计数参考区间从出生起逐步下降,到青少年期数值接近于成人水平。红细胞计数和血红蛋白测定参考区间除在新生儿期较高以外,其余各时期均接近于成人。红细胞比容参考区间数值随年龄增大有较缓的降低趋势。红细胞计数、血红蛋白测定和红细胞比容,参考区间在性别分组组间差异有统计学意义(P<0.05)。白细胞计数参考区间按性别分组实验室数较少(5家),组间差异无统计学意义。两种使用率较高的检测系统Sysmex XN series和Sysmex XS-800i/XS-1000i/XS 500i/XS 900i series使用的参考区间比较,组间差异无统计学意义。结论儿童全血细胞计数参考区间的建立是临床迫切需求,全血细胞计数项目参考区间在年龄和性别的差异均有统计学意义,建议按照年龄段和性别分组为依据制定儿童全血细胞计数参考区间的卫生行业标准。

Objective To investigate and analyze the source and upper and lower limits of the reference interval of children′s complete blood count in 110 maternal and child health hospitals and children′s hospitals nationwide. Methods Laboratories submitted the data of reference intervals via external quality assessment (EQA) software which was based on the web. To collect the results of reference intervals questionnaires on complete blood cell counting of children in laboratory departments of 110 maternal and child care service centers and children′s hospitals in China in 2017. Questionnaires include information on the source of reference intervals for 18 items of complete blood count, whether to verify, upper and lower limits, grouping, methods used, instruments, reagents, and calibrators. Data was analyzed using Microsoft Excel 2007 and SPSS 22.0. The median, P25, P75were obtained, and rank sum test were used to determine whether there were statistical differences between groups. Results The results of 110 laboratories were obtained after rejecting invalid data. The reference intervals were mainly derived from operating procedures and the laboratories themselves, of which 50.5%-53.6% of the laboratories were validated. The white blood cell counting reference intervals gradually decreased from birth to adolescence, and the value was close to that of adults. The reference intervals of red blood cell counting and hemoglobin were close to that of adults except in the neonatal period. The value of the reference intervals of hematocrit slightly decreased with age. The difference between RBC, Hgb, HCT in reference intervals between groups was statistically significant when grouped by gender (P<0.05). The reference intervals of white blood cell counting were less grouped by gender (5 laboratories), and the difference among groups was not statistically significant. There were no statistically significant differences in the reference intervals of elements between the two measurement systems that Sysmex XN series and Sysmex XS-800i/XS-1000i/XS 500i/XS 900i series. Conclusions The establishment of reference intervals for children′s complete blood cell counting was urgently needed. The reference intervals of the complete blood cell counting item had statistical significance in both age and gender. It was suggested that the industry standard of children′s complete blood cell counting reference intervals should be established based on age and gender.