全自动血细胞分析流水线网织红细胞参数参考区间在儿科实验室适用性验证

目的验证Sysmex-XN3000全自动血细胞分析流水线网织红细胞参数参考区间是否适合于儿科实验室。方法根据ISO 15189:2012《医学实验室质量和能力的要求》和美国病理家协会对实验室质量管理的要求和实验室认可的要求,参照美国临床和实验室标准化协会C28-A3文件推荐方法,对引用厂家试剂说明书的7项网织红细胞参数的参考区间进行实验验证。结果超过90%参考个体的网织红细胞绝对值、低荧光强度网织红细胞百分率、中荧光强度网织红细胞百分率、高荧光强度网织红细胞百分率和未成熟网织红细胞比率检测值落在厂家提供的参考区间以内,超过10%参考个体的网织红细胞百分数和网织红细胞血红蛋白水平检测值落在厂家提供的参考区间以外。结论厂家提供的网织红细胞参考区间不适合于儿科实验室,应自建儿童参考区间。

Applicability verification of reticulocytes parameters reference intervals of automatic blood cell analysis assembly line in pediatric laboratory

Objective To verify whether the reference intervals of reticulocytes parameters on Sysmex-XN3000 automatic blood cell analysis assembly line are suitable the pediatric laboratory .Methods According to the items of ISO15189 :2012 the Requirements of the Quality and Ability in Medicine Laboratory ,requirements of labo-ratory accreditation and laboratory quality management by the Association of American Pathologists and the methods recommended by the C28 and A3 document of American Clinical and Laboratory Standards Institute(CLSI) ,the ref-erence intervals of 7 reticulocytes parameters from the manufactory instructions were performed the laboratory verifi-cation .Results The detection results in reticulocyte absolute number ,low fluorescence intensity reticulocytes per-centage ,middle fluorescence intensity reticulocytes percentage ,high fluorescence intensity reticulocytes percentage and immature reticulocytes ratios in more than 90% of reference individuals were fallen within the reference intervals provide by the manufacturers ,But the reticulocyte percentage and reticulocyte hemoglobin level in more than 10% of individuals were fallen outside the reference intervals provided by the manufacturers .Conclusion The reticulocytes reference intervals provided by the manufacturer are unsuitable for the pediatric laboratory .The children reference intervals should be established by the laboratory itself .