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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。
Objective To verify whether the Sysmex-XN3000 fully automatic hematology analysis assembly line reticulocyte parameter reference interval is suitable for pediatric laboratories. Methods According to the requirements of ISO 15189: 2012 “Quality and Capability of Medical Laboratory” and the requirements of American Society of Pathologists for laboratory quality management and laboratory accreditation, according to the recommendation of C28-A3 of American Society of Clinical and Laboratory Standards, Referencing the manufacturer’s reagent manual 7 reticulocyte parameters reference interval for experimental verification. Results The absolute value of reticulocytes, the low fluorescence intensity reticulocyte percentage, the medium fluorescence intensity reticulocyte percentage, the high fluorescence intensity reticulocyte percentage and the immature reticulocyte ratio of more than 90% of the reference individuals fell on the manufacturers’ Within the reference interval, the reticulocyte percentage and reticulocyte hemoglobin level of more than 10% of reference individuals fall outside the reference range provided by the manufacturer. Conclusion The reference range of reticulocytes provided by the manufacturer is not suitable for pediatric laboratories, self-built reference range for children.