上海地区白细胞分类计数项目分析性能规范探索  

Performance specification for differential blood count project in Shanghai

作　　者：缪颖波 宋颖 赵强 诸佩超 周维 王青 徐翀 MIAO Yingbo;SONG Ying;ZHAO Qiang;ZHU Peichao;ZHOU Wei;WANG Qing;XU Chong(Clinical Hematology and Osology Laboratory,Shanghai Center for Clinical Laboratory,Shanghai 200126,China)

机构地区：[1]上海市临床检验中心临床血液体液学研究室,上海200126

出　　处：《检验医学》2021年第12期1274-1276,共3页Laboratory Medicine

基　　金：上海市卫生和计划生育委员会青年项目(20184Y0148)。

摘　　要：目的寻找一种适合白细胞分类计数项目能力验证的分析性能规范(简称性能规范),以持续有效地提高上海地区白细胞分类计数项目的检测水平。方法收集2015—2020年上海市临床检验中心12次共60批次白细胞分类计数能力验证活动数据,比较基于生物学变异和基于当前技术水平设定的性能规范评价各年份所有批次能力验证活动通过率,以通过率均≥80%的性能规范作为该项目的性能规范。结果所有批次中性粒细胞计数、嗜酸性粒细胞计数、嗜碱性粒细胞计数3个项目使用基于生物学变异设定的最佳性能规范(11.2%、18.6%、19.2%)时,通过率均≥80%;所有批次淋巴细胞计数项目使用基于生物学变异设定的最低性能规范(24%)时,通过率均≥80%;所有批次单核细胞计数项目使用基于当前技术水平设定的性能规范(<1时为±0.279;≥1时为±27.9%)时,通过率均≥80%。结论上海地区白细胞分类计数项目中,中性粒细胞计数、淋巴细胞计数、嗜酸性粒细胞计数和嗜碱性粒细胞计数可分别采用11.2%、24.0%、18.6%和19.2%的性能规范,单核细胞计数可采用±0.279(<1时)和±27.9%(≥1时)的性能规范。Objective To find a performance specification for differential blood count project,and to improve the determination level of differential blood count project in Shanghai continuously and effectively. Methods The data of 60 batches of differential blood count project for 12 times from 2015 to 2020 were collected,and the passing rates of all the batches in each year were evaluated according to the performance specifications based on biological variation and the state-of-the-art. The performance specifications with passing rates ≥80% were selected as the performance specifications for differential blood count project. Results All the batches of neutrophil,eosinophil and basophil passed ≥80% when using the optimal performance specification(11.2%,18.6% and 19.2%) based on biological variation. All the batches had a passing rate of ≥80% for lymphocyte when using the minimum performance specification(24%) based on biological variation. All the batches of monocyte were counted using a performance specification based on the state-of-the-art(<1,±0.279;≥1,±27.9%),and the passing rates were ≥80%.Conclusions The performance specifications for neutrophil,lymphocyte,eosinophil and basophil in Shanghai can be 11.2%,24.0%,18.6% and 19.2%,respectively,and those for monocyte<1 and monocyte≥1 are ±0.279 and ±27.9%,respectively.

关 键 词：分析性能规范 白细胞分类计数 生物学变异 当前技术水平 

分 类 号：R197.323.4[医药卫生—卫生事业管理]