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

Abstract:

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.

Key words: Performance specification, Differential blood count, Biological variation, State-of- the-art