以血细胞分析为例浅谈医学参考测量实验室的建立

doi:10.3969/j.issn.1673-8640.2018.02.017

摘要/Abstract

摘要：

量值溯源是实现检验结果准确可比的重要手段,而量值溯源的实现依赖于医学参考测量系统的建立。医学参考测量实验室作为参考测量系统的一部分至关重要。关于医学参考测量实验室的建立和认可,国内外都是刚刚起步。文章以建立血细胞分析参考测量实验室为例,从量值溯源、质量控制、质量管理体系3个方面展开,介绍建立医学参考测量实验室的特殊要求和实践经验,为相关工作提供参考。

关键词: 参考测量实验室, 血细胞分析, 量值溯源, 质量控制, 质量管理体系

Abstract:

Traceability is important to realize the accuracy and comparability of clinical results,and relies on the establishment of reference system. Clinical reference measurement laboratory as a part of reference system is crucial. The establishment and accreditation of clinical reference measurement laboratory are still in infancy stage at home and abroad. This review focuses on the establishment of blood cell analysis reference laboratory as an example,in order to introduce practical experience and emphasize the characteristics of reference laboratory,from the aspects of value traceability,quality control and quality management system.

Key words: Reference measurement laboratory, Blood cell analysis, Value traceability, Quality control：Quality management system

中图分类号:

R446.1

康娟, 王会如, 孙京昇, 王军, 陈微. 以血细胞分析为例浅谈医学参考测量实验室的建立[J]. 检验医学, 2018, 33(2): 177-181.

KANG Juan, WANG Huiru, SUN Jingsheng, WANG Jun, CHEN Wei. Establishment of clinical reference measurement laboratory using blood cell analysis as an example[J]. Laboratory Medicine, 2018, 33(2): 177-181.

图/表 5

参考文献 26

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项目	量值	类型	概率分布	因子	标准不确定度	灵敏系数	换算后标准不确定度（g/L）
u_R	0.377 g/L	A		1	0.377 g/L	1	0.377
u_A	0.002 37	B		1	0.002 37	445.0 g/L	1.057
u_d	0.000 25 cm	B		1	0.000 25 cm	151.2 g/（L·cm）	0.038
u_D	0.074 μL	B	正态分布	2	0.037 ×10^–6L	1.506 ×10⁶ g/L²	0.056
u_F	0.030 mL	B	矩形	1.732	0.017 ×10^–3L	6.051 ×10³ g/L²	0.105
u_c							1.129
U（k=2）							2.300

项目	量值	类型	概率分布	因子	标准不确定度	灵敏系数	换算后标准不确定度（g/L）
u_R	0.377 g/L	A		1	0.377 g/L	1	0.377
u_A	0.002 37	B		1	0.002 37	445.0 g/L	1.057
u_d	0.000 25 cm	B		1	0.000 25 cm	151.2 g/（L·cm）	0.038
u_D	0.074 μL	B	正态分布	2	0.037 ×10^–6L	1.506 ×10⁶ g/L²	0.056
u_F	0.030 mL	B	矩形	1.732	0.017 ×10^–3L	6.051 ×10³ g/L²	0.105
u_c							1.129
U（k=2）							2.300

项目	浓度范围	相对扩展不确定度U_rel（k=2）（%）
RBC计数	（3.8~5.8）×10¹²/L	0.9
WBC计数	（3.5~9.5）×10⁹/L	2.2
Hb	125~175 g/L	1.5
HCT	35%~50%	0.8
PLT计数	（125~350）×10⁹/L	2.8

项目	浓度范围	相对扩展不确定度U_rel（k=2）（%）
RBC计数	（3.8~5.8）×10¹²/L	0.9
WBC计数	（3.5~9.5）×10⁹/L	2.2
Hb	125~175 g/L	1.5
HCT	35%~50%	0.8
PLT计数	（125~350）×10⁹/L	2.8