Interpretation of the health industry standard WS/T 408-2024 "Verification of analytical performance of quantitative examination procedures"

doi:10.3877/cma.j.issn.2095-5820.2026.02.002

Abstract

Abstract:

The health industry standard WS/T 408-2024 "Guideline for the verification of analytical performance of quantitative examination procedures" was released in May 2024. The development of this standard fully considered national healthcare-related laws and regulations, domestic and international relevant standards, guidelines, consensus documents, literature evidence, practical experience, and expert opinions. The standard provides verification protocols for the 4 fundamental performance characteristics of quantitative examination procedures: Precision, trueness, linearity, and interference(specificity). This article provides an interpretation of the general principles of the guideline, the design of verification protocols for each performance characteristic, sample preparation, data processing, and result interpretation, aiming to assist relevant professionals and managers in better understanding and applying this standard.

Key words: quantitative examination procedures, performance verification, quality indicators, biological variation, industry standard

Xuejing Wang, Xiangyi Liu, Yun Zhou, Jing Wang, Chuanbao Zhang, Zhiguo Wang, Wenxiang Chen. Interpretation of the health industry standard WS/T 408-2024 "Verification of analytical performance of quantitative examination procedures"[J]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2026, 14(02): 104-109.

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References 29

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性能	方案设计	统计量	结果解释
精密度	2水平，共测5 d；每天1批，每批测3次。	S_WR、S_BR、S_WL	若S_WL≤S₀，为验证通过；若S_WL＞S₀，卡方检验有显著性为验证不通过。
正确度	2水平，每水平测10次；2个程序，测20份样品。	\|b\|、S_b	若\|b\|≤实验室规定偏倚，为验证通过；若2S_b ＞实验室规定偏倚，提示检验程序精密度不足或所选参考物质不确定度太大。
线性	5水平，每水平测3次。	S_WR、S_y/x、S_NL	若S_y/x≤S_WR，为验证通过；若S_y/x＞S_WR，F检验有显著性为验证不通过；若S_NL≤实验室规定非线性标准差，为临床可接受的非线性。
特异性	基础和干扰样品各测10次；2个程序，测20份样品。	\|d\|、S_d、S_PR、S_ss、S_d	若\|d\|≤实验室规定偏倚，为验证通过；若S_d≤S_PR，为验证通过；若S_d ＞S_PR，F检验有显著性为验证不通过；若S_ss≤实验室规定非特异标准差，为临床可接受非特异性。

性能	方案设计	统计量	结果解释
精密度	2水平，共测5 d；每天1批，每批测3次。	S_WR、S_BR、S_WL	若S_WL≤S₀，为验证通过；若S_WL＞S₀，卡方检验有显著性为验证不通过。
正确度	2水平，每水平测10次；2个程序，测20份样品。	\|b\|、S_b	若\|b\|≤实验室规定偏倚，为验证通过；若2S_b ＞实验室规定偏倚，提示检验程序精密度不足或所选参考物质不确定度太大。
线性	5水平，每水平测3次。	S_WR、S_y/x、S_NL	若S_y/x≤S_WR，为验证通过；若S_y/x＞S_WR，F检验有显著性为验证不通过；若S_NL≤实验室规定非线性标准差，为临床可接受的非线性。
特异性	基础和干扰样品各测10次；2个程序，测20份样品。	\|d\|、S_d、S_PR、S_ss、S_d	若\|d\|≤实验室规定偏倚，为验证通过；若S_d≤S_PR，为验证通过；若S_d ＞S_PR，F检验有显著性为验证不通过；若S_ss≤实验室规定非特异标准差，为临床可接受非特异性。

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