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Chinese Journal of Clinical Laboratory Management(Electronic Edition) ›› 2026, Vol. 14 ›› Issue (01): 47-51. doi: 10.3877/cma.j.issn.2095-5820.2026.01.009

Special Issue:

• Standards, Guidelines and Consensus • Previous Articles     Next Articles

Interpretation of the health industry standard WS/T 461-2024 "Guideline for lycated hemoglobin A1C testing"

Tianjiao Zhang, Chuanbao Zhang, Wenxiang Chen, Jie Ma()   

  1. Beijing Hospital, National Center for Clinical Laboratories, Beijing 100730, China
  • Received:2026-01-12 Online:2026-02-28 Published:2026-02-28
  • Contact: Jie Ma

Abstract:

With the significant increase in the prevalence of diabetes in China, glycated hemoglobin (HbA1c), as a core indicator for the screening and diagnosis of diabetes, its detection accuracy and standardization are crucial for clinical diagnosis and treatment. In 2024, the National Health Commission issued WS/T 461-2024 "Guidelines for Glycated Hemoglobin Detection". As a revised version of the 2015 standard, this updated standard closely aligns with international advances and combines with China's clinical practice, further refining the quality control requirements throughout the entire process of HbA1c detection. Starting from the background, process and basic situation of the standard revision, this paper focuses on interpreting the core revised key points such as terminology and definitions, biological characteristics and clinical significance, technical requirements for the entire inspection process (pre-inspection, in-inspection, post-inspection), and quality control and assurance. The revision and implementation of this standard mark the deepening of the quality control requirements for HbA1c detection in China, which will promote the improvement of the quality and standardization level of HbA1c detection in China and provide a solid technical guarantee for the precise prevention and treatment of diabetes.

Key words: glycated hemoglobin, industrial standards, quality control

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