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Chinese Journal of Clinical Laboratory Management(Electronic Edition) ›› 2026, Vol. 14 ›› Issue (01): 21-28. doi: 10.3877/cma.j.issn.2095-5820.2026.01.005

Special Issue:

• Standards, Guidelines and Consensus • Previous Articles     Next Articles

Understanding and application of GB/Z 43280-2023/ISO/TS 20914:2019 laboratories – guide to the assessment of measurement uncertainty”

Baorong Chen1, Liqin Wu2, Yingshu Zou3, Yan Shao4, Mingting Peng,5()   

  1. 1 Kingmeg Diagnostics(Beijing)Co.,Ltd, Beijing 100015, China
    2 Center for advanced measurement science. National institute of metrology, Beijing 100029, China
    3 IVD Laboratory, Beijing Institute of Medical Device Testing(Beijing Center for Testing and Research of Medical Biological Protective Equipment), Beijing 101111, China
    4 Department of Laboratory Medicine, Beijing Aerospace General Hospital, Beijing 100076, China
    5 Beijing Hospital, National Center for Clinical Laboratories, Beijing 100730, China
  • Received:2026-01-07 Online:2026-02-28 Published:2026-02-28
  • Contact: Mingting Peng

Abstract:

To support medical laboratory practitioners in better comprehending and applying the Guide to the Assessment of Measurement Uncertainty in Medical Laboratories (hereafter the Guidelines), this article provides a systematic overview of its key elements across three dimensions:the background of its publication, interpretation and application of its core concepts, and illustrative examples of practical application. Through comprehensive case studies, the article analyzes important concepts in measurement uncertainty assessment, such as long-term precision, bias, and bias correction, and clearly delineates the step-by-step assessment process. This work aims to enable readers to fully grasp the essence of the Guidelines and to effectively address the common challenges encountered in uncertainty evaluation within medical laboratory settings..

Key words: medical laboratory, measurement uncertainty, measurement uncertainty evaluation

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