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Chinese Journal of Clinical Laboratory Management(Electronic Edition) ›› 2026, Vol. 14 ›› Issue (01): 36-41. doi: 10.3877/cma.j.issn.2095-5820.2026.01.007

Special Issue:

• Standards, Guidelines and Consensus • Previous Articles     Next Articles

Interpretation of the international committee for standardization in hematology guidance on the validation of laboratory developed tests in haemostasis

Xiaowei Qi1,(), Chengshan Xu2, Mingting Peng2   

  1. 1 Beijing Stago Diagnosis Trading Co., Ltd., Beijing, 100028, China
    2 Beijing Hospital, National Center for Clinical Laboratories, Beijing, 100730, China
  • Received:2026-01-06 Online:2026-02-28 Published:2026-02-28
  • Contact: Xiaowei Qi

Abstract:

Thrombosis and hemostasis testing plays a pivotal role in the diagnosis, treatment, and monitoring of bleeding and thrombotic disorders. Due to the specialized characters and clinical demands, clinical laboratories carry out laboratory developed tests (LDT) to varying degrees. LDT must be validated to ensure that the performance meets clinical needs before they are introduced into routine use; however, clear operational specifications for this process have been lacking. In August 2025, the International Committee for Standardization in Haematology (ICSH) published the Guidance on the Validation of Laboratory Developed Tests in Haemostasis,which provided detailed definitions, performance verification requirements, and implementation strategies for LDT in this field. This article interprets the key provisions of the guideline, aiming to assist laboratory managers and technical personnel in understanding and applying these recommendations effectively.

Key words: thrombosis and hemostasis, laboratory developed tests, validation, guideline

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