血栓与止血检验在出血性及血栓性疾病的诊断、治疗和监测中发挥关键作用，由于专业特点和临床需求，实验室内会不同程度开展一些实验室自行开发检测项目（LDT）。LDT在进入临床应用之前需要确认性能满足临床需求，但是缺乏明确的操作规范。2025年8月，国际血液学标准化委员会（ICSH）《血栓与止血实验室自行开发检测项目性能确认指南》，对血栓与止血实验室中LDT的定义、性能确认要求、实施方法等做了详细规定。本文对该指南的重点条款进行解读，旨在帮助实验室管理者和技术人员理解并实施。

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.