Haemostasis Research Unit, University College London, London, U.K.
Department of Haematology, Sullivan Nicolaides Pathology, Bowen Hills, QLD, Australia.
Int J Lab Hematol. 2021 Oct;43(5):907-916. doi: 10.1111/ijlh.13550. Epub 2021 Apr 20.
Before a new method is used for clinical testing, it is essential that it is evaluated for suitability for its intended purpose. This document gives guidance for the performance, verification and implementation processes required by regulatory and accreditation bodies. It covers the planning and verification of specialist haemostatic tests, including factor assays, D-dimers, direct anticoagulants and thrombophilia testing.
在将新方法用于临床检测之前，必须评估其是否适合预期用途。本文档为监管和认证机构所需的性能、验证和实施过程提供指导。它涵盖了包括因子测定、D-二聚体、直接抗凝剂和血栓形成倾向检测在内的专业止血测试的规划和验证。
