Haemostasis Research Unit, University College London, London, UK.
Department of Haematology, Sullivan Nicolaides Pathology, Bowen Hills, QLD, Australia.
Int J Lab Hematol. 2021 Apr;43(2):169-183. doi: 10.1111/ijlh.13411. Epub 2020 Nov 29.
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 of verification, validation and implementation processes required by regulatory and accreditation bodies. It covers the planning and execution of an evaluation of the commonly performed screening tests (prothrombin time, activated partial thromboplastin time, thrombin time and fibrinogen assay), and instrument-specific issues. Advice on selecting an appropriate haemostasis analyser, planning the evaluation, and assessing the reference, interval, precision, accuracy, and comparability of a haemostasis test system are also given. A second companion document will cover specialist haemostasis testing.
在将新方法用于临床检测之前，必须对其是否适合预期用途进行评估。本文件为监管和认证机构所需的验证、确认和实施过程的执行提供了指导。它涵盖了对常见筛查测试（凝血酶原时间、活化部分凝血活酶时间、凝血酶时间和纤维蛋白原测定）以及仪器特定问题的评估的规划和执行。还就如何选择合适的止血分析仪、规划评估以及评估止血测试系统的参考值、区间、精密度、准确度和可比性提供了建议。第二份配套文件将涵盖专业的止血测试。
