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.
Bibliographical noteFunding Information:
ICSH is a ?not for profit? organization. All authors were part of the ICSH coagulometer evaluation Working Group chaired by CG and all contributed to the design, drafting and editing of this document.
© 2021 John Wiley & Sons Ltd