International Council for Standardization in Haematology (ICSH) laboratory guidance for the verification of haemostasis analyser-reagent test systems. Part 2: Specialist tests and calibrated assays

Chris Gardiner*, Robyn Coleman, Moniek P.M. de Maat, Akbar Dorgalaleh, Marión Echenagucia, Robert C. Gosselin, Masahiro Ieko, Steve Kitchen

*Corresponding author for this work

Research output: Contribution to journalReview articleAcademicpeer-review

5 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)907-916
Number of pages10
JournalInternational Journal of Laboratory Hematology
Volume43
Issue number5
Early online date20 Apr 2021
DOIs
Publication statusPublished - Oct 2021

Bibliographical note

Funding 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.

Publisher Copyright:
© 2021 John Wiley & Sons Ltd

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