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.

Authors & Contributors

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

Published In

International Journal of Laboratory Hematology. 2021; Volume 43: 907-916

First Published

20 April 2021

Publisher

Wiley

DOI

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.

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