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