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

doi:10.1111/ijlh.13550

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

Int J Lab Hematol. 2021 Oct;43(5):907-916. doi: 10.1111/ijlh.13550. Epub 2021 Apr 20.

Authors

Chris Gardiner¹, Robyn Coleman², Moniek P M de Maat³, Akbar Dorgalaleh⁴, Marión Echenagucia⁵, Robert C Gosselin⁶, Masahiro Ieko⁷, Steve Kitchen⁸

Affiliations

¹ Haemostasis Research Unit, University College London, London, U.K.
² Department of Haematology, Sullivan Nicolaides Pathology, Bowen Hills, QLD, Australia.
³ Department of Haematology, Erasmus Medical Centre Rotterdam, Rotterdam, The Netherlands.
⁴ Department of Hematology and Blood Transfusion, School of Allied Medicine, Iran University of Medical Sciences, Tehran, Iran.
⁵ Centro Nacional de Hemofilia, Banco Municipal de Sangre del Distrito Capital, Caracas, Venezuela.
⁶ Thrombosis and Hemostasis Center, University of California, Davis Health System, Sacramento, CA, USA.
⁷ Department of Hematology/Clinical Laboratory, Iwate Prefectural Chubu Hospital, Kitakami, Japan.
⁸ Sheffield Haemophilia and Thrombosis Centre, Royal Hallamshire Hospital, Sheffield, U.K.

PMID: 33876567
DOI: 10.1111/ijlh.13550

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.

Keywords: assays; haemostasis; laboratory automation; precision.

Publication types

Review

MeSH terms

Animals
Anticoagulants / analysis
Blood Coagulation Factors / analysis
Calibration
Clinical Laboratory Services / standards
Fibrin Fibrinogen Degradation Products / analysis
Hematologic Tests / methods
Hematologic Tests / standards*
Hemostasis*
Humans
Reference Standards
Thrombophilia / blood
Thrombophilia / diagnosis

Substances

Anticoagulants
Blood Coagulation Factors
Fibrin Fibrinogen Degradation Products
fibrin fragment D