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

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

Hematology

Research output: Contribution to journal › Review article › Academic › peer-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 language	English
Pages (from-to)	907-916
Number of pages	10
Journal	International Journal of Laboratory Hematology
Volume	43
Issue number	5
Early online date	20 Apr 2021
DOIs	https://doi.org/10.1111/ijlh.13550
Publication status	Published - 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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10.1111/ijlh.13550

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Gardiner, C., Coleman, R., de Maat, M. P. M., Dorgalaleh, A., Echenagucia, M., Gosselin, R. C., Ieko, M., & Kitchen, S. (2021). 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. International Journal of Laboratory Hematology, 43(5), 907-916. https://doi.org/10.1111/ijlh.13550

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title = "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",

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.",

author = "Chris Gardiner and Robyn Coleman and {de Maat}, {Moniek P.M.} and Akbar Dorgalaleh and Mari{\'o}n Echenagucia and Gosselin, {Robert C.} and Masahiro Ieko and Steve Kitchen",

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: {\textcopyright} 2021 John Wiley & Sons Ltd",

year = "2021",

month = oct,

doi = "10.1111/ijlh.13550",

language = "English",

volume = "43",

pages = "907--916",

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Gardiner, C, Coleman, R, de Maat, MPM, Dorgalaleh, A, Echenagucia, M, Gosselin, RC, Ieko, M & Kitchen, S 2021, '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', International Journal of Laboratory Hematology, vol. 43, no. 5, pp. 907-916. https://doi.org/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. / Gardiner, Chris; Coleman, Robyn; de Maat, Moniek P.M. et al.

In: International Journal of Laboratory Hematology, Vol. 43, No. 5, 10.2021, p. 907-916.

Research output: Contribution to journal › Review article › Academic › peer-review

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T2 - Specialist tests and calibrated assays

AU - Gardiner, Chris

AU - Coleman, Robyn

AU - de Maat, Moniek P.M.

AU - Dorgalaleh, Akbar

AU - Echenagucia, Marión

AU - Gosselin, Robert C.

AU - Ieko, Masahiro

AU - Kitchen, Steve

N1 - 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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N2 - 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.

AB - 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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DO - 10.1111/ijlh.13550

M3 - Review article

C2 - 33876567

AN - SCOPUS:85104439594

VL - 43

SP - 907

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JO - International Journal of Laboratory Hematology

JF - International Journal of Laboratory Hematology

SN - 1751-5521

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ER -

Gardiner C, Coleman R, de Maat MPM, Dorgalaleh A, Echenagucia M, Gosselin RC et al. 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. International Journal of Laboratory Hematology. 2021 Oct;43(5):907-916. Epub 2021 Apr 20. 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

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