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CC BY-NC-ND 4.0 · Semin Thromb Hemost
DOI: 10.1055/s-0043-1776405
Review Article

International Council for Standardization in Haematology Guidance for New Lot Verification of Coagulation Reagents, Calibrators, and Controls

Robert C. Gosselin 
1   CLS Hemostasis and Thrombosis Center, University of California, Davis Health System, Sacramento, California
,
Donna Castellone 
2   New York Presbyterian Hospital—Columbia, New York, New York
,
Akbar Dorgalaleh 
3   Hamin Pazhuhan Tis Institute, Tehran, Iran
,
Kieron Hickey
4   Sheffield Laboratory Medicine, Royal Hallamshire Hospital, Sheffield, United Kingdom
,
Giuseppe Lippi 
5   Section of Clinical Biochemistry and School of Medicine, University of Verona, Verona, Italy
,
Karen Moffat 
6   Department of Pathology and Molecular Medicine, McMaster University, Hamilton Ontario, Canada
,
Rebecca O'Toole
7   Hematology Department, Wellington Hospital and Health Care, Wellington, New Zealand
,
Joe Rigano 
8   CCS Northern Pathology Victoria, Melbourne, Australia
› Author Affiliations
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Abstract

The clinical laboratory uses commercial products with limited shelf life or certain expiry dates requiring frequent lot changes. Prior to implementation for clinical use, laboratories should determine the performance of the new reagent lot to ensure that there is no significant shift in reagent performance or reporting of patient data. This guideline has been written on behalf of the International Council for Standardization in Haematology (ICSH) to provide the framework and provisional guidance for clinical laboratories for evaluating and verifying the performance of new lot reagents used for coagulation testing. These ICSH Working Party consensus recommendations are based on good laboratory practice, regulatory recommendations, evidence emerged from scientific publications, and expert opinion and are meant to supplement regional standards, regulations, or requirements.

Keywords

new lot reagent verification - coagulation testing - laboratory


Publication History

Article published online:
15 November 2023

© 2023. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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