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

1   CLS Hemostasis and Thrombosis Center, University of California, Davis Health System, Sacramento, California
2   New York Presbyterian Hospital—Columbia, New York, New York
3   Hamin Pazhuhan Tis Institute, Tehran, Iran
Kieron Hickey
4   Sheffield Laboratory Medicine, Royal Hallamshire Hospital, Sheffield, United Kingdom
5   Section of Clinical Biochemistry and School of Medicine, University of Verona, Verona, Italy
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
8   CCS Northern Pathology Victoria, Melbourne, Australia
› Author Affiliations


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.

Publication History

Article published online:
15 November 2023

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