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New ICSH Guidance for New Lot Verification of Coagulation Reagents, Calibrators, and Controls


November 2023


ICSH, the International Council for Standardization in Haematology is pleased to announce the Publication of a new ICSH Guideline for New Lot Verification of Coagulation Reagents, Calibrators, and Controls


Authors


Robert C. Gosselin, CLS, Donna Castellone, MS, MASCP, MT (ASCP) SH, Akbar Dorgalaleh, PhD, Kieron Hickey, Giuseppe Lippi, MD, Karen Moffat, BEd, MSc, ART, FCSMLS(D), Rebecca O’Toole, MSc, Joe Rigano, BAppSci (MLS) (Dis), FAIMS


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.



Published


First published: 15 November 2023


By Thieme


The publication is available to:

ISSN 0094-6176


 

ABOUT ICSH


The International Council for Standardization in Haematology (ICSH) was initiated as a standardization committee by the European Society of Haematology (ESH) in 1963 and officially constituted by the International Society of Hematology (ISH) and the ESH in Stockholm in 1964.


​The ICSH is a not-for-profit non-governmental organisation that aims to achieve reliable and reproducible results in laboratory analysis in the field of diagnostic haematology.


​The ICSH coordinates Working Groups of experts to examine laboratory methods and instruments for haematological analyses, to deliberate on issues of standardization and to stimulate and coordinate scientific work as necessary towards the development of international standardization materials and guidelines.



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