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November 2023


ICSH, the International Council for Standardisation in Haematology is pleased to announce the publication of new ICSH Recommendations on fibrinogen assays, thrombin clotting time and related tests in the investigation of bleeding disorders.


Authors


Ian Mackie, Alessandro Casini, Marlien Pieters, Rajiv Pruthi, Chris Reilly-Stitt, Atsuo Suzuki


Abstract


This guidance was prepared on behalf of the International Council for Standardisation in Haematology (ICSH) by an international working group of clinicians and scientists.


The document focuses on tests and assays used for the assessment of fibrinogen function, particularly in the scenario of bleeding disorders. Thrombin clotting time (TT) is used as a screening test in some laboratories and also has some utility when direct anticoagulants are in use. The Clauss fibrinogen assay remains the method of choice for the assessment of fibrinogen function, but there are some situations where the results may be misleading. Prothrombin time derived fibrinogen assays are frequently used, but should be interpreted with caution; the results are not interchangeable between different methods and fibrinogen can be overestimated in certain clinical scenarios. Viscoelastic point of care methods may be helpful in emergency situations, while Reptilase time (and similar tests) are useful combined with TT in distinguishing heparin contamination of samples (i.e., if an incorrect blood draw is suspected) and the presence of direct thrombin inhibitors. Fibrinogen antigen assays should be used in the investigation of functional fibrinogen abnormalities; fibrinogen antigen and genetic testing are recommended in the confirmation of congenital fibrinogen disorders. The following recommendations for fibrinogen function assessment are based on published literature and expert opinion and should supplement local regulations and standards.


....continue reading at Wiley Online Library - here - https://onlinelibrary.wiley.com/doi/full/10.1111/ijlh.14201


Published


First published: 20 November 2023


The publication is available to:

ISSN: 1751-5521

eISSN: 1751-553X


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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July 2023


ICSH, the International Council for Standardization in Haematology is pleased to announce the Publication of a new ICSH Guideline for laboratory measurement of factor VIII and factor IX type I inhibitors.


Author Contributions


Piet Meijer: Drafting manuscript.


Flora Peyvandi, Guy Young, Rajiv Pruthi, Simara de Lima Montalvao and Steve Kitchen critically reviewed, edited and approved the final manuscript.


Abstract


Prepared on behalf of the International Council for Standardisation in Haematology, the aim of the document is to provide guidance and recommendations on the measurement of factor VIII (FVIII) and factorIX (FIX) inhibitors.


After an introduction on the clinical background and relevance of factor VIII and factor IX inhibitor testing, the following aspects of laboratory testing are included: screening for inhibitors, assay principle, sample requirements, testing requirements and interpretation, quality assurance, interferences and recent developments.


This guidance document focusses on recommendations for a standardised procedure for the laboratory measurement of FVIII and FIX type I inhibitors.


The recommendations are based on published data in peer-reviewed literature and expert opinion.


Published


First published: 07 June 2023


By the International Journal of Laboratory Hematology Volume 45, Issue 4 Aug 2023 Pages i-iv, 405-619


The publication is available to:


 

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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