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Report of the International Council for Standardization in Haematology working group for standardization of reticulocyte parameters


December 2023


The International Council for Standardisation in Haematology is pleased to announce the publication of a new report of the ICSH working group for Standardization of Reticulocyte Parameters

The ICSH Working Group Contributors


Amrom E. Obstfeld | Bruce H. Davis | Jin-Yeong Han | Eloisa Urrechaga


Abstract


Introduction: The International Council for Standardization in Haematology

convened a working group to assess and propose improvements upon the state of

standardization and harmonization of reticulocyte parameters among commercial

hematology analyzers.


Methods: An international group of laboratory hematologists prospectively collected

and analyzed clinical samples using locally available IVD commercial hematology analyzers. Eight hundred and fifty-five total samples were collected at 6 sites using 9 distinct analyzer types. Samples were assessed for reticulocyte percent (RET%),

immature reticulocyte fraction (IRF), and reticulocyte hemoglobin content (RHC).

Method comparison and regression statistics were calculated. These analyses were

used to determine whether statistical recalibration offered a potential avenue for

increasing comparability between these methods.


Results: While methods producing reticulocyte percent were the most comparable in

this study, the state of harmonization for the IRF and RHC was reduced with pearson

correlation coefficients ranging from 0.955 to 0.77 and 0.927 and 0.680, respectively. Nevertheless, use of parameters from the Passing Bablok regression substantially improved the comparability of the results. In addition, precision data was

derived which also demonstrated substantial differences between analyzer systems.


Conclusion: While reticulocyte counting is correlated between the automated

methods evaluated in this study, the current state of harmonization of other reticulocyte parameters is not as strong. A major challenge in moving this field forward is the

need for commutable materials to facilitate comparisons between analyzers not

co-located. A potential alternate approach to improve the current state would be

instrument re-calibration. However, this is challenging both technically and due to

national regulatory frameworks.


....continue reading at Wiley Online Library - https://onlinelibrary.wiley.com/doi/abs/10.1111/ijlh.14209


First published: 06 December 2023


The publication is available to:




NEW ICSH recommendations on fibrinogen assays, thrombin clotting time and related tests....


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

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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