New ICSH guidance for internal quality control policy for blood cell counters

January 2024

The International Council for Standardisation in Haematology is pleased to announce the publication of a new ICSH guidance for internal quality control policy for blood cell counters.

Contributors

Richard McCafferty  |  George Cembrowski  |  Barbara de la Salle  | Mingting Peng  |  Eloisa Urrechaga

Abstract: This paper is a description of the ICSH guidance for internal quality control (IQC)policy for blood cell counters. It follows from and links to a separate ICSH review for such policies and practices.

The ICSH has gathered information regarding the current state of practice through review of published guidance from regulatory bodies, a questionnaire to six major cell counter manufacturers and a survey issued to 191 diagnostic laboratories in four countries (China, the Republic of Ireland,Spain, and the United Kingdom) on their IQC practice and approach to the use of commercial IQC materials. This has revealed diversity both in guidance and in practice around the world. There is diversity in guidance from regulatory organizations in regard to IQC methods each recommends, clinical levels to use and frequency to run commercial controls, and finally recommended sources of commercial control materials.

The diversity in practice among clinical laboratories spans the areas of IQC methods used, derivation of target values, and action limits used with commercial control materials, and frequency of running commercial controls materials. These findings and their implications for IQC Practice are addressed in this guidance document, which proposes a harmonized approach to address the issues faced by diagnostic laboratories

....continue reading at Wiley Online Library - https://onlinelibrary.wiley.com/doi/epdf/10.1111/ijlh.14212

First published: January 2024

The publication is available to:

• View here - https://onlinelibrary.wiley.com/doi/epdf/10.1111/ijlh.14212

• DOI - https://doi.org/10.1111/ijlh.14212

ISSN - 1751-5521

eISSN - 1751-553X

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:

• View here - https://onlinelibrary.wiley.com/doi/abs/10.1111/ijlh.14209

• DOI - https://doi.org/10.1111/ijlh.14209

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.

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Published

First published: 20 November 2023

The publication is available to:

• View here - https://onlinelibrary.wiley.com/doi/full/10.1111/ijlh.14201

• PDF - https://onlinelibrary.wiley.com/doi/epdf/10.1111/ijlh.14201

ISSN: 1751-5521

eISSN: 1751-553X