Hamostaseologie 2025; 45(S 01): S30
DOI: 10.1055/s-0044-1801587
Abstracts
Topics
T-06 Diagnostics and laboratory tests

Clinical laboratories need more information about commercially available reagents to prepare to IVDR: A call from ICSH

Authors

  • D Lasne

    2   AP-HP, Hôpital Universitaire Necker-Enfants Malades, Paris, France, Haematology Laboratory, Paris, France

  • S Testa

    3   Cremona Hospital, Cremona, Italy, Haemostasis and Thrombosis Centre, Cremona, Italy

  • S Kitchen

    4   Sheffield Haemophilia and Thrombosis Centre, Sheffield Haemophilia and Thrombosis Centre, Sheffield, UK

  • C Gardiner

    5   St James University Hospital, Leeds Teaching Hospitals NHS Trust, Laboratory Medicine, Leeds, UK

  • P Meier

    6   ECAT Foundation (External Quality Control for Assays and Tests), Leiden, Netherlands

  • F Mullier

    1   Université catholique de Louvain, CHU UCL NAMUR, Namur Thrombosis and Hemostasis Center, Yvoir, Belgium
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    Introduction: According to the new In Vitro Diagnostic Medical Device Regulation (EU) (IVDR) an In Vitro Medical Device (IVD) is considered as laboratory developed test (LDTs) if used outside of intended use. It is therefore essential that the information given about the intended use is clear, precise and well documented. For now, the only source of information on the intended use for laboratories is the instruction for use (IFU). The primary aim of this study was to analyse and compare the intended uses information and clinical performances provided by several manufacturers for a large panel of coagulation assays. The secondary objective was to provide a list of minimum information that must be accessible to clinical laboratories.

    Method: We analyzed 195 IFU for the main assays used in European haemostasis clinical laboratories and commercialized by 12 manufacturers.

    Results: The "intended use" section appears in almost all IFU, but the information given in this section is very heterogeneous. The versions of the IFU dated from 2012 to April 2024. We observed disagreement about the intended uses provided for each of the assays assessed with some intended uses not supported by guidance or guidelines. Some indications are used in clinical laboratories but are not provided by the manufacturers. We only found information on clinical performance for the following assays: D-dimers, DRVVT, Anti-Cardiolipin, Anti-β2 Glycoprotein-I, HIT with sometimes limited information. For some assays data are available in the literature including guidelines but are not reported in IFU (TT, Anti-Xa, anti-IIa, PC, VWF, ADAMTS13 activity and HIT). Moreover, the matrix is only reported for some tests (HIT, anti-Cardiolipin IgG and IgM, Anti-β2 Glycoprotein-I IgG). The importance of a pre-test probability is not systematically mentioned or with too limited information in the IFU for several assays where this would be relevant (D-dimer, HIT, ADAMTS13 activity).

    Conclusion: We urgently call for access to the necessary information to know the intended use of a reagent according to the IVDR. We define the minimum information that should be available to laboratories. This improvement is a mandatory step before the definition of LDTs.


     

    Conflict of Interest:

    None

    Publikationsverlauf

    Artikel online veröffentlicht:
    13. Februar 2025

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