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An international collaborative study establishing a reference preparation for Antithrombin III

T B Kirkwood, T W Barrowcliffe, D P Thomas

    Thrombosis and Haemostasis
    |February 29, 1980
    PubMed
    Summary

    A global study established a freeze-dried normal plasma as the International Reference Preparation for antithrombin III (At III). This reference material minimizes laboratory and method variations in At III assays.

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    Area of Science:

    • Biochemistry
    • Clinical Chemistry
    • Hematology

    Background:

    • Accurate quantification of antithrombin III (At III) is crucial for clinical diagnostics and therapeutic monitoring.
    • Existing reference materials for At III exhibited significant inter-laboratory and inter-method variability.

    Purpose of the Study:

    • To establish a stable and reliable international reference preparation for antithrombin III (At III).
    • To reduce variability in At III measurements across different laboratories and assay methodologies.

    Main Methods:

    • An international collaborative study involving 12 laboratories across 7 countries.
    • Measurement of At III in purified preparations and freeze-dried normal plasma using clotting, immunological, and amidolytic assays.
    • Statistical analysis of 105 valid assay results to assess inter-laboratory and inter-method variation.

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    Main Results:

    • Freeze-dried normal plasma demonstrated significantly less laboratory-to-laboratory and method-to-method variation compared to purified At III preparations.
    • Heparin co-factor activity assays on purified preparations yielded approximately half the At III levels detected by immunoassay or progressive clotting assays.
    • Excellent agreement among laboratories was achieved when using freeze-dried plasma for At III measurement across all assay types.

    Conclusions:

    • Freeze-dried normal plasma is a suitable matrix for an International Reference Preparation for antithrombin III (At III).
    • The World Health Organization established this material as the International Reference Preparation for At III with a potency of 0.9 IU/mL.
    • This reference preparation is expected to improve the standardization and reliability of At III assays globally.