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Related Experiment Videos

Standard for human thrombin.

I Robertson, P J Gaffney, D R Bangham

    Thrombosis Et Diathesis Haemorrhagica
    |September 30, 1975
    PubMed
    Summary
    This summary is machine-generated.

    A freeze-dried preparation (70/157) is suitable as an international standard for human thrombin assays. This stable thrombin standard demonstrated minimal potency loss over ten years, ensuring reliable clotting time tests.

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    Area of Science:

    • Biochemistry
    • Hematology
    • Clinical Chemistry

    Background:

    • Accurate quantification of thrombin activity is crucial for diagnosing and managing hemostatic disorders.
    • Standardization of thrombin assays is essential for inter-laboratory reproducibility and reliable clinical interpretation.
    • Existing thrombin standards may lack sufficient characterization or long-term stability.

    Purpose of the Study:

    • To evaluate the suitability of a freeze-dried preparation (coded 70/157) as an international standard for human thrombin.
    • To assess the stability and potency of the proposed thrombin standard under recommended storage conditions.
    • To establish a defined unit of thrombin activity based on the proposed standard.

    Main Methods:

    • An international collaborative study involving ten laboratories.

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  • Clotting time tests were employed to assess thrombin activity and compare preparations.
  • Stability testing was conducted over a ten-year period under specified storage conditions (-20°C in the dark).

    • Main Results:

    • The freeze-dried preparation (70/157) was deemed suitable for assaying human and bovine thrombin.
    • Assay variation within laboratories was significantly lower than between laboratories, indicating good reproducibility.
    • The preparation exhibited excellent stability, with a negligible estimated loss of potency over ten years.
    • Each ampoule was assigned a potency of 100 units, with one unit defined as the activity in 0.0853 mg of the preparation.

    Conclusions:

    • The thrombin preparation coded 70/157 is suitable to serve as an international standard for human thrombin.
    • The established standard provides a reliable basis for consistent and accurate thrombin activity measurements.
    • The findings were endorsed by study participants and the International Committee on Thrombosis and Haemostasis.