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Related Experiment Videos

Calibration verification of the International Normalized Ratio

G C Critchfield1, S T Bennett, W R Swaim

  • 1Corning Clinical Laboratories, Teterboro, New Jersey, USA.

American Journal of Clinical Pathology
|December 1, 1996
PubMed
Summary

Laboratories can now locally verify the accuracy of their International Normalized Ratio (INR) results using a new method with standard plasmas. This approach helps ensure reliable prothrombin time reporting across different testing systems.

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Area of Science:

  • Clinical Chemistry
  • Hematology
  • Laboratory Medicine

Background:

  • The International Normalized Ratio (INR) system aims to standardize prothrombin time (PT) reporting across diverse reagent and instrument platforms.
  • Complete standardization is hindered by inaccurate International Sensitivity Index (ISI) assignments and local reagent/instrument variations.
  • Currently, laboratories lack an easy method to independently verify the accuracy of their INR measurements.

Purpose of the Study:

  • To present a novel method enabling individual laboratories to locally verify the accuracy of their INR results.
  • To demonstrate a practical approach for assessing the reportable range of INR accuracy within a laboratory setting.

Main Methods:

  • Utilized standard lyophilized plasmas with INR values calibrated against the International Reference Preparation (IRP) RBT/90 rabbit thromboplastin.

Related Experiment Videos

  • Illustrated the method on a single coagulometer using two thromboplastin lots with different ISI values (1.20 and 1.97).

    • Main Results:

    • The developed method allows for the local establishment of a reportable accuracy range for INR measurements at a defined error tolerance.
    • Demonstrated superior accuracy with Thromboplastin-DS (ISI 1.20) compared to Thromboplastin-D (ISI 1.97) in the illustrated example.
    • The method is applicable to laboratories of all sizes for calibration verification of INR reagent/instrument systems.

    Conclusions:

    • This method empowers laboratories to perform essential calibration verification for their INR testing systems.
    • Implementing this alongside precision assessments can aid in selecting superior reagent/instrument systems.
    • Ultimately, this leads to more accurate and clinically relevant INR results, improving patient care.