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Related Experiment Videos

Highly sensitive thromboplastins do not improve INR precision

V L Ng1, R Valdes-Camin, E L Gottfried

  • 1Department of Laboratory Medicine, School of Medicine, University of California San Francisco, and San Francisco General Hospital, 94110, USA.

American Journal of Clinical Pathology
|March 12, 1998
PubMed
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Highly sensitive thromboplastin reagents do not guarantee consistent International Normalized Ratio (INR) results. This study found significant variability, questioning the current INR standardization for oral anticoagulant therapy.

Area of Science:

  • Clinical Chemistry
  • Hematology
  • Medical Diagnostics

Background:

  • The International Normalized Ratio (INR) system aims to standardize prothrombin time (PT) for oral anticoagulant therapy.
  • Highly sensitive thromboplastin reagents with an International Sensitivity Index (ISI) ≤ 1.2 are recommended to minimize interlaboratory variability.

Purpose of the Study:

  • To evaluate the consistency of INR values obtained using "highly sensitive" thromboplastin reagents and automated analyzers.
  • To determine if current INR measurement methods achieve standardization goals.

Main Methods:

  • Compared INR values from 69 patient specimens using four thromboplastin preparations (ISI 0.96-1.10) on two automated photo-optical analyzers.
  • Utilized multivariate analysis on 552 INR values to assess reagent-coagulometer combinations and normalization.

Related Experiment Videos

  • Assessed clinical significance of INR differences by categorizing values into therapeutic ranges.
  • Main Results:

    • Eight reagent-coagulometer combinations did not yield equivalent INR values.
    • INR values were not normalized even with local ISI assignments.
    • Significant discordance (17%-29%) in paired thromboplastin values occurred across therapeutic categories.

    Conclusions:

    • The current INR system, even with highly sensitive reagents, fails to achieve standardized prothrombin time values.
    • The recommendation to exclusively use highly sensitive reagents for oral anticoagulant therapy regulation is not supported by these findings.