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Thromboplastin standards.

A M H P van den Besselaar¹, V Chantarangkul, A Tripodi

¹Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands. a.m.h.p.van_den_besselaar@lumc.nl

Biologicals : Journal of the International Association of Biological Standardization

|March 27, 2010

Summary

The Prothrombin Time (PT) test, reported as International Normalized Ratio (INR), requires precise calibration using International Standards. Proper calibration reduces variability in monitoring Vitamin K-antagonist therapy and managing liver disease patients.

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Area of Science:

Clinical Chemistry
Hematology
Medical Diagnostics

Background:

The Prothrombin Time (PT) test is crucial for monitoring Vitamin K-antagonist (VKA) therapy.
Results are standardized as the International Normalized Ratio (INR) using International Standards (IS) for thromboplastin.
Accurate INR calculation relies on robust calibration models.

Purpose of the Study:

To outline the calibration process for new PT test systems.
To ensure accurate INR reporting for VKA monitoring and chronic liver disease management.
To minimize between-laboratory variations in PT/INR measurements.

Main Methods:

Calibration involves using appropriate IS and plasma samples from healthy volunteers and VKA-treated patients.
A linear relationship between log(PT) values from the new system and the reference IS is assumed.
Patient samples are selected within a 1.5-4.5 INR range, and outliers are rejected based on residual standard deviations.

Main Results:

The described calibration method aims to reduce between-laboratory variation.
Proper calibration is essential for reliable PT/INR results.
Specific protocols for sample selection and outlier rejection enhance calibration accuracy.

Conclusions:

Accurate calibration of PT test systems is vital for effective VKA monitoring.
The PT test, when properly calibrated, is also valuable for managing chronic liver disease.
Standardized calibration procedures ensure consistency and reliability in diagnostic testing.