[Assessment of thromboplastins according to the WHO guidelines and the results of external quality control]

Area of Science:

• Clinical Chemistry
• Hematology
• Medical Diagnostics

Context:

• Thromboplastins are critical reagents for prothrombin time (PT) testing, a key measure of the extrinsic pathway of coagulation.
• Adherence to World Health Organization (WHO) guidelines is essential for ensuring the quality and comparability of thromboplastin reagents.
• External quality control programs play a vital role in monitoring laboratory performance and reagent consistency.

Purpose:

• To evaluate commercial thromboplastins for their compliance with established WHO guidelines.
• To validate the accuracy and reliability of prothrombin time test results obtained using these assessed thromboplastins.
• To confirm the consistency of international normalized ratio (INR) values derived from assessed thromboplastins within external quality control frameworks.

Summary:

• Commercial thromboplastins were assessed and found to comply with WHO guidelines.
• Over 5-8 years, participation in Russian and UK external quality control programs demonstrated that the international normalized ratio (INR) derived from these thromboplastins aligned with interlaboratory consensus values.
• The study confirms that properly assessed thromboplastins yield accurate prothrombin time determinations.

Impact:

• Ensures the reliability of PT/INR results used for monitoring anticoagulant therapy, such as warfarin.
• Contributes to standardization and harmonization of coagulation testing across different laboratories and geographical regions.
• Provides confidence in the performance of commercial thromboplastins, supporting accurate clinical decision-making.