International reference standards in coagulation

Area of Science:

• Biochemistry
• Hematology
• Laboratory Medicine

Background:

• Coagulation factor activity measurement is challenging due to the lack of absolute physico-chemical techniques.
• Estimation relies on comparative bioassays against reference standards, which can introduce variability.
• Inconsistent local reference standards lead to poor inter-laboratory agreement.

Purpose of the Study:

• To describe the principles, practices, and challenges of biological standardization for coagulation factor assays.
• To highlight the development and application of reference standards, particularly WHO International Standards.
• To emphasize the role of international standards in harmonizing laboratory measurements.

Main Methods:

• Review of principles and practices in biological standardization.
• Discussion of reference standard development and utilization for coagulation factor assays.
• Focus on World Health Organization (WHO) International Standards for plasma and concentrates.

Main Results:

• Variability in local reference standards hinders consistent laboratory results.
• International Standards from WHO provide a common calibration source, crucial for harmonization.
• WHO standards define the International Unit, enabling global measurement consistency.

Conclusions:

• Biological standardization is essential for accurate coagulation factor assays.
• World Health Organization (WHO) International Standards are vital for harmonizing measurements globally.
• Consistent use of international standards improves inter-laboratory agreement and reliability.