Developing a reference system for the IFCC standardization of HbA₂

Area of Science:

• Clinical Chemistry
• Hematology
• Biomedical Standardization

Background:

• Hemoglobin A2 (HbA2) is a key indicator for beta-thalassemia diagnosis.
• Clinical use of HbA2 cutoffs is limited by inter-method and inter-laboratory variability.

Purpose of the Study:

• To review the historical, current, and future aspects of HbA2 standardization.
• To describe the present status of HbA2 testing and its clinical implications.

Main Methods:

• Review of the IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) standardization program for HbA2 initiated in 2004.
• Development of a higher-order reference measurement procedure for HbA2.
• Preparation of a certified reference material in collaboration with the IRMM (Institute for Reference Materials and Measurements).

Main Results:

• Standardization efforts for HbA2 are ongoing.
• A complete reference system for HbA2 measurement is being developed.
• Improved standardization is expected to enhance the clinical utility of HbA2 testing.

Conclusions:

• Standardization of HbA2 testing is essential for reliable beta-thalassemia screening.
• The IFCC program is progressing towards establishing robust reference materials and methods.
• Future advancements will improve the accuracy and comparability of HbA2 results globally.