Development of stabilizing hemoglobin A2 reference materials and assessment of commutability using multiple...

Area of Science:

• Clinical Chemistry
• Biotechnology
• Reference Material Development

Background:

• Developing stable and homogeneous hemoglobin A2 (HbA2) reference materials presents significant challenges.
• Accurate evaluation of commutability and appropriate statistical methods are critical for reliable clinical diagnostics.

Purpose of the Study:

• To develop and characterize two levels of HbA2 reference materials with enhanced stability and homogeneity.
• To evaluate the commutability of these HbA2 reference materials using multiple statistical models and routine analyzers.

Main Methods:

• A novel combined formulation buffer was developed to ensure material homogeneity and stability.
• Reference values, homogeneity, stability, and value transfer were determined following CLSI guidelines.
• Commutability was assessed on five routine analyzers using four statistical methods, including Passing-Bablok regression.

Main Results:

• The developed HbA2 reference materials exhibited concentrations of 2.13% ± 0.21% and 6.23% ± 0.48%.
• Materials demonstrated excellent homogeneity, stability (short- and long-term), and reliable value transfer.
• All routine analyzers showed compatibility, and Passing-Bablok regression was identified as a superior method for commutability assessment.

Conclusions:

• The new HbA2 reference materials offer good homogeneity, stability, and reliable value transfer.
• Passing-Bablok regression analysis is recommended for evaluating the commutability of HbA2 reference materials.
• These findings contribute to improved accuracy and reliability in HbA2 clinical measurements.