[Evaluation of D10 hemoglobin testing system for hemoglobin A1C assay]

Area of Science:

• Clinical Chemistry
• Hematology
• Analytical Biochemistry

Background:

• Accurate hemoglobin A1C (HbA1C) measurement is crucial for diabetes mellitus management.
• Evaluating new analytical systems is essential for improving diagnostic efficiency and patient care.

Purpose of the Study:

• To assess the analytical performance and practicability of the Bio-Rad D10 system for HbA1C testing.
• To compare the D10 system's results with a established method, the Bio-Rad Variant II.

Main Methods:

• Evaluation of analytical qualities including imprecision, correlation, measuring range, and interference.
• Assessment of practicability and detection capabilities for common hemoglobin variants.
• Utilized High-Performance Liquid Chromatography (HPLC) methodology.

Main Results:

• Satisfactory analytical qualities with good imprecision (within-run CVs ≤ 0.63%, between-run CVs ≤ 1.16%).
• Excellent correlation with Bio-Rad Variant II (r = 0.998) and good agreement for HbA1C < 15%.
• No interference from common substances and ability to detect HbS, C, D, E, O variants, with flexible programming.

Conclusions:

• The Bio-Rad D10 system demonstrates accurate HbA1C quantification, certified by NGSP.
• Its ease of use, variant detection, and reliable performance make it a valuable tool for clinical laboratories.
• The system offers a practical and efficient solution for HbA1C determination in various patient groups.