New HPLC instrument performance evaluation in HbA_1c determination and comparison with capillary electrophoresis

Area of Science:

• Clinical Chemistry
• Analytical Biochemistry
• Diabetes Diagnostics

Background:

• Glycated hemoglobin (HbA1c) is a critical marker for assessing long-term glycemic control in diabetes mellitus.
• Accurate HbA1c measurement is essential for effective diabetes management and clinical outcome prediction in both type 1 and type 2 diabetes.
• Current routine HbA1c analysis employs methods including ion-exchange chromatography, affinity chromatography, capillary electrophoresis, immunoassay, and enzymatic assays.

Purpose of the Study:

• To evaluate the analytical performance of a novel HPLC instrument, the Tosoh HLC-723 G11 (VAR mode), for HbA1c determination.
• To compare the performance of the Tosoh HLC-723 G11 with a capillary electrophoresis system (Sebia Capillarys 2 Flex Piercing).

Main Methods:

• Analytical performance evaluation of the Tosoh HLC-723 G11, including reproducibility and linearity assessments.
• Parallel HbA1c analysis of 250 patient samples (healthy and diabetic) using both the Tosoh HLC-723 G11 and the Sebia Capillarys 2FP.
• Statistical comparison of results obtained from the two analytical platforms.

Main Results:

• The Tosoh HLC-723 G11 demonstrated excellent reproducibility (%CV < 2%) over 10 days for quality controls and patient samples.
• Excellent linearity was observed for HbA1c values across a wide analytical range (3.5% to 18.5%), with R² = 1.
• A strong correlation (r = 0.99) was found between the Tosoh HLC-723 G11 and Capillarys 2FP, though systematic differences were noted at low and high HbA1c concentrations.

Conclusions:

• The Tosoh HLC-723 G11 exhibits robust repeatability, reproducibility, and accuracy for HbA1c measurement.
• The instrument's automated simplicity makes it well-suited for routine use in clinical chemistry laboratories.
• The Tosoh HLC-723 G11 is a viable option for reliable HbA1c analysis in diabetes monitoring.