A Novel Approach for Glycosylated Hemoglobin Testing Using Microchip Affinity Electrophoresis

Area of Science:

• Biomedical Engineering
• Clinical Chemistry
• Point-of-Care Diagnostics

Background:

• Effective diabetes management relies on early diagnosis and long-term blood glucose control.
• Glycohemoglobin (HbA1 and HbA1c) are key biomarkers for diabetes assessment.
• Current diagnostic methods are costly, inaccessible, or inaccurate in specific patient populations.

Purpose of the Study:

• To develop and validate a novel point-of-care (POC) platform, HemeChip-GHb, for quantitative HbA1 detection.
• To address the need for accurate and affordable diabetes diagnostics, especially in resource-limited settings.

Main Methods:

• Design and development of the HemeChip-GHb system utilizing paper-based affinity electrophoresis.
• Testing of blood samples from healthy donors, prediabetic, and diabetic patients.
• Comparative analysis with the gold standard High-Performance Liquid Chromatography (HPLC) method.

Main Results:

• HemeChip-GHb demonstrated a high correlation (0.96) with HPLC for HbA1 levels.
• Bland-Altman analysis showed a minimal bias (-0.72%) between the methods.
• Error grid analysis indicated 99.6% of results fell within clinically acceptable zones.

Conclusions:

• The HemeChip-GHb platform achieves accurate diabetes status detection with 100% sensitivity and specificity.
• This novel POC device offers a promising solution for accessible and reliable diabetes diagnostics.