Maltose interference-free test strips for blood glucose testing at point-of-care: a laboratory performance evaluation

Area of Science:

• Biomedical Engineering
• Clinical Chemistry

Background:

• Maltose interference poses a challenge for point-of-care blood glucose testing accuracy.
• A modified recombinant glucose dehydrogenase-pyrroloquinoline quinone system was developed to address maltose interference.

Purpose of the Study:

• To evaluate the performance of a new maltose interference-free test strip for the Accu-Chek Performa glucose meter.
• To assess the impact of various sugars, including maltose, on glucose testing results.

Main Methods:

• 120 blood specimens were analyzed for imprecision, linearity, and method comparison against a clinical laboratory standard.
• Two specimens were spiked with maltose, xylose, and galactose to evaluate sugar interference across different test strips.
• Performance was assessed using Clarke Error Grid analysis and Bland-Altman plots.

Main Results:

• The modified Performa test strips demonstrated high precision (CV < 7%) and excellent correlation with laboratory results (Spearman's r² = 0.960).
• Maltose and xylose did not interfere with glucose measurements, while galactose showed some interference.
• 99% of results met ISO 15197:2003 performance criteria, indicating high accuracy.

Conclusions:

• The modified Accu-Chek Performa test strips effectively eliminate maltose and xylose interference.
• These test strips meet stringent ISO 15197:2003 standards, providing reliable glucose measurements.
• The study confirms the suitability of these improved test strips for accurate point-of-care glucose monitoring.