Hematocrit and drug interference study of the new Arkray Glucocard S Onyx blood glucose meter meeting ISO 15197:2013 accuracy criteria - a contribution to patient safety.

Abstract

Introduction: Abnormal HCT levels and medications can cause inaccurate readings with blood glucose meters (BGM) in routine practice. The GLUCOCARD S onyx (ARKRAY Inc.) BGM was evaluated over a wide HCT range (20-70%) and its interaction with 27 common drug interferences, as per ISO15197:2013/EN ISO15197:2015, compared to clinical laboratory reference methods.

Methods: Pooled venous blood samples from >200 participants were prepared with four HCT concentrations (20-70%) and three glucose concentrations (60-360 mg/dL). These were spiked with 27 potential interfering substances and tested using GLUCOCARD S onyx, Atellica CH (D-Glucose), and Sysmex XN-10 (HCT).

Results: Stable performance meeting ISO15197:2013 criteria were observed at HCT concentrations of 20-25%, 42±2%, 55±2%, and 66-69% (Levene, one-way ANOVA, p>0.05). No significant differences in averages were found for most substances, except for Ascorbic acid (>6 mg/dL), Sodium (>180 mmol/L), and Xylose (>600 mg/dL). Ascorbic acid at 3 mg/dL and Sodium at 90 mmol/L showed no interference for normal to low glucose readings.  .

Conclusion: The GLUCOCARD S onyx BGM provided accurate glucose readings across a wide HCT range (20-70%) and under various medication conditions, enabling reliable diabetes management by patients and effective treatment by healthcare providers in complex clinical scenarios.