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

Introduction In previous studies abnormal HCT levels and medication were identified as possible causes of inaccurate reading with BGM in daily routine. The GLUCOCARD S onyx (ARKRAY Inc.) BGM was evaluated over the wide HCT range of 20-70% as well as its impact on 27 common drug interferences listed by the ISO15197:2013/EN ISO15197:2015 in comparison to clinical laboratory reference methods.Methods Pooled venous whole blood samples of > 200 study participants were prepared to represent 4 different HCT concentrations from 20-70% and 3 different glucose concentrations from 60-360 mg/dL. Those were spiked with 27 potential interfering substances and tested with GLUCOCARD S onyx, Atellica CH for D-Glucose and Sysmex XN-10 for HCT confirmation.Results Pooled venous whole blood at glucose concentrations (60 ± 6, 130 ± 13 and 360 ± 30 mg/dL) were statistically analyzed (Levene, one-way ANOVA). A stable performance meeting the ISO15197:2013 acceptance criteria at HCT concentrations of 20-25, 42 ± 2, 55 ± 2 and 66-69% was observed (p > 0,05). Furthermore, the 27 chemical substances did not show any significant difference (p > 0,05) among the averages, except for Ascorbic acid (>6 mg/dL), Sodium (>180 mmol/L) and Xylose (>600 mg/dL). Ascorbic acid at 3 mg/dL showed no more interference and Sodium at 90 mmol/L showed no interference anymore for normal to low glucose readings.Conclusion The GLUCOCARD S onyx BGM was evaluated under conditions equivalent to routine clinical practice as defined by ISO15197:2013. Correct glucose readings over a wide HCT range (20-70%) besides medication were obtained with GLUCOCARD S onyx, allowing patients to manage their diabetes with confidence and healthcare providers to treat diabetes in complex clinical scenarios.