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

被引:0
|
作者
Burrini, Claudio [1 ]
Morrocchi, Beatrice [1 ]
Giorgetti, Nicola [2 ]
Saeger, Beate [3 ]
机构
[1] Manfredo Fanfani Lifenet Healthcare Grp, Lab Clin Chem, Florence, Italy
[2] ARKRAY Italia SRL, Vimercate, MB, Italy
[3] ARKRAY Europe BV, Sci Affairs Div, Amstelveen, Netherlands
关键词
Hematocrit (HCT); drug interference testing; ISO 15197:2013/EN ISO 15197:2015 guidelines (ISO); accuracy; self-monitoring; blood glucose meter (BGM); GLUCOCARD S onyx (S onyx); reference method; DIALYSIS;
D O I
10.1080/17434440.2025.2470295
中图分类号
R318 [生物医学工程];
学科分类号
0831 ;
摘要
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.
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