ISO-based assessment of accuracy and precision of glucose meters in dogs

基于 ISO 的犬用血糖仪准确度和精密度评估

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作者:Y Brito-Casillas, P Figueirinhas, J C Wiebe, L López-Ríos, D Pérez-Barreto, C Melián, A M Wägner

Background

Portable blood glucose meters (PBGMs) allow easy glucose measurements. As animal-specific PBGMs are not available everywhere, those for humans are widely used. Objectives: To assess the accuracy and precision of 9 PBGMs in canine whole blood (WB) and plasma, based on the ISO 15197:2013. Animals: Fifty-nine client-owned dogs attending the Veterinary Teaching Hospital.

Methods

Analytical evaluation of 100 blood samples was performed for accuracy and 23 for precision (glucose 29-579 mg/dL) following ISO recommendations. A PBGM was considered accurate if 95% of the measurements were within ±15 mg/dL from the reference when glucose was <100 mg/dL and within ±15% when it was ≥100 mg/dL, and if 99% of them were within zones A and B in error grid analysis (EG). A hexokinase-based analyzer was used as reference. Ninety samples were assessed for hematocrit interferences.

Results

Accuracy requirements were not fulfilled by any PBGM in WB (74% of measurements within the limits for the most accurate) and by 1 only in plasma. However, the EG analysis in WB was passed by 6 PBGM and by all in plasma. The most accurate were also the most precise, with coefficients of variation <5% in WB and <3% in plasma. Hematocrit correlated with bias against the reference method in 4 PBGM (r = -0.243 - [-0.371]; P < .021). Conclusions and clinical importance: This disparity among PBGM suggests that meters approved for humans need to be evaluated before use in other species.

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