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Performance of the Ascensia ENTRUST glucose meter for determination of blood glucose concentration in rats
Authors:S. Vijayakumar  Nancy E. Everds  P. Kalaiselvan  R.K. Shakthidevan  Yogesh Kumar V. Murkunde  Monique Y. Wells
Affiliation:1. Department of Pathology, International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India;2. Amgen Inc., Seattle, WA, USA;3. Toxicology/Pathology Services Inc., Paris, France
Abstract:Background: The Ascensia ENTRUST blood glucose meter is intended for self‐monitoring of blood glucose by diabetic patients. Use of such a glucometer would minimize blood volume requirements for the measurement of glucose in small laboratory animals. Objective: The purpose of this study was to assess the performance of the Ascensia ENTRUST for measuring glucose in whole blood from Wistar rats by evaluating the effect of anticoagulant and sample processing delay and comparing normalized results with plasma glucose concentration. Methods: Blood samples were collected from the retroorbital sinus of 30 male Wistar rats with a wide range of blood glucose concentrations. Glucose concentration was measured with the Ascensia ENTRUST in nonheparinized (NH) and heparinized samples immediately after collection (Hep‐0) and in heparinized samples after a 15 min delay at 23–28°C (Hep‐15). Heparinized samples were centrifuged and glucose concentration was determined in plasma using an automated chemistry analyzer. Results were compared to assess the effect of anticoagulant (NH vs Hep‐0) and time (Hep 0 vs Hep 15), and to compare normalized Hep‐15 results with plasma glucose concentration. Results: Glucose concentration was not significantly different between NH and Hep‐0 samples. Glucose concentration was lower in Hep‐15 (77±36.9 mg/dL) than Hep‐0 (88±39.7 mg/dL) samples, but the difference was not significant. With normalization, Hep‐15 glucose concentration correlated well (r≥.98) with plasma glucose concentration but was lower by 6.0±16.7 mg/dL, with a positive bias at low glucose concentrations and a negative bias at high concentrations. Conclusion: The Ascensia ENTRUST may be adequate for repeated blood glucose measurements in rats, but its results do not accurately predict plasma glucose concentrations measured by an automated clinical chemistry analyzer.
Keywords:Blood glucose  clinical chemistry  glucometer  laboratory animal  method comparison  preclinical safety assessment
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