Evaluation of accuracy of FAD-GDH- and mutant Q-GDH-based blood glucose monitors in multi-patient populations

Background: Glucose dehydrogenases have been highly promoted to high-accuracy blood glucose (BG) monitors. The flavin adenine dinucleotide glucose dehydrogenase (FAD-GDH) and mutant variant of quinoprotein glucose dehydrogenase (Mut. Q-GDH) are widely used in high-performance BG monitors for multi-patient use. Therefore we conducted accuracy evaluation of the GDH monitors, FAD-GDH-based GM700 and Mut. Q-GDH-based Performa. Methods: Different patients were enrolled: patients with and without diabetes, patients receiving respiratory therapies, hemodialysis (HD) and peritoneal dialysis (PD) patients, and neonates. The accuracy evaluation of FAD-GDH- and Mut. Q-GDH-based monitors referred to ISO 15197:2013 which applies new criteria for the minion accuracy requirements: more than 95% of the blood glucose readings shall fall within +/- 15 mg/dL of the reference method at glucose concentration <100 mg/dL and within +/- 15% of the reference method at glucose concentration >= 100 mg/dL. Bland-Altman plots were used to evaluate the 2 GDH monitors as well. Results: Bland-Altman plots visualized excellent precision of the BG monitors. The 95% limit agreement of overall results for the FAD-GDH-based monitors was within +/- 12% and that for the Mut. Q-GDH-based monitors was from -10 to +17%. Both BG monitors met the accuracy requirements of ISO 15197:2013. The FAD-GDH-based monitor performed better with neonates and patients with and without diabetes, and the Mut Q-GDH-based monitor performed better with HD and PD patients. Conclusions: Analytical results prove that the GDH-based monitors tolerate a broad BG concentration range, are oxygen independent, have BG specificity, and have minimal interference from hematocrit The GDH-based monitors are reliable for multi-patient use. (C) 2014 Elsevier B.V. All rights reserved.