Ta-Yu Huang1, Hui-Wen Chang2, Mei-Fen Tsao2, Shu-Ming Chuang1, Chih-Chin Ni1, Jun-Wei Sue1, Hsiu-Chen Lin3, Cheng-Teng Hsu4. 1. R&D Department, Bionime Corporation, Taichung, Taiwan. 2. Department of Laboratory Medicine, Taipei Medical University Hospital, Taipei, Taiwan. 3. Department of Laboratory Medicine, Taipei Medical University Hospital, Taipei, Taiwan; Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. Electronic address: ma0105ry@yahoo.com.tw. 4. School of Medical Laboratory and Biotechnology, Chung Shan Medical University, Taichung, Taiwan. Electronic address: a629405@ms27.hinet.net.
Abstract
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 ±15mg/dL of the reference method at glucose concentration <100mg/dL and within ±15% of the reference method at glucose concentration ≥100mg/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.
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 ±15mg/dL of the reference method at glucose concentration <100mg/dL and within ±15% of the reference method at glucose concentration ≥100mg/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 PDpatients. 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.