title: Evaluation of accuracy of FAD-GDH- and mutant Q-GDH-based blood glucose monitors in multi-patient populations.
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.
authors.affiliation: R&D Department, Bionime Corporation, Taichung, Taiwan.
authors.forename: Ta-Yu
authors.initials: TY
authors.lastname: Huang
authors.affiliation: Department of Laboratory Medicine, Taipei Medical University Hospital, Taipei, Taiwan.
authors.forename: Hui-Wen
authors.initials: HW
authors.lastname: Chang
authors.affiliation: Department of Laboratory Medicine, Taipei Medical University Hospital, Taipei, Taiwan.
authors.forename: Mei-Fen
authors.initials: MF
authors.lastname: Tsao
authors.affiliation: R&D Department, Bionime Corporation, Taichung, Taiwan.
authors.forename: Shu-Ming
authors.initials: SM
authors.lastname: Chuang
authors.affiliation: R&D Department, Bionime Corporation, Taichung, Taiwan.
authors.forename: Chih-Chin
authors.initials: CC
authors.lastname: Ni
authors.affiliation: R&D Department, Bionime Corporation, Taichung, Taiwan.
authors.forename: Jun-Wei
authors.initials: JW
authors.lastname: Sue
authors.affiliation: 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.
authors.forename: Hsiu-Chen
authors.initials: HC
authors.lastname: Lin
authors.affiliation: School of Medical Laboratory and Biotechnology, Chung Shan Medical University, Taichung, Taiwan. Electronic address: a629405@ms27.hinet.net.
authors.forename: Cheng-Teng
authors.initials: CT
authors.lastname: Hsu
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001774:Blood Chemical Analysis / Q000379:methods* / Q000592:standards; D001786:Blood Glucose / Q000032:analysis*; D005260:Female; D005182:Flavin-Adenine Dinucleotide / Q000378:metabolism*; D005948:Glucose Dehydrogenases / Q000235:genetics* / Q000378:metabolism*; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D009154:Mutation; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D005182:Flavin-Adenine Dinucleotide; D005948:Glucose Dehydrogenases; C033955:glucose dehydrogenase (pyrroloquinoline-quinone)
keywords: Arterial blood; Blood glucose monitoring system; Glucose dehydrogenase; Hemodialysis; ISO 15197:2013; Neonate