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Cited by 15Clinical Laboratory Practices and Quality ControlDiabetes Management and ResearchElectrochemical sensors and biosensors

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

Huang, Ta-Yu, Chang, Hui-Wen, Tsao, Mei-Fen, Chuang, Shu-Ming, Ni, Chih-Chin, Sue, Jun-Wei, Lin, Hsiu-Chen, Hsu, Cheng-Teng·2014·Clinica Chimica Acta
DOI 10.1016/j.cca.2014.02.023
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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.

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Metadata

Authors
Huang, T.-Y., Chang, H.-W., Tsao, M.-F., Chuang, S.-M., Ni, C.-C., Sue, J.-W., Lin, H.-C., & Hsu, C.-T.
Affiliations
  • Taipei Medical University Hospital (TW)
  • Chung Shan Medical University (TW)
Corresponding author
  • Lin, Hsiu-Chen
  • Hsu, Cheng-Teng
ORCID
Venue
Clinica Chimica Acta
Publisher
Elsevier BV
Published
2014-06
Volume
433
Pages
28-33
ISSN
0009-8981 (ISSN-L)
DOI
10.1016/j.cca.2014.02.023
OpenAlex
W2025267443
Cited by
15
References
36
Citations by year
2025: 1 · 2024: 1 · 2022: 1 · 2021: 1 · 2018: 3 · 2017: 2 · 2016: 3 · 2015: 3
FWCI
1.78
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Clinica Chimica Acta (publishedVersion)
  • PubMed (publishedVersion)
  • Taipei Medical University Repository (submittedVersion)
Funders
U.S. Food and Drug Administration
Topics
  • Health Sciences › Health Professions › Medical Laboratory Technology › Clinical Laboratory Practices and Quality Control
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Physical Sciences › Chemistry › Analytical Chemistry › Electrochemical sensors and biosensors
Keywords
glucose dehydrogenase, quinoprotein glucose dehydrogenase, blood glucose meters, glucose meter accuracy, ISO 15197:2013, hemodialysis patients, peritoneal dialysis patients, neonates, diabetes mellitus, respiratory care, hematocrit interference
MeSH terms
Adult, Aged, Aged, 80 and over, Blood Chemical Analysis, Blood Glucose, Flavin-Adenine Dinucleotide, Female, Glucose Dehydrogenases, Humans, Infant, Newborn, Male, Middle Aged, Mutation, Young Adult

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Huang, T.-Y., Chang, H.-W., Tsao, M.-F., Chuang, S.-M., Ni, C.-C., Sue, J.-W., Lin, H.-C., & Hsu, C.-T. (2014). Evaluation of accuracy of FAD-GDH- and mutant Q-GDH-based blood glucose monitors in multi-patient populations. Clinica Chimica Acta. https://doi.org/10.1016/j.cca.2014.02.023