HbA1c-testing: Evaluation of two point-of-care analysers
Open accessAbstract
Background HbA 1c is a critical parameter for the medical management of patients with diabetes mellitus. Interventions that reduce HbA 1c levels lead to a diminution of microvascular complications. For two decades, point of care testing (POCT) methods have been regularly used to measure HbA 1c. The results significantly impact on the management of patients with diabetes mellitus and the accuracy of the results is critical. It is important to know the performance of common methods of HbA 1c measurements in daily life. We, therefore, aimed at evaluating the accuracy of two different analysers especially developed for POCT and compared them to a reference method. Methods We prospectively tested two widely used POCT methods to measure HbA 1c, namely Afinion™ AS100 Analyzer (Axis-Shield, Oslo Norway) and DCA Vantage™ Analyzer (Siemens Healthcare Diagnostics, Tarrytown NY, US) in venous samples of 100 patients. As a reference method, we used the high-performance liquid chromatography method G8 HPLC used in the Biochemistry Laboratory of the Inselspital Bern. The National Glycohaemoglobin Standardization Program (NGSP) has certificated all methods used in this study. The comparability and degree of agreement was assessed using Bland-Altman plot. Results The HbA 1c levels ranged from 33 to 116 mmol/mol (5.2-12.8%), 31-122 mmol/mol (5.0-13.3%) and 30-119 mmol/mol (4.9-13%) for Afinion™, DCA Vantage™ and G8 HPLC Analyzer, respectively. The 95% limits of agreement were between -0.84 and +0.30 for the Afinion™ and -0.71 and +0.29 for DCA Vantage™. The results of both POCT were significantly lower with a bias of -0.27% and -0.21% (p < 0.0001) for Afinion™ and DCA Vantage™ Analyzer, respectively. Conclusions The POCT methods tested in this study showed a good correlation with the laboratory reference method, however, with an overall negative bias.
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The systematic review and meta-analysis included 11 studies involving 1,593 participants and 3,285 paired HbA1c measurements comparing POC devices with reference HPLC-based laboratory methods.
“A total of 11 studies involving 1,593 participants and 3,285 paired measurements were included.”
From Comparison of point‑of‑care HbA1c devices with laboratory HPLC methods: A systematic review and meta‑analysis (2026) · cites this paper as [29]
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- Authors
- Dubach, I. L., Christ, E. R., & Diem, P.
- Affiliations
- University of Bern (CH)
- University of Basel (CH)
- Corresponding author
- Diem, Peter
- Venue
- Primary Care Diabetes
- Publisher
- Elsevier BV
- Published
- 2019-12
- Volume
- 13
- Issue
- 6
- Pages
- 583-587
- ISSN
- 1751-9918 (ISSN-L)
- OpenAlex
- W2948995452
- Cited by
- 9
- References
- 21
- Citations by year
- 2026: 2 · 2025: 1 · 2024: 1 · 2023: 1 · 2022: 1 · 2021: 1 · 2020: 1 · 2019: 1
- FWCI
- 0.69
- Type
- journal article
- Language
- en
- Open access
- green
- doi.org
- Locations
- Primary care diabetes (publishedVersion)
- PubMed (publishedVersion)
- Zurich Open Repository and Archive (University of Zurich) (acceptedVersion)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion)
- Zurich Open Repository and Archive (University of Zurich)
- Funders
- University Clinic for Endocrinology, Diabetes and Clinical Nutrition of Inselspital Bern, Switzerland
- Topics
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Clinical Biochemistry › Advanced Glycation End Products research
- Keywords
- HbA1c, point-of-care testing, measurement accuracy, diabetes mellitus, venous blood samples, method comparison
- MeSH terms
- Point-of-Care Testing, Diabetes Mellitus, Equipment Design, Glycated Hemoglobin, Humans, Prospective Studies, Reference Standards, Reproducibility of Results, Point-of-Care Systems
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