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HbA1c-testing: Evaluation of two point-of-care analysers
Irina L Dubach1, Emanuel R Christ2, Peter Diem3
1Division of Internal Medicine, University of Zurich, Zurich, Switzerland; Diabetes Technology Research Group, ARTORG Center for Biomedical Engineering Research, University of Bern, Bern, Switzerland.
Insights
Point of care testing (POCT) for HbA1c offers convenience, but accuracy is key for diabetes management. This study found that while POCT methods correlate well with lab results, they show a slight negative bias.
Area of Science:
- Clinical Chemistry
- Point-of-Care Testing
- Diabetes Mellitus Management
Background:
- Hemoglobin A1c (HbA1c) is crucial for managing diabetes mellitus.
- Reducing HbA1c levels minimizes microvascular complications.
- Point of Care Testing (POCT) for HbA1c has been standard for two decades, impacting patient management.
Purpose of the Study:
- To evaluate the accuracy of two common POCT HbA1c analyzers.
- To compare POCT results against a high-performance liquid chromatography (HPLC) reference method.
Main Methods:
- Prospective testing of Afinion™ AS100 and DCA Vantage™ analyzers with 100 patient samples.
- Comparison with the G8 HPLC reference method.
- Assessment of comparability and agreement using Bland-Altman plots.
Main Results:
- HbA1c levels varied across methods, with POCT analyzers showing a slight negative bias.
- Afinion™ showed a bias of -0.27% (95% limits of agreement: -0.84 to +0.30).
- DCA Vantage™ showed a bias of -0.21% (95% limits of agreement: -0.71 to +0.29).
Conclusions:
- Both POCT methods demonstrated good correlation with the laboratory reference method.
- A consistent negative bias was observed across the tested POCT analyzers.
- While POCT is valuable, awareness of this bias is important for accurate diabetes care.
Background:
HbA1c is a critical parameter for the medical management of patients with diabetes mellitus. Interventions that reduce HbA1c levels lead to a diminution of microvascular complications. For two decades, point of care testing (POCT) methods have been regularly used to measure HbA1c. 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 HbA1c 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 HbA1c, 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 HbA1c 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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