Verification of a novel point-of-care HbA1c device in real world clinical practice by comparison to three high performance liquid chromatography instruments
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Introduction: A real world clinical study was designed and conducted to evaluate the performance of a novel point-of-care device for determination of glycated haemoglobin A 1c (HbA 1c ), A1C EZ 2.0, in daily clinical practice.Materials and methods: Five hundred and fourteen subjects were included in this study, and divided into three groups.HbA 1c was measured by A1C EZ 2.0 and three different high performance liquid chromatography (HPLC) devices: Bio-Rad Variant II Turbo, Tosoh HLC-723 G8 and Premier Hb9210 separately.Precision of A1C EZ 2.0 was also evaluated.Results: Results obtained from A1C EZ 2.0 and all HPLC devices are correlated.Passing-Bablok regression analysis shows the equation of A1C EZ 2.0 results against the mean of HPLC devices with corresponding 95% confidence intervals (95% CI) for the intercept and slope is y = 0.10 (-0.17 to 0.10) + 1.00 (1.00 to 1.04) x.Bland-Altman difference plot shows that the mean relative difference between A1C EZ 2.0 and Variant II Turbo, G8, Hb9210 and all HPLC results is 2.5%, 0.6%, 0.4% and 1.1%, respectively.In addition, 121 pairs of results determined by using both venous and capillary blood prove that the difference of two kinds of blood sample causes no notable variation when measured by A1C EZ 2.0.Precision study gives 2.3% and 1.9% of total coefficient of variation for normal and abnormal HbA 1c sample in A1C EZ 2.0.Conclusions: HbA 1c values measured by A1C EZ 2.0 were in good accordance with the results obtained with the reference HPLC devices.
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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 [27]
The Materials and methods (Study design) describe a single analytical verification study, not a systematic review or meta-analysis. Statistical analysis reports 514 subjects and 635 pairs of data, contrary to the attributed totals of 11 studies, 1,593 participants and 3,285 paired measurements. Page numbers are unavailable in our copy. (LLM, conf=0.90)
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Wei, Y., Gu, M., Ren, Y., & Hu, Z. (2026) · Biomedical Reports · doi:10.3892/br.2026.2120 · Cited by 3 · see citing works
- Authors
- Wang, Y., Peng, W., Tang, J., Dong, L., Gu, C., Zhang, X., Zhou, J., & Jia, W.
- Affiliations
- Shanghai Jiao Tong University (CN)
- Wuxi Municipal Bureau on Science and Technology (CN)
- Corresponding author
- Zhou, Jian
- Venue
- Biochemia Medica
- Published
- 2018-04-15
- Volume
- 28
- Issue
- 2
- Pages
- 020705-020705
- ISSN
- 1330-0962 (ISSN-L)
- 1846-7482
- PMC
- PMC5898960
- OpenAlex
- W2797485890
- Cited by
- 11
- References
- 4
- Citations by year
- 2026: 2 · 2024: 2 · 2023: 3 · 2022: 1 · 2021: 1 · 2019: 2
- FWCI
- 0.52
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Licence
- cc-by
- Locations
- Biochemia Medica (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- 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, HPLC, method comparison, diabetes monitoring, capillary blood, venous blood, measurement precision, real-world clinical practice
- MeSH terms
- Adolescent, Adult, Aged, Aged, 80 and over, Analysis of Variance, Chromatography, High Pressure Liquid, Diabetes Mellitus, Female, Glycated Hemoglobin, Humans, Male, Middle Aged, Sensitivity and Specificity, Reproducibility of Results, Case-Control Studies, Point-of-Care Systems, Automation, Laboratory
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