Comparison of a point-of-care analyser for the determination of HbA1c with HPLC method
Open accessAbstract
AIMS: As the use of Point of Care Testing (POCT) devices for measurement of glycated haemoglobin (HbA1c) increases, it is imperative to determine how their performance compares to laboratory methods. This study compared the performance of the automated Quo-Test POCT device (EKF Diagnostics), which uses boronate fluorescence quenching technology, with a laboratory based High Performance Liquid Chromatography (HPLC) method (Biorad D10) for measurement of HbA1c. METHODS: Whole blood EDTA samples from subjects (n=100) with and without diabetes were assayed using a BioRad D10 and a Quo-Test analyser. Intra-assay variation was determined by measuring six HbA1c samples in triplicate and inter-assay variation was determined by assaying four samples on 4 days. Stability was determined by assaying three samples stored at -20 °C for 14 and 28 days post collection. RESULTS: =0.969, P<0.0001). Mean (range) intra- and inter-assay variation was 1.2% (0.0-2.7%) and 1.6% (0.0-2.7%) for the D10 and 3.5% (0.0-6.7%) and 2.7% (0.7-5.1%) for the Quo-Test. Mean change in HbA1c after 28 days storage at -20 °C was -0.7% and +0.3% for D10 and Quo-Test respectively. Compared to the D10, Quo-Test showed 98% agreement for diagnosis of glucose intolerance (IGT and T2DM) and 100% for diagnosis of T2DM. CONCLUSION: Good agreement between the D10 and Quo-Test was seen across a wide HbA1c range. The Quo-Test POCT device provided similar performance to a laboratory based HPLC method.
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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 [12]
The Abstract (Methods) and Materials and methods (Method comparison; page unavailable) describe a single comparison using 100 blood samples, not a systematic review or meta-analysis of 11 studies. The cited paper therefore does not support the attributed totals of 1,593 participants and 3,285 paired measurements. (LLM, conf=0.90)
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Research works printed but not linked: 8
- [1]Alberti K.G. Zimmet P.Z. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation Diabet. Med. 15 1998 539 553 9686693
- [2]Ejilemele A. Unabia J. Ju H. Petersen J.R. A1c Gear: laboratory quality HbA1c measurement at the point of care Clin. Chem. Acta 445 2015 139 142 25801216
- [3]Mishra A. Garg S. HbA1c and blood glucose for the diagnosis of diabetes Lancet 378 2011 104 106 21705066
- [4]Use of Glycated Haemoglobin (HbA1c) in the Diagnosis of Diabetes Mellitus, Abbreviated report of a WHO Consultation, World Health Organisation, 2011. 26158184
- [5]International Expert Committee International expert committee report on the role of A1C assay in the diagnosis of diabetes Diabetes Care 32 2009 1327 19502545 PMC2699715
- [6]Sacks D.B. Arnold M. Bakris G.L. Bruns D.E. Horvath A.R. Kirkman M.S. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus Clin. Chem. 57 2011 e1 47 21617152
- [7]Saudek C.D. Brick J.C. The clinical use of hemoglobin A1c J. Diab. Sci. Technol. 3 2009 629 634 PMC2769940 20144304
- [8]John W.G. Use of HbA1c in the diagnosis of diabetes mellitus in the UK. The implementation of the World Health Organization guidance 2011 Diabet. Med. 29 2012 1350 1357 22957983
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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
“While several studies have assessed individual device performance, results remain incon‑ sistent (11,12).”
- Authors
- Grant, D. A., Dunseath, G. J., Churm, R., & Luzio, S. D.
- Affiliations
- Swansea University (GB)
- Corresponding author
- Dunseath, G.J.
- Venue
- Practical Laboratory Medicine
- Publisher
- Elsevier BV
- Published
- 2017-08
- Volume
- 8
- Pages
- 26-29
- ISSN
- 2352-5517 (ISSN-L)
- PMC
- PMC5575368
- OpenAlex
- W2604375643
- Cited by
- 14
- References
- 0
- Citations by year
- 2026: 2 · 2025: 1 · 2024: 1 · 2023: 2 · 2022: 1 · 2021: 2 · 2020: 2 · 2019: 1 · 2017: 2
- FWCI
- 1.01
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Practical Laboratory Medicine (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- 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 comparison, assay precision, sample stability, diabetes diagnosis, impaired glucose tolerance, type 2 diabetes
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