Evaluation of a HbA1c point-of-care analyzer
Abstract
Objectives A better glycemic monitoring of diabetic patients and avoiding complications of poorly controlled diabetes could be possible with point-of-care testing technology (POCT) for HbA1c determination. B-Analyst® was studied to check whether it complied with the quality requirements for this purpose. Design and methods We evaluated the B-Analyst® (Menarini Diagnostics), which is based in the principle of latex agglutination immunoturbidimetry, to assess the validity of the technique of HbA1c. We carried out the method comparison with the HA-8180® (Menarini Diagnostics) as a reference method [High Performance Liquid Chromatography (HPLC)]. We assessed the analytical quality of the B-Analyst® studying the accuracy: inter-assay variability and intra-assay study. Furthermore, possible interferences by hemoglobinopathies were studied. Results Regression analysis of the data for the method comparison between HA-8180® and B-Analyst® showed a slope of 1.0085 and an intercept of 0.1208. The Pearson's correlation coefficient was 0.9958 (p<0.0001). Bias study showed a mean difference from B-Analyst® with respect to HA-8180® of 0.1872 with a 95% confidence interval. The standard error of the estimate (Syx) was 0.2091. The concordance correlation coefficient to assess accuracy was 0.9922 (0.9891-0.9945). The CV for the inter-assay study was 1.4%. For the intra-assay study we analyzed 3 samples with different HbA1c % whose CV were 1.03% [4.7% HbA1c (28 mmol/mol)], 0.46% [6.4% HbA1c (46 mmol/mol)] and 0.78% [8.1% HbA1c (65 mmol/mol)]. Conclusion The B-Analyst® evaluated not only showed good correlation with HA-8180®, but also it presented a great accuracy both in the inter-assay and in the intra-assay studies. The B-Analyst® complies with quality specifications required for monitoring of diabetic patients.
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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 [26]
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- Authors
- Menéndez-Valladares, P., Fernández-Riejos, P., Sánchez-Mora, C., Pérez-Pérez, A., Sánchez-Margalet, V., & González-Rodríguez, C.
- Affiliations
- Hospital Universitario Virgen Macarena (ES)
- Corresponding author
- Menéndez-Valladares, Paloma
- Venue
- Clinical Biochemistry
- Publisher
- Elsevier BV
- Published
- 2015-07
- Volume
- 48
- Issue
- 10-11
- Pages
- 686-689
- ISSN
- 0009-9120 (ISSN-L)
- OpenAlex
- W1985278698
- Cited by
- 8
- References
- 23
- Citations by year
- 2023: 2 · 2022: 1 · 2017: 1 · 2016: 4
- FWCI
- 1.23
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinical Biochemistry (publishedVersion)
- 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, method comparison, analytical accuracy, inter-assay variability, hemoglobinopathies, assay interference
- MeSH terms
- Chromatography, High Pressure Liquid, Diabetes Mellitus, Glycated Hemoglobin, Humans, Point-of-Care Systems
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