The interference by HbF on HbA1c (BM Test HbA1c) measurement in enzymatic method
Open accessAbstract
Background: High performance liquid chromatography and immunological and enzymatic methods are known as the methods for HbA1c measurement. However, the differences in the principles of the methods may cause slight discrepancies, which become problems especially in the regions where hemoglobinopathies that have high HbF concentrations are commonly seen. In this report, we discuss the effect of HbF on the HbA1c measurement by the enzymatic method (BM Test HbA1c) which can be applied to automatic analyzer of high sample throughput. Methods: Thirty-five samples (HbF concentration: between 1.4 and 90.1%) and 68 samples (HbF concentration: <1.0%) were analyzed by high performance liquid chromatography (Tosoh G8) and BM Test HbA1c. The results by BM Test HbA1c were compared with those by the high performance liquid chromatography and International Federation of Clinical Chemistry reference method. Results: The high and positive correlation coefficient was demonstrated between the enzymatic and International Federation of Clinical Chemistry methods for the samples with normal HbF concentration. The samples with high HbF concentration exhibited high and positive correlation coefficient, although the figure is lower than that of the normal HbF concentration group. Conclusions: BM Test HbA1c revealed a high and positive correlation with high performance liquid chromatography and International Federation of Clinical Chemistry reference methods. However, the HbA1c values by BM Test HbA1c and high performance liquid chromatography method were lower than those by International Federation of Clinical Chemistry reference method when the HbF concentration was high. BM Test HbA1c had some deviation from the International Federation of Clinical Chemistry reference method, while no significant interference was seen when the HbF values were less than 15%. When HbF is higher than 15%, however, the interpretation of HbA1c by BM Test may require some special consideration.
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Enzymatic methods are widely used in centralized laboratories and rely on endoglycosidase digestion followed by quantification of released glycated amino acids.
“In addition, although enzymatic methods are widely used in centralized laboratories and rely on endoglycosidase digestion followed by quantification of released glycated amino acids, no studies of enzymatic POC platforms met our inclusion criteria (42-44).”
From Comparison of point‑of‑care HbA1c devices with laboratory HPLC methods: A systematic review and meta‑analysis (2026) · cites this paper as [44]
The Conclusion (page unavailable) describes an enzymatic HbA1c method used with a high-throughput routine automated analyzer, but does not establish that enzymatic methods are widely used in centralized laboratories. The Discussion (page unavailable) describes endopeptidase cleavage that releases a glycated dipeptide, followed by its reaction with fructosyl peptide oxidase—not endoglycosidase digestion followed by quantification of released glycated amino acids. (LLM, conf=0.87)
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ปิยะสุวรรณยิ่ง, ล., & คงรัตนโชค, น. (2017) · doi:10.58837/chula.the.2017.1207
- Authors
- Nitta, T., Yamashiro, Y., Hattori, Y., Ezumi, T., Nishioka, M., & Nakamura, J.
- Affiliations
- Yamaguchi University (JP)
- Yamaguchi University Hospital (JP)
- Corresponding author
- Nitta, Takenori
- Venue
- Annals of Clinical Biochemistry: International Journal of Laboratory Medicine
- Publisher
- SAGE Publications
- Published
- 2015-01-13
- Volume
- 52
- Issue
- 5
- Pages
- 569-575
- ISSN
- 0004-5632 (ISSN-L)
- 1758-1001
- OpenAlex
- W2170706508
- Cited by
- 6
- References
- 8
- Citations by year
- 2025: 1 · 2024: 1 · 2021: 1 · 2017: 2 · 2015: 1
- FWCI
- 0.74
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Annals of Clinical Biochemistry International Journal of Laboratory Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Genetics › Hemoglobinopathies and Related Disorders
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Neonatal Health and Biochemistry
- Keywords
- HbA1c testing, fetal hemoglobin, enzyme activity assay, HPLC, hemoglobinopathies, HbA1c
- MeSH terms
- Chromatography, High Pressure Liquid, Fetal Hemoglobin, Glycated Hemoglobin, Humans, Reference Standards, Reproducibility of Results, Clinical Chemistry Tests, Enzyme Assays
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