The DOI matches its Crossref record; 11 of the 11 references it cites were found in a registry or an index.
Hemoglobin A1c Point-of-Care Assays; A New World with a Lot of Consequences!
Open accessAbstract
Background Point-of-care instruments for the measurement of hemoglobin A1c (HbA1c) may improve the glycemic control of people with diabetes by providing a rapid result if the performance of the instruments used is acceptable. A 0.5% HbA1c difference between successive results is considered a clinically relevant change. With this in mind, the In2it from Bio-Rad and the DCA Vantage from Siemens were evaluated according to Clinical and Laboratory Standards Institute (CLSI) protocols. Methods The CLSI protocols EP-5 and EP-9 were applied to investigate precision, accuracy, and bias. The bias was compared with three certified secondary reference measurement procedures. Differences between capillary and venous blood were investigated by an end-user group consisting of nurse practitioners at a diabetes care center. Results At HbA1c levels of 5.1 and 11.2%, total coefficients of variation (CV) for the In2it were 4.9 and 3.3%, respectively, and for the DCA Vantage were 1.7 to 1.8% and 3.7 to 5.5% depending on the lot number of the cartridges. Method comparisons showed significant lot number-dependent results for the In2it and the DCA Vantage compared with the three reference methods. No overall difference was observed between capillary and venous blood for both methods. Conclusion Performance results of the In2it and the DCA Vantage showed variable and lot number-dependent results. To maintain the interlaboratory CV of 5% for HbA1c, the Clinical Laboratory Improvement Amendments rules…
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The pooled mean difference of 0.01% is well within the clinically acceptable margin of ±0.5%.
“well within the clinically acceptable margin of ±0.5%.”
From Comparison of point‑of‑care HbA1c devices with laboratory HPLC methods: A systematic review and meta‑analysis (2026) · cites this paper as [35]
The clinically acceptable margin for HbA1c measurement is ±0.5%.
“spanning the clinically acceptable margin of ±0.5% (35).”
From Comparison of point‑of‑care HbA1c devices with laboratory HPLC methods: A systematic review and meta‑analysis (2026) · cites this paper as [35]
Previous reviews have emphasized that variability remains a persistent challenge in standardizing HbA1c measurement across platforms and settings.
“Previous reviews have emphasized that such variability remains a persistent challenge in standardizing HbA1c measurement across platforms and settings (10,35).”
From Comparison of point‑of‑care HbA1c devices with laboratory HPLC methods: A systematic review and meta‑analysis (2026) · cites this paper as [35]
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Metadata
- Authors
- Lenters-Westra, E., & Slingerland, R. J.
- Affiliations
- Department of Clinical Chemistry, Isala klinieken, Zwolle, The Netherlands
- Isala (NL)
- Venue
- Journal of Diabetes Science and Technology
- Publisher
- SAGE Publications
- Published
- 2009-05
- Volume
- 3
- Issue
- 3
- Pages
- 418-423
- ISSN
- 1932-2968 (ISSN-L)
- PMC
- PMC2769862
- OpenAlex
- W2000610385
- Cited by
- 31
- References
- 11
- Citations by year
- 2026: 2 · 2024: 1 · 2022: 3 · 2021: 1 · 2020: 3 · 2019: 2 · 2018: 2 · 2017: 1 · 2016: 4 · 2015: 1 · 2014: 3 · 2013: 3
- Type
- conference abstract
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Diabetes Science and Technology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Health Professions › Medical Laboratory Technology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Physical Sciences › Physics and Astronomy › Instrumentation › Scientific Measurement and Uncertainty Evaluation
- Keywords
- HbA1c, point-of-care testing, precision and accuracy, external quality assessment, Clinical Laboratory Improvement Amendments, nurse practitioners
- MeSH terms
- Blood Glucose, Capillaries, Clinical Protocols, Glycated Hemoglobin, Humans, Quality Control, Veins, Reproducibility of Results, Point-of-Care Systems
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