Multicentre evaluation of the Premier Hb9210 HbA1c analyser

John, Garry, Little, Randie, Sacks, David B., Lenters-Westra, Erna, Hornsby, Theresa, Zhao, Zhen, Siebelder, Carla, Tennill, Alethea and English, Emma ORCID: (2014) Multicentre evaluation of the Premier Hb9210 HbA1c analyser. Clinical Chemistry and Laboratory Medicine, 53 (2). pp. 319-327. ISSN 1434-6621

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Background: The accurate and precise quantification of HbA1c is essential for the diagnosis and routine monitoring of patients with diabetes. We report an evaluation of the Trinity Biotech Premier Hb9210 analyser (Bray, Ireland/Kansas City, MO, USA), a boronate affinity chromatography-based high performance liquid chromatography (HPLC) system for the measurement of glycated haemoglobin. Methods: We evaluated the analytical performance of the Hb9210 as part of a multicentre evaluation. The effect of haemoglobin variants, other potential interferences and the performance in comparison to both the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and National Glycohemoglobin Standardization Program (NGSP) reference systems, was assessed. Most of the centres participating also act as reference laboratories for both the IFCC standardisation network for HbA1c and the NGSP. Results: The combined data from all centres showed total coefficients of variation (CV) of 2.71%, 2.32% and 2.14% at low, medium and high values, respectively, for mmol/mol (SI units) and 1.62%, 1.59% and 1.68% for % (NGSP units), which are well below the recommended upper limits of 3% CV for mmol/mol (SI units) and 2% CV for % (NGSP). The analyser showed a good correlation to HbA1c methods currently used in clinical practice and the IFCC reference method procedure. Haemoglobin variants AC, AS, AE and AD do not affect the measurement of HbA1c. Overall the Hb9210 performs well across the whole analytical range. Conclusions: The Hb9210 performs well and is suitable for clinical application in the analysis of HbA1c.

Item Type: Article
Uncontrolled Keywords: affinity chromatography,diabetes,glycated haemoglobin,hba1c,multicentre evaluation,sdg 3 - good health and well-being ,/dk/atira/pure/sustainabledevelopmentgoals/good_health_and_well_being
Faculty \ School: Faculty of Medicine and Health Sciences > School of Health Sciences
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Groups > Health Promotion
Depositing User: Pure Connector
Date Deposited: 19 Jan 2016 11:00
Last Modified: 22 Oct 2022 00:41
DOI: 10.1515/cclm-2014-0589

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