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Multicentre evaluation of the Premier Hb9210 HbA1c analyser

  • W. Garry John , Randie Little , David B. Sacks , Cas Weykamp , Erna Lenters-Westra , Theresa Hornsby , Zhen Zhao , Carla Siebelder , Alethea Tennill and Emma English EMAIL logo
Published/Copyright: October 2, 2014
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 53 Issue 2

Abstract

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.

Keywords: affinity chromatography; diabetes; glycated haemoglobin; HbA1c; multicentre evaluation
Corresponding author: Dr. Emma English, School of Medicine, University of Nottingham, Royal Derby Hospital, Nottingham DE22 3DT, UK, Phone: +44 1332 724620, E-mail:

Acknowledgments

The authors would like to thank Trinity Biotech for the contribution of the instruments and reagents for this evaluation. The authors would like to thank Jeffrey Basilio at the National Institutes for Health and Liesbeth Schröer-Janssen for their contribution running and analysis of the evaluation.

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Financial support: This work was funded in part by the Intramural Research Program of the National Institutes of Health (to D.B.S. and Z.Z.).

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Received: 2014-6-2
Accepted: 2014-9-4
Published Online: 2014-10-2
Published in Print: 2015-2-1

©2015 by De Gruyter

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https://doi.org/10.1515/cclm-2014-0589
Keywords for this article
affinity chromatography; diabetes; glycated haemoglobin; HbA1c; multicentre evaluation

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. The new and the old of heparin-induced thrombocytopenia
  4. Biological variation – reliable data is essential
  5. Biological variation: back to basics
  6. Review
  7. Influence of educational, audit and feedback, system based, and incentive and penalty interventions to reduce laboratory test utilization: a systematic review
  8. Opinion Papers
  9. Recent guidelines and recommendations for laboratory assessment of the direct oral anticoagulants (DOACs): is there consensus?
  10. Meeting report: present state of molecular genetics in clinical laboratories. Report on the VII European Symposium on Clinical Laboratory and In Vitro Diagnostic Industry in Barcelona
  11. Genetics and Molecular Diagnostics
  12. Non-invasive prenatal diagnosis of monogenic disorders: an optimized protocol using MEMO qPCR with miniSTR as internal control
  13. A novel biosensor-based microarray assay for the visualized detection of CYP2C19 ∗2, ∗3, ∗4 and ∗5 polymorphisms
  14. General Clinical Chemistry and Laboratory Medicine
  15. Preanalytical errors: a preliminary approach to the point of view of primary health care givers
  16. Comparison of Improvacuter™ tubes with BD Vacutainer™ tubes for various hormones in the aspects of stability and influence of gel separators
  17. Use of quality indicators to compare point-of-care testing errors in a neonatal unit and errors in a STAT central laboratory
  18. Serological features of antibodies to protamine inducing thrombocytopenia and thrombosis
  19. Comparison of three different immunoassays in the diagnosis of heparin-induced thrombocytopenia
  20. How the direct oral anticoagulant apixaban affects hemostatic parameters. Results of a multicenter multiplatform study
  21. Auto-validation of complete blood counts in an outpatient’s regional laboratory
  22. Performance evaluation of the digital cell imaging analyzer DI-60 integrated into the fully automated Sysmex XN hematology analyzer system
  23. Circulating keratan sulfate as a marker of metabolic changes of cartilage proteoglycan in juvenile idiopathic arthritis; influence of growth factors as well as proteolytic and prooxidative agents on aggrecan alterations
  24. Reference Values and Biological Variations
  25. Biological variation database: structure and criteria used for generation and update
  26. Cardiovascular Diseases
  27. The tumor necrosis factor-α –238G/A and IL-6 –572G/C gene polymorphisms and the risk of idiopathic dilated cardiomyopathy: a meta-analysis of 25 studies including 9493 cases and 13,971 controls
  28. Diabetes
  29. Multicentre evaluation of the Premier Hb9210 HbA1c analyser
  30. Infectious Diseases
  31. Determination of quality control limits for serological infectious disease testing using historical data
  32. Corrigendum
  33. Enrichment and enumeration of circulating tumor cells by efficient depletion of leukocyte fractions
  34. Letters to the Editors
  35. Influence of age and gender on red blood cell distribution width
  36. Effect of exhaustive running exercise on red blood cell distribution width
  37. Clinically useful samples and reference change value
  38. Loss of retinol stability in patient samples
  39. Evaluation of a new thyroglobulin sensitive assay in patients with differentiated thyroid cancer
  40. Caution in a case of highly discrepant carbohydrate antigen 19-9 values in an apparently healthy patient taking spirulina: a case report
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  42. Evaluation of the diagnostic characteristics of urinary kidney injury molecule 1 (uKIM-1) and uKIM-1/creatinine ratio in the assessment of incipient diabetic kidney disease
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