Jump to ContentJump to Main Navigation
Show Summary Details
More options …

Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter / Tate, Jillian R.

12 Issues per year


IMPACT FACTOR 2016: 3.432

CiteScore 2016: 2.21

SCImago Journal Rank (SJR) 2016: 1.000
Source Normalized Impact per Paper (SNIP) 2016: 1.112

Online
ISSN
1437-4331
See all formats and pricing
More options …
Volume 55, Issue 9 (Aug 2017)

Issues

Evaluating new HbA1c methods for adoption by the IFCC and NGSP reference networks using international quality targets

Erna Lenters-Westra
  • Corresponding author
  • Department of Clinical Chemistry, Isala, Dr. van Heesweg 2, 8025 AB Zwolle, The Netherlands
  • European Reference Laboratory for Glycohemoglobin, Isala, Zwolle, The Netherlands
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Emma English
  • Faculty of Medicine and Health, University of East Anglia, Norwich Research Park, Norwich, England, UK
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2017-04-22 | DOI: https://doi.org/10.1515/cclm-2017-0109

Abstract

Background:

As a reference laboratory for HbA1c, it is essential to have accurate and precise HbA1c methods covering a range of measurement principles. We report an evaluation of the Abbott Enzymatic (Architect c4000), Roche Gen.3 HbA1c (Cobas c513) and Tosoh G11 using different quality targets.

Methods:

The effect of hemoglobin variants, other potential interferences and the performance in comparison to both the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the National Glycohemoglobin Standardization Program (NGSP) reference systems was assessed using certified evaluation protocols.

Results:

Each of the evaluated HbA1c methods had CVs <3% in SI units and <2% in NGSP units at 46 mmol/mol (6.4%) and 72 mmol/mol (8.7%) and passed the NGSP criteria when compared with six secondary reference measurement procedures (SRMPs). Sigma was 8.6 for Abbott Enzymatic, 3.3 for Roche Cobas c513 and 6.9 for Tosoh G11. No clinically significant interference was detected for the common Hb variants for the three methods.

Conclusions:

All three methods performed well and are suitable for clinical application in the analysis of HbA1c. Partly based on the result of this study, the Abbott Enzymatic method on the Architect c4000 and the Roche Gen.3 HbA1c on the Cobas c513 are now official, certified IFCC and NGSP SRMPs in the IFCC and NGSP networks. Sigma metrics quality criteria presented in a graph distinguish between good and excellent performance.

This article offers supplementary material which is provided at the end of the article.

Keywords: diabetes; HbA1c; IFCC; method evaluation; sigma metrics

References

  • 1.

    Federation ID. IDF diabetes Atlas, 7th ed. Brussels: Belgium International Diabetes Federation, 2015.Google Scholar

  • 2.

    WHO guidelines Use of glycated hemoglobin A1c in the daignosis of diabetes. Available at: www.who.int/diabetes/publications/diagnosis_diabetes2011/en/. Accessed: January 2017.

  • 3.

    Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2015;38:140–9.Web of ScienceCrossrefGoogle Scholar

  • 4.

    Weykamp C, John G, Gillery P, English E, Ji L, Lenters-Westra E, et al. Investigation of 2 models to set and evaluate quality targets for HbA1c: biological variation and sigma-metrics. Clin Chem 2015;61:752–9.Web of ScienceCrossrefGoogle Scholar

  • 5.

    Approved laboratories of the IFCC network laboratories for HbA1c 2016. Available at: www.ifcchba1c.net/network/approved. Accessed: January 2017.

  • 6.

    NGSP Network Laboratory Members 2016. Available at: www.ngsp.org/network.asp. Accessed: January 2017.

  • 7.

    Jaisson S, Desmons A, Renard B, Chevelle B, Leroy N, Gillery P. Analytical performances of a new enzymatic assay for hemoglobin A1c. Clin Chim Acta 2014;434:48–52.Web of ScienceGoogle Scholar

  • 8.

    Teodoro-Morrison T, Janssen MJ, Mols J, Hendrickx BH, Velmans MH, Lotz J, et al. Evaluation of a next generation direct whole blood enzymatic assay for hemoglobin A1c on the ARCHITECT c8000 chemistry system. Clin Chem Lab Med 2015;53:125–32.Web of ScienceGoogle Scholar

  • 9.

    Imdahl R, Röddiger R, Casis-Saenz E. Multicenter evaluation of a new high-throughput HbA1c testing platform. Clin Lab 2016;62:2405–12.CrossrefWeb of ScienceGoogle Scholar

  • 10.

    Institute CaLS. Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline. NCCLS Document EP05-A. PA: CLSI Wayne, 1992.Google Scholar

  • 11.

    Institute CaLS. Method Comparison and Bias Estimation using Patient Samples; Approved Guideline. CLSI Document EP09-A PA: CLSI Wayne, 1995.Google Scholar

  • 12.

    Institute CaLS. Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. CLSI Document EP06-A (2003). PA: CLSI Wayne, 2003.Google Scholar

  • 13.

    Weykamp CW, Penders TJ, Siebelder CW, Muskiet FA, van der Slik W. Interference of carbamylated and acetylated hemoglobins in assays of glycohemoglobin by HPLC, electrophoresis, affinity chromatography, and enzyme immunoassay. Clin Chem 1993;39:138–42.Google Scholar

  • 14.

    NGSP Manufacturer Certification Criteria. Available at: www.ngsp.org/critsumm.asp. Accessed: January 2017.

  • 15.

    EP Evaluator Data Innovations. Available at: www.datainnovations.com/products/ep-evaluator. Accessed: January 2017.

  • 16.

    NGSP Protocol Laboratory Network. Available at: www.ngsp.org/protln.asp. Accessed: January 2017.

  • 17.

    Lenters-Westra E, English E. Understanding the use of sigma metrics in hemoglobin A1c analysis. Clin Lab Med 2017;37:57–71.Web of ScienceGoogle Scholar

  • 18.

    College of American Pathology External Quality Scheme for HbA1c 2016. Available at: www.ngsp.org/CAP/CAP16c.pdf. Accessed: January 2017.

  • 19.

    Rohlfing C, Hanson S, Weykamp CW, Siebelder C, Higgens T, Molinaro R, et al. Effect of hemoglobin C,D,E and S traits on measurements of hemoglobin A1c by twelve methods. Clin Chim Acta 2016;455:80–3.Google Scholar

  • 20.

    Lenters-Westra E. Common Hb-variants show no longer interference on the Tosoh G8 after an update of the software. Clin Chim Acta 2016;463:73–4.Web of ScienceGoogle Scholar

About the article

Received: 2017-02-06

Accepted: 2017-03-28

Published Online: 2017-04-22

Published in Print: 2017-08-28


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

Research funding: Tosoh Bioscience financially supported the study.

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.


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2017-0109.

Export Citation

©2017 Walter de Gruyter GmbH, Berlin/Boston. Copyright Clearance Center

Supplementary Article Materials

Citing Articles

Here you can find all Crossref-listed publications in which this article is cited. If you would like to receive automatic email messages as soon as this article is cited in other publications, simply activate the “Citation Alert” on the top of this page.

[1]
Sten A. Westgard, Hassan Bayat, and James O. Westgard
Journal of Diabetes Science and Technology, 2017, Page 193229681772948

Comments (0)

Please log in or register to comment.
Log in