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 / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2018: 3.638

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

Online
ISSN
1437-4331
See all formats and pricing
More options …
Volume 53, Issue 1

Issues

Evaluation of a next generation direct whole blood enzymatic assay for hemoglobin A1c on the ARCHITECT c8000 chemistry system

Tracy Teodoro-Morrison
  • Department of Laboratory Medicine and Pathobiology, University Health Network and University of Toronto, Toronto, Ontario, Canada
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Marcel J.W. Janssen
  • Viecuri Medical Center, Laboratory of Clinical Chemistry and Haematology, Venlo, The Netherlands
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Jasper Mols
  • Viecuri Medical Center, Laboratory of Clinical Chemistry and Haematology, Venlo, The Netherlands
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Ben H.E. Hendrickx
  • Viecuri Medical Center, Laboratory of Clinical Chemistry and Haematology, Venlo, The Netherlands
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Mathieu H. Velmans
  • Viecuri Medical Center, Laboratory of Clinical Chemistry and Haematology, Venlo, The Netherlands
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Johannes Lotz
  • Laboratory Medicine, University Medical Center, Johannes Gutenberg University Mainz, Mainz, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Karl Lackner
  • Laboratory Medicine, University Medical Center, Johannes Gutenberg University Mainz, Mainz, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Lieselotte Lennartz / David Armbruster / Gregory Maine / Paul M. Yip
  • Corresponding author
  • Department of Laboratory Medicine and Pathobiology, University Health Network and University of Toronto, Toronto, Ontario, Canada
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2014-08-07 | DOI: https://doi.org/10.1515/cclm-2014-0310

Abstract

Background: The utility of HbA1c for the diagnosis of type 2 diabetes requires an accurate, precise and robust test measurement system. Currently, immunoassay and HPLC are the most popular methods for HbA1c quantification, noting however the limitations associated with some platforms, such as imprecision or interference from common hemoglobin variants. Abbott Diagnostics has introduced a fully automated direct enzymatic method for the quantification of HbA1c from whole blood on the ARCHITECT chemistry system.

Methods: Here we completed a method evaluation of the ARCHITECT HbA1c enzymatic assay for imprecision, accuracy, method comparison, interference from hemoglobin variants and specimen stability. This was completed at three independent clinical laboratories in North America and Europe.

Results: The total imprecision ranged from 0.5% to 2.2% CV with low and high level control materials. Around the diagnostic cut-off of 48 mmol/mol, the total imprecision was 0.6% CV. Mean bias using reference samples from IFCC and CAP ranged from –1.1 to 1.0 mmol/mol. The enzymatic assay also showed excellent agreement with HPLC methods, with slopes of 1.01 and correlation coefficients ranging from 0.984 to 0.996 compared to Menarini Adams HA-8160, Bio-Rad Variant II and Variant II Turbo instruments. Finally, no significant effect was observed for erythrocyte sedimentation or interference from common hemoglobin variants in patient samples containing heterozygous HbS, HbC, HbD, HbE, and up to 10% HbF.

Conclusions: The ARCHITECT enzymatic assay for HbA1c is a robust and fully automated method that meets the performance requirements to support the diagnosis of type 2 diabetes.

Keywords: biological variation; diabetes; enzymatic assay; HbA1c; method evaluation

References

  • 1.

    American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care 2013;36(Suppl 1):S67–74.Google Scholar

  • 2.

    Canadian Diabetes Association. Clinical practice guidelines. Can J Diabetes 2013;37(Suppl 1):S1–212.Google Scholar

  • 3.

    Lenters-Westra E, Schindhelm RK, Bilo HJ, Slingerland RJ. Haemoglobin A1c: historical overview and current concepts. Diabetes Res Clin Pract 2013;99:75–84.Web of ScienceCrossrefGoogle Scholar

  • 4.

    NGSP. College of American Pathologists (CAP) GH2 survey data. 2013 Available from: http://www.ngsp.org/CAP/CAP13a.pdf. Accessed on 19 November, 2013.

  • 5.

    RfB. GH4/13 Glycated hemoglobine survey. 2013 Available from: https://www.dgkl-rfb.de/cgi/displayAnaStats?rv_type= GH&rvTypeForDetails=GH&year=2013&rv_num=4&analyte= all&searchType=rv_type&anaV=1. Accessed on 28 January, 2014.

  • 6.

    Liu L, Hood S, Wang Y, Bezverkov R, Dou C, Datta A, et al. Direct enzymatic assay for%HbA1c in human whole blood samples. Clin Biochem 2008;41:576–83.Web of ScienceCrossrefPubMedGoogle Scholar

  • 7.

    Sakurabayashi I, Watano T, Yonehara S, Ishimaru K, Hirai K, Komori T, et al. New enzymatic assay for glycohemoglobin. Clin Chem 2003;49:269–74.PubMedCrossrefGoogle Scholar

  • 8.

    Hoelzel W, Weykamp C, Jeppsson JO, Miedema K, Barr JR, Goodall I, et al. IFCC reference system for measurement of hemoglobin A1c in human blood and the national standardization schemes in the United States, Japan, and Sweden: a method-comparison study. Clin Chem 2004;50:166–74.Google Scholar

  • 9.

    Jeppsson JO, Kobold U, Barr J, Finke A, Hoelzel W, Hoshino T, et al. Approved IFCC reference method for the measurement of HbA1c in human blood. Clin Chem Lab Med 2002;40:78–89.PubMedGoogle Scholar

  • 10.

    NGSP. IFCC standardization of HbA1c. 2013. Available from: http://www.ngsp.org/ifccngsp.asp. Accessed on 19 November, 2013.

  • 11.

    CLSI. Evaluation of precision performance of quantitative measurement methods. EP05-A2. Wayne PA: Clinical and Laboratory Standards Institute, 2004.Google Scholar

  • 12.

    Lee J, Kim M, Chae H, Kim Y, Park HI, Chi H, et al. Evaluation of enzymatic BM test HbA1c on the JCA-BM6010/C and comparison with Bio-Rad Variant II Turbo, Tosoh HLC 723 G8, and AutoLab immunoturbidimetry assay. Clin Chem Lab Med 2013;51:2201–8.Google Scholar

  • 13.

    Matsumoto H, Uchino M, Kato M. Evaluation of haemoglobin A1c measurement by an enzymatic method using an automated analyser that has an on-board haemolysis system. Ann Clin Biochem 2013;50:443–9.Web of ScienceGoogle Scholar

  • 14.

    Weykamp C. HbA1c: a review of analytical and clinical aspects. Ann Lab Med 2013;33:393–400.Google Scholar

  • 15.

    Weykamp CW, Mosca A, Gillery P, Panteghini M. The analytical goals for hemoglobin A(1c) measurement in IFCC units and National Glycohemoglobin Standardization Program Units are different. Clin Chem 2011;57:1204–6.Google Scholar

  • 16.

    Sacks DB, Arnold M, Bakris GL, Bruns DE, Horvath AR, Kirkman MS, et al. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem 2011;57:e1–47.CrossrefGoogle Scholar

  • 17.

    The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977–86.Google Scholar

  • 18.

    Braga F, Dolci A, Montagnana M, Pagani F, Paleari R, Guidi GC, et al. Revaluation of biological variation of glycated hemoglobin (HbA(1c)) using an accurately designed protocol and an assay traceable to the IFCC reference system. Clin Chim Acta 2011;412:1412–6.Web of ScienceGoogle Scholar

  • 19.

    Lin CN, Emery TJ, Little RR, Hanson SE, Rohlfing CL, Jaisson S, et al. Effects of hemoglobin C, D, E, and S traits on measurements of HbA1c by six methods. Clin Chim Acta 2012;413: 819–21.Web of ScienceGoogle Scholar

  • 20.

    Nishihara E, Koga M, Kadowaki S, Murakami M, Harano K, Ito M, et al. Method-dependent HbA1c values in a family with hemoglobin Himeji. Clin Chim Acta 2011;412:1689–92.Web of ScienceGoogle Scholar

  • 21.

    Mosca A, Paleari R, Leone D, Ivaldi G. The relevance of hemoglobin F measurement in the diagnosis of thalassemias and related hemoglobinopathies. Clin Biochem 2009;42:1797–801.PubMedWeb of ScienceCrossrefGoogle Scholar

  • 22.

    Ibrahim M, Qari MH, Sait W, Abulela M. Pattern of HB F level rise during normal pregnancies. Hemoglobin 2009;33:534–8.PubMedWeb of ScienceCrossrefGoogle Scholar

  • 23.

    Little RR, Rohlfing CL, Tennill AL, Connolly S, Hanson S. Effects of sample storage conditions on glycated hemoglobin measurement: evaluation of five different high performance liquid chromatography methods. Diabetes Technol Ther 2007;9:36–42.Web of ScienceCrossrefPubMedGoogle Scholar

  • 24.

    Abbott Hemoglobin A1c (4P52-21). Package Insert. G1-0294/R02. 2014.Google Scholar

About the article

Corresponding author: Paul M. Yip, Department of Laboratory Medicine and Pathobiology, University Health Network and University of Toronto, Toronto, Ontario, Canada, E-mail:


Received: 2014-03-28

Accepted: 2014-06-16

Published Online: 2014-08-07

Published in Print: 2015-01-01


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 53, Issue 1, Pages 125–132, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2014-0310.

Export Citation

©2015 by De Gruyter.Get Permission

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]
Andrea Tesija Kuna, Kristina Dukic, Nora Nikolac Gabaj, Marijana Miler, Ines Vukasovic, Sanja Langer, Ana-Maria Simundic, and Nada Vrkic
Laboratory Medicine, 2018
[2]
Clayton R. Wilburn, David W. Bernard, Arthur W. Zieske, Julia Andrieni, Tara Miller, and Ping Wang
American Journal of Clinical Pathology, 2017, Volume 147, Number 6, Page 589
[3]
David Armbruster
Clinics in Laboratory Medicine, 2017, Volume 37, Number 1, Page 119

Comments (0)

Please log in or register to comment.
Log in