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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

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1437-4331
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Volume 51, Issue 9

Issues

Standardization and analytical goals for glycated hemoglobin measurement

Federica Braga
  • Corresponding author
  • Centre for Metrological Traceability in Laboratory Medicine (CIRME), University of Milan, Milan, Italy
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Mauro Panteghini
  • Centre for Metrological Traceability in Laboratory Medicine (CIRME), University of Milan, Milan, Italy
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2013-05-13 | DOI: https://doi.org/10.1515/cclm-2013-0060

Abstract

Glycated hemoglobin (HbA1c) plays a key role in diagnosing diabetes and monitoring the glycemic state. To guarantee the reliability of its measurement at the global level, the IFCC has defined a reference measurement system, based on the definition of the measurand as hemoglobin molecules having a special hexapeptide in common, which is the stable adduct of glucose to the N-terminal valine of the hemoglobin β-chain. In addition to the traceability of HbA1c results to the reference system, the establishment of analytical goals to make HbA1c measurements clinically reliable becomes crucial. However, allowable goals will depend on the assay specificity (i.e., selectivity) and, consequently, on units in which HbA1c results are expressed [mmol/mol for IFCC-aligned systems or % for National Glycohemoglobin Standardization Program (NGSP) converted numbers]. In this regard, analytical goals derived from biological variability studies in which the determination of HbA1c has been carried out by an assay providing the same selectivity for the measurand as defined by the IFCC are recommended. Only these targets should be used for evaluating the performance of commercial assays traceable to the IFCC system and of clinical laboratories using them through appropriately structured quality assessment schemes. Analytical systems following different calibration hierarchies (e.g., the NGSP-aligned assays) will require different analytical goals, possibly derived from clinical outcome data.

Keywords: analytical goals; glycated hemoglobin; standardization

References

  • 1.

    American Diabetes Association. Standards of medical care in diabetes-2012. Diabetes Care 2012;35(Suppl 1):S11–63.Google Scholar

  • 2.

    World Health Organization. Use of glycated haemoglobin (HbA1c) in the diagnosis of diabetes mellitus: abbreviated report of a WHO consultation. 2011. WHO Available from: http://www.who.int/cardiovascular_diseases/report-hba1c_2011_edited.pdf. Accessed on April 29, 2013.

  • 3.

    Panteghini M. Application of traceability concepts to analytical quality control may reconcile total error with uncertainty of measurement. Clin Chem Lab Med 2010;48:7–10.Web of SciencePubMedGoogle Scholar

  • 4.

    Panteghini M. Implementation of standardization in clinical practice: not always an easy task. Clin Chem Lab Med 2012;50:1237–41.PubMedGoogle Scholar

  • 5.

    Mosca A, Goodall I, Hoshino T, Jeppsson JO, John WG, Little RR, et al. Global standardization of glycated hemoglobin measurement: the position of the IFCC Working Group. Clin Chem Lab Med 2007;45:1077–80.Google Scholar

  • 6.

    Weykamp C, John WG, Mosca A, Hoshino T, Little R, Jeppsson JO, et al. The IFCC reference measurement system for HbA1c: a 6-year progress report. Clin Chem 2008;54:240–8.CrossrefGoogle Scholar

  • 7.

    Little RR, Rohlfing CL, Sacks DB. Status of hemoglobin A1c measurement and goals for improvement: from chaos to order for improving diabetes care. Clin Chem 2011;57:205–14.PubMedCrossrefWeb of ScienceGoogle Scholar

  • 8.

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

  • 9.

    Nordin G, Dybkaer R. Recommendation for term and measurement unit for “HbA1c”. Clin Chem Lab Med 2007;45:1081–2.PubMedWeb of ScienceGoogle Scholar

  • 10.

    Panteghini M, John WG. Implementation of haemoglobin A1c results traceable to the IFCC reference system: the way forward. Clin Chem Lab Med 2007;45:942–4.Web of SciencePubMedGoogle Scholar

  • 11.

    Hoelzel W, Weykamp C, Jeppsson J, 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.CrossrefPubMedGoogle Scholar

  • 12.

    Geistanger A, Arends S, Berding C, Hoshino T, Jeppsson JO, Little R, et al. Statistical methods for monitoring the relationship between the IFCC reference measurement procedure for hemoglobin A1c and the designated comparison methods in the United States, Japan, and Sweden. Clin Chem 2008;54:1379–85.PubMedWeb of ScienceCrossrefGoogle Scholar

  • 13.

    Roche Diagnostics GmbH, Centralized Diagnostics Operations, Quality Operations Penzberg. Traceability and uncertainty. Cobas Integra C.f.a.s. HbA1c. March 2008.Google Scholar

  • 14.

    Braga F, Dolci A, Mosca A, Panteghini M. Biological variability of glycated hemoglobin. Chim Clin Acta 2010;411:1606–10.Web of ScienceCrossrefGoogle Scholar

  • 15.

    Panteghini M. Traceability as a unique tool to improve standardization in laboratory medicine. Clin Biochem 2009;42:236–40.PubMedCrossrefWeb of ScienceGoogle Scholar

  • 16.

    Mosca A, Branca MT, Carta M, Genna ML, Giorda CB, Ghidelli R, et al. Recommendations for the implementation of international standardization of glycated hemoglobin in Italy. Clin Chem Lab Med 2010;48:623–6.Web of SciencePubMedGoogle Scholar

  • 17.

    Kallner A, McQueen M, Heuck C. The Stockholm Consensus Conference on quality specifications in laboratory medicine, 25–26 April 1999. Scand J Clin Lab Invest 1999;59:475–585.Google Scholar

  • 18.

    Klee GG. Establishment of outcome-related analytic performance goals. Clin Chem 2010;56:714–22.Web of SciencePubMedCrossrefGoogle Scholar

  • 19.

    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

  • 20.

    Clinical and Laboratory Standards Institute (CLSI). Verification of comparability of patient results within one health care system; Proposed guideline, C54-P. Wayne, PA: CLSI, 2007.Google Scholar

  • 21.

    Fraser CG, Hyltoft Petersen P, Libeer JC, Ricos C. Proposals for setting generally applicable quality goals solely based on biology. Ann Clin Biochem 1997;34:8–12.PubMedGoogle Scholar

  • 22.

    Fraser CG, Harris EK. Generation and application of data on biological variation in clinical chemistry. Crit Rev Clin Lab Sci 1989;27:409–37.PubMedCrossrefGoogle Scholar

  • 23.

    Goodall I, Colman PG, Schneider HG, McLean M, Barker G. Desirable performance standards for HbA1c analysis – precision, accuracy and standardisation. Consensus statement of the Australasian Association of Clinical Biochemists (AACB), the Australian Diabetes Society (ADS), the Royal College of Pathologists of Australasia (RCPA), Endocrine Society of Australia (ESA), and the Australian Diabetes Educators Association (ADEA). Clin Chem Lab Med 2007;45:1083–97.PubMedGoogle Scholar

  • 24.

    Carobene A, Franzini C, Ceriotti F. Comparison of the results from two different External Quality Assessment Schemes supports the utility of robust quality specifications. Clin Chem Lab Med 2011;49:1143–9.Web of SciencePubMedGoogle Scholar

  • 25.

    Ponzo P, Dolci A, Scapellato L, Milano M, Paleari R, Mosca A, et al. Evaluation of commutability for Cobas Integra analytical system of the EQA materials for hemoglobin A1c. Biochim Clin 2008;32:44–7.Google Scholar

  • 26.

    Mosca A. Some practical advices on how to implement the international standardization of glycated hemoglobin measurement in Italy. Biochim Clin 2011;35:36–41.Google Scholar

  • 27.

    Weykamp CW, Mosca A, Gillery P, Panteghini M. The analytical goals for hemoglobin A1c measurement in IFCC units and National Glycohemoglobin Standardization Program units are different. Clin Chem 2011;57:1204–6.CrossrefPubMedGoogle Scholar

  • 28.

    Trapé J, Aliart M, Brunet M, Dern E, Abadal E, Queraltó J. Reference change value for HbA1c in patients with type 2 diabetes mellitus. Clin Chem Lab Med 2000;38:1283–7.PubMedGoogle Scholar

  • 29.

    Braga F, Dolci A, Montagnana M, Pagani F, Paleari R, Guidi GC, et al. Revaluation of biological variation of glycated hemoglobin (HbA1c) using an accurately designed protocol and an assay traceable to the IFCC reference system. Clin Chim Acta 2011;412:1412–6.PubMedCrossrefWeb of ScienceGoogle Scholar

  • 30.

    Franzini C. Need for a more correct estimate of biological variation values. Biochim Clin 2011;35:382–5.Google Scholar

  • 31.

    Braga F, Panteghini M. Biological variability of C-reactive protein: is the available information reliable? Clin Chim Acta 2012;413:1179–83.PubMedWeb of ScienceCrossrefGoogle Scholar

  • 32.

    Panteghini M. Traceability in laboratory medicine: copernican revolution or activity for a restricted professional club? 4th International Scientific Meeting “Rethinking quality control in the traceability era”. November 30, 2010, Milano, Italy. Available from: http://users.unimi.it/cirme/public/UploadAttach/Panteghini2010.pdf. Accessed on April 29, 2013.

  • 33.

    Infusino I, Braga F, Paleari R, Mosca A, Panteghini M. The Joint Committee for Traceability in Laboratory Medicine (JCTLM): a global cooperation to promote the standardisation of test results in Laboratory Medicine. Biochim Clin 2011;35:377–81.Google Scholar

  • 34.

    Carobene A, Ceriotti F, Infusino I, Frusciante E, Panteghini M. Evaluation of the impact of standardization process on the quality of serum creatinine determination in Italian laboratories. Biochim Clin 2012;37:414–24.Google Scholar

  • 35.

    Infusino I, Panteghini M. Serum albumin: accuracy and clinical use. Chim Clin Acta 2013;419:15–8.Web of ScienceGoogle Scholar

  • 36.

    Finke A, Kobold U, Hoelzel W, Weykamp C, Miedema K, Jeppsson JO. Preparation of a candidate primary reference material for the international standardisation of HbA1c determinations. Clin Chem Lab Med 1998;36:299–308.PubMedGoogle Scholar

  • 37.

    ISO 15194:2009. In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Requirements for certified reference materials and content of supporting documentation. 2nd ed. Geneva, Switzerland: ISO, 2009.Google Scholar

  • 38.

    Kaiser P, Akerboom T, Molnar P, Reinauer H. Modified HPLC electrospray ionization/mass spectrometry method for HbA1c based on IFCC reference measurement procedure. Clin Chem 2008;54:1018–22.CrossrefPubMedGoogle Scholar

  • 39.

    Kaiser P, Akerboom T, Ohlendorf R. Liquid chromatography-isotope dilution-mass spectrometry as a new basis for the reference measurement procedure for hemoglobin. Liquid chromatography-isotope dilution-mass spectrometry as a new basis for the reference measurement procedure for hemoglobin A1c determination. Clin Chem 2010;56:750–4.PubMedGoogle Scholar

  • 40.

    Bunk D. Requirements of a reference measurement procedure and how they relate to a certified reference material for cTnI that is fit for purpose. 5th International Scientific Meeting “Standardization of cardiac troponin I: the ongoing international efforts”. November 30, 2011, Milano, Italy. Available from: http://users.unimi.it/barb/public/UploadAttach/2011Bunk.pdf.

About the article

Corresponding author: Federica Braga, Centre for Metrological Traceability in Laboratory Medicine (CIRME), University of Milan, Milan, Italy, Phone: +39 0239042743, Fax: +39 0250319835


Received: 2013-01-30

Accepted: 2013-04-18

Published Online: 2013-05-13

Published in Print: 2013-09-01


Citation Information: Clinical Chemistry and Laboratory Medicine, Volume 51, Issue 9, Pages 1719–1726, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2013-0060.

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