932
Views
26
CrossRef citations to date
0
Altmetric
Review Article

HbA1c method performance: The great success story of global standardization

&
Pages 408-419 | Received 06 Mar 2018, Accepted 18 May 2018, Published online: 12 Jul 2018

References

  • Cho NH, Shaw JE, Karuranga S, et al. Diabetes Res Clin Pract. 2018;138:271–281.
  • American Association of Clinical Endocrinologists Board of D, American College of Endocrinologists Board of T. American Association of Clinical Endocrinologists/American College of Endocrinology statement on the use of hemoglobin A1c for the diagnosis of diabetes. Endocr Pract. 2010;16:155–156.
  • Organization WH. Use of glycated haemoglobin (HbA1c) in the diagnosis of diabetes mellitus. abbreviated report of a WHO consultation. Geneva: World Health Organization; 2011.
  • John WG. Diabetes UKDoHACo. Use of HbA1c in the diagnosis of diabetes mellitus in the UK. The implementation of World Health Organization guidance 2011. Diabet Med. 2012;29:1350–1357.
  • 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;329:977–986.
  • Nathan DM, Cleary PA, Backlund JY, et al. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005;353:2643–2653.
  • UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352:837–853.
  • Holman RR, Paul SK, Bethel MA, et al. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008;359:1577–1589.
  • Duckworth WC, Abraira C, Moritz TE, et al. The duration of diabetes affects the response to intensive glucose control in type 2 subjects: the VA Diabetes Trial. J Diabetes Complications. 2011;25:355–361.
  • Gerstein HC, Miller ME, Byington RP, et al. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008;358:2545–2559.
  • Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373:2117–2128.
  • Hayward RA, Reaven PD, Wiitala WL, et al. Follow-up of glycemic control and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2015;372:2197–2206.
  • Duckworth W, Abraira C, Moritz T, et al. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med. 2009;360:129–139.
  • Group AC, Patel A, MacMahon S, et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008;358:2560–2572.
  • Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375:311–322.
  • Dormandy JA, Charbonnel B, Eckland DJ, et al. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet. 2005;366:1279–1289.
  • Inzucchi SE, Bergenstal RM, Buse JB, 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. Dia Care. 2015;38:140–149.
  • Weykamp CW, Mosca A, Gillery P, et al. The analytical goals for hemoglobin A(1c) measurement in IFCC units and National Glycohemoglobin Standardization Program Units are different. Clin Chem. 2011;57:1204–1206.
  • Fraser CG, Petersen PH. Analytical performance characteristics should be judged against objective quality specifications. Clin Chem. 1999;45:321–323.
  • Gill JP, Shephard MD. The conduct of quality control and quality assurance testing for PoCT outside the laboratory. Clin Biochem Rev. 2010;31:85–88.
  • Sacks DB, Arnold M, Bakris GL, et al. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem. 2011;57:e1–e47.
  • Weykamp C, John G, Gillery P, et al. Investigation of 2 models to set and evaluate quality targets for hb a1c: biological variation and sigma-metrics. Clin Chem. 2015;61:752–759.
  • DG B. Quality control and quality assurance in point-of-care testing. In: CP SJA, Hicks JM, editor. Point-of-care testing. 2nd ed. Washington (DC): AACC Press; 2004. p. 137–45.
  • Martin CL. Quality control issues in point of care testing. Clin Biochem Rev. 2008;29(1):S79–S82.
  • Miller WG, Myers GL, Gantzer ML, et al. Roadmap for harmonization of clinical laboratory measurement procedures. Clin Chem. 2011;57:1108–1117.
  • Khera PK, Smith EP, Lindsell CJ, et al. Use of an oral stable isotope label to confirm variation in red blood cell mean age that influences HbA1c interpretation. Am J Hematol. 2015;90:50–55.
  • Jaisson S, Leroy N, Meurice J, et al. First evaluation of Capillarys 2 Flex Piercing® (Sebia) as a new analyzer for HbA1c assay by capillary electrophoresis. Clin Chem Lab Med. 2012;50:1769–1775.
  • John WG, Little R, Sacks DB, et al. Multicentre evaluation of the Premier Hb9210 HbA1c analyser. Clin Chem Lab Med. 2015;53:319–327.
  • Fleming JK. Evaluation of HbA1c on the Roche COBAS Integra 800 closed tube system. Clin Biochem. 2007;40:822–827.
  • Lenters-Westra E, English E. Evaluating new HbA1c methods for adoption by the IFCC and NGSP reference networks using international quality targets. Clin Chem Lab Med. 1426;55:34.
  • Little RR, Roberts WL. A review of variant hemoglobins interfering with hemoglobin A1c measurement. J Diabetes Sci Technol. 2009;3:446–451.
  • Weykamp CW, Penders TJ, Muskiet FA, et al. Influence of hemoglobin variants and derivatives on glycohemoglobin determinations, as investigated by 102 laboratories using 16 methods. Clin Chem. 1993;39:1717–1723.
  • Rohlfing CL, Connolly SM, England JD, et al. The effect of elevated fetal hemoglobin on hemoglobin A1c results: five common hemoglobin A1c methods compared with the IFCC reference method. Am J Clin Pathol. 2008;129:811–814.
  • NGSP. HbA1c Assay Interferences 2017. Available from: http://www.ngsp.org/interf.asp
  • Institute CLS. Evaluation of precision performance of clinical chemistry devices; Approved guideline. NCCLS Document EP05-A. Wayne (PA): CLSI; 1992.
  • Institute CaLS. Method comparison and bias estimation using patient samples; approved guideline. CLSI Document EP09-A. Wayne (PA): CLSI; 1995.
  • Institute CaLS. Evaluation of the linearity of quantitative measurement procedures: a statistical approach; approved guideline. CLSI Document EP06-a. Wayne (PA): CLSIe; 2003.
  • Kaiser P, Spannagl M, van Campenhout C, et al. HbA1c: EQA in Germany, Belgium and the Netherlands using fresh whole blood samples with target values assigned with the IFCC reference system. Clin Chem Lab Med. 2016;54:1769–1775.
  • Mosca A, Paleari R, Carobene A, et al. Performance of glycated hemoglobin (HbA(1c)) methods evaluated with EQAS studies using fresh blood samples: Still space for improvements. Clin Chim Acta. 2015;451:305–309.
  • Thelen MHM, Jansen RTP, Weykamp CW, et al. Expressing analytical performance from multi-sample evaluation in laboratory EQA. Clin Chem Lab Med. 2017;55:1509–1516.
  • Weykamp C, Siebelder C. Evaluation of performance of laboratories and manufacturers within the framework of the IFCC model for quality targets of HbA1c. J Diabetes Sci Technol. 2017;193229681774132.
  • Biochemists AAoC.PoCT. 2016. [04/05/16]. Available from: http://www.aacb.asn.au/resources/poct
  • Lenters-Westra E, Slingerland RJ. Six of eight hemoglobin A1c point-of-care instruments do not meet the general accepted analytical performance criteria. Clin Chem. 2010;56:44–52.
  • Lenters-Westra E, Slingerland RJ. Three of 7 hemoglobin A1c point-of-care instruments do not meet generally accepted analytical performance criteria. Clin Chem. 2014;60:1062–1072.
  • Schaffert L, English E, Heneghan C, et al. 2016. Horizon Scan 0044 Point-of-Care HbA1c tests - diagnosis of diabetes Oxford2016. Available from: http://www.oxford.dec.nihr.ac.uk/reports-and-resources/horizon-scanning-reports/point-of-care-hba1c-tests-diagnosis-of-diabetes
  • Hirst JA, McLellan JH, Price CP, et al. Performance of point-of-care HbA1c test devices: implications for use in clinical practice - a systematic review and meta-analysis. Clin Chem Lab Med. 2017;55:167–180.
  • Misra S, John WG, Alberti G, et al. The use of POCT HbA1c devices in the NHS Diabetes Prevention Programme: recommendations from an expert working group commissioned by NHS England, NHS (Commissioned report). NHS England, 2016.
  • Hub ESIRMM. Catalogue of reference materials. 2016. Available from: https://ec.europa.eu/jrc/sites/jrcsh/files/rm_catalogue_0.pdf
  • John WG. Glycated haemoglobin analyses–assessment of within- and between-laboratory performance in a large UK region. Ann Clin Biochem. 1987;24:453–460.
  • Peterson CM, Jovanovic L, Raskin P, et al. A comparative evaluation of glycosylated haemoglobin assays: feasibility of references and standards. Diabetologia. 1984;26:214–217.
  • The DCCT Research Group. Feasibility of centralized measurements of glycated hemoglobin in the Diabetes Control and Complications Trial: a multicenter study. Clin Chem. 1987;33:2267–2271.
  • Little RR, Rohlfing CL, Wiedmeyer HM, et al. The national glycohemoglobin standardization program: a five-year progress report. Clin Chem. 2001;47:1985–1992.
  • NGSP Network Laboratory Members. 2016. Available from: http://http://www.ngsp.org/network.asp
  • College of American Pathology External Quality Scheme for HbA1c. 2016. [December 2016]. Available from: http://www.ngsp.org/CAP/CAP16c.pdf
  • Shima K, Endo J, Oimomi M, et al. Interlaboratory difference in GHb measurement in Japan. The fifth report of the GHb standardization committee, the Japan diabetes society. J Japan Diab Soc. 1998;41:317–323.
  • Jeppsson JO, Jerntorp P, Sundkvist G, et al. Measurement of hemoglobin A1c by a new liquid-chromatographic assay: methodology, clinical utility, and relation to glucose tolerance evaluated. Clin Chem. 1986;32:1867–1872.
  • Tominaga M, Makino H, Yoshino G, et al. Japanese standard reference material for JDS Lot 2 haemoglobin A1c. I: Comparison of Japan Diabetes Society-assigned values to those obtained by the Japanese and USA domestic standardization programmes and by the International Federation of Clinical Chemistry reference laboratories. Ann Clin Biochem. 2005;42:41–46.
  • Seino Y, Nanjo K, Tajima N, et al. Report of the committee on the classification and diagnostic criteria of diabetes mellitus. J Diabetes Investig. 2010;1:212–228.
  • Standardization IOf. ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems. Available from: https://www.iso.org/committee/54916.html
  • Jeppsson JO, Kobold U, Barr J, et al. Approved IFCC reference method for the measurement of HbA(1c) in human blood. Clin Chem Lab Med. 2002;40:78–89.
  • Approved laboratories of the IFCC network laboratories for HbA1c. 2016. [December 2016]. Available from: www.ifcchba1c.net/network/approved
  • Weykamp C, John WG, Mosca A, et al. The IFCC reference measurement system for HbA1c: a 6-year progress report. Clin Chem. 2008;54:240–248.
  • Kilpatrick ES, Rigby AS, Atkin SL, et al. Glycemic control in the 12 months following a change to SI hemoglobin A1c reporting units. Clin Chem. 2013;59:1457–1460.
  • Geistanger A, Arends S, Berding C, 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;54:1379–1385.
  • Hoelzel W, Weykamp C, Jeppsson JO, 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;50:166–174.
  • NGSP. Convert between NGSP, IFCC and eAG. 2010. Available from: http://www.ngsp.org/convert1.asp
  • International Federation Of Clinical C, Laboratory Medicine ISD, Nordin G. Dybkaer R. Recommendation for term and measurement unit for “HbA1c”. Clin Chem Lab Med. 2007;45:1081–1082.
  • Lenters-Westra EE. Understanding the use of sigma metrics in hemoglobin A1c analysis. Clin Lab Med. 2016;37:57–71.
  • Hanas R, John G, International Hb ACC. 2010 consensus statement on the worldwide standardization of the hemoglobin A1c measurement. Clin Chem. 2010;56:1362–1364.
  • Borg R, Kuenen JC, Carstensen B, et al. Associations between features of glucose exposure and A1C: the A1C-Derived Average Glucose (ADAG) study. Diabetes. 2010;59:1585–1590.
  • Malka R, Nathan DM, Higgins JM. Mechanistic modeling of hemoglobin glycation and red blood cell kinetics enables personalized diabetes monitoring. Sci Transl Med. 2016;8:359ra130.
  • English E, Idris I, Smith G, et al. The effect of anaemia and abnormalities of erythrocyte indices on HbA1c analysis: a systematic review. Diabetologia. 2015;58:1409–1421.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.