World Health Organization. Global report on diabetes. 2016.Google Scholar
Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, et al. Association of glycaemia with macrovascular and microvasular complications of type 2 diabetes (UKPDS 35): prospective observational study. Br Med J 2000;321:405–12.CrossrefGoogle Scholar
The Diabetes Control and Complications Trial Research Group (DCCT). The relationship of glycemic exposure (HbA1c) to the risk of development and progression of retinopathy in the diabetes control and complications trial. Diabetes 1995;44:968–83.PubMedGoogle Scholar
Peterson KP, Pavlovich JG, Goldstein D, Little R, England J, Peterson CM, et al. What is hemoglobin A1c? An analysis of glycated hemoglobins by electrospray ionization mass spectrometry. Clin Chem 1998;44:1951–8.PubMedGoogle Scholar
Miller WG, Jones GR, Horowitz GL, Weykamp C. Proficiency testing/external quality assessment: current challenges and future directions. Clin Chem 2011;57:1670–80.CrossrefPubMedWeb of ScienceGoogle Scholar
Delatour V, Liu Q, Vesper HW. Commutability assessment of external quality assessment materials with the difference in bias approach: are acceptance criteria based on medical requirements too strict? Clin Chem 2016;62:1670–1.Web of SciencePubMedGoogle Scholar
Joint Committee for Guides in Metrology (JCGM). JCGM 200: 2012 International vocabulary of metrology – basic and general concepts and associated terms (VIM) – 3rd edition. 2012.Google Scholar
Myers GL, Eckfeldt JH, Greenberg N, Levine JB, Miller WG, WiebeDA. CLSI C37-A: National Committee for Clinical Laboratory Standards. Preparation and validation of commutable frozen human serum pools as secondary reference materials for cholesterol measurements procedures; approved guideline. Wayne, PA: NCCLS Document C37-A 1999 NCCLS, 1999.Google Scholar
Agence nationale de sécurité du médicament. Annales du contrôle national de qualité des analyses de biologie médicale – 15BIO1 – HbA1c. 2015.Google Scholar
INSTAND e.V. – Ringversuchsprogramm [Internet]. [cited 2019 April 29]. Available from: https://www.instand-ev.de/en/eqas/eqa-program.html.
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.PubMedCrossrefGoogle Scholar
Jeppsson J, Kobold U, Barr J, Hoelzel W, Hoshino T, Miedema K, et al. Approved IFCC reference method for the measurement of HbA1c in human blood. Clin Chem Lab Med 2002;35:78–89.Google Scholar
Hoelzel W, Weykamp C, Jeppsson J-O, 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 unites States, Japan, and Sweden: a method-comparison study. Clin Chem 2004;50:166–74.CrossrefGoogle Scholar
Miller WG, Schimmel H, Rej R, Greenberg N, Ceriotti F, Burns C, et al. IFCC working group recommendations for assessing commutability. Part 1: general experimental design. Clin Chem 2018;64:447–54.CrossrefWeb of ScienceGoogle Scholar
Nilsson G, Budd JR, Greenberg N, Delatour V, Rej R, Panteghini M, et al. IFCC Working Group Recommendations for Assessing Commutability. Part 2: using the difference in bias between a reference material and clinical samples. Clin Chem 2018;64:455–64.Web of ScienceCrossrefGoogle Scholar
Korzun WJ, Nilsson G, Bachmann LM, Myers GL, Sakurabayashi I, Nakajima K, et al. Difference in bias approach for commutability assessment: application to frozen pools of human serum measured by 8 direct methods for HDL and LDL cholesterol. Clin Chem 2015;61:1107–13.CrossrefPubMedWeb of ScienceGoogle Scholar
Desirable Biological Variation Database Specifications – Westgard [Internet]. [cited 2019 April 29]. Available from: https://www.westgard.com/biodatabase1.htm.
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.PubMedCrossrefGoogle Scholar
Kaiser P, Spannagl M, Van Campenhout C, Lenga Y, Siebelder C, Weykamp C. 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;54:1769–75.PubMedGoogle Scholar
Liu H, Wong L, Yong S, Liu Q, Teo TL, Lee TK, et al. Commutable whole blood reference materials for hemoglobin A1c validated on multiple clinical analyzers. Clin Chem Lab Med 2019;57:648–58.CrossrefPubMedGoogle Scholar
Weykamp C, John WG, English E, Erasmus RT, Sacks DB, on behalf of the EurA1c Trial Group. EurA1c: the European HbA1c trial to investigate the performance of HbA1c assays in 2166 laboratories across 17 countries and 24 manufacturers by use of the IFCC model for quality targets. Clin Chem 2018;64:1183–92.Web of ScienceCrossrefPubMedGoogle Scholar
Mosca A, Paleari R, Carobene A, Weykamp C, Ceriotti F. Performance of glycated hemoglobin (HbA1c) methods evaluated with EQAS studies using fresh blood samples: still space for improvements. Clin Chim Acta 2015;451:305–9.PubMedCrossrefGoogle Scholar
About the article
Published Online: 2019-05-14
Published in Print: 2019-09-25
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
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.