2020, Number 4
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Rev Mex Patol Clin Med Lab 2020; 67 (4)
HbA1c: Applying IFCC quality targets to Mexican laboratories
Rojano-Rodríguez E, Sierra-Amor R
Language: Spanish
References: 27
Page: 190-197
PDF size: 249.08 Kb.
ABSTRACT
For decades, the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has made great efforts and achievements in standardization of HbA1c testing. A model was developed for quality objectives for HbA1c, the IFCC task force-HbA1c proposed an initial criteria of a total allowable error of 5 mmol/mol (0.46%) at a level of two sigma. Mexican laboratories have participated in projects organized by the IFCC using samples with a target value determined by the international reference method, such as the project EurA1c of the Committee on Education in the Use of Biomarkers in Diabetes, which includes the participation of 4,000 laboratories. An evaluation of the performance of the participating Mexicans laboratories was carried out within the framework of this model to know the quality status and compared with other countries. In the results, a high variability in performance was observed, the main source of error being a relatively high imprecision. However, an improvement trend was also detected. The proposed quality objective could be achieved through education and organized participation.
REFERENCES
Diabetes Control and Complications Trial Research Group, Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O et al. 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 (14): 977-986.
Turner R, Cull C, Holman R. United Kingdom Prospective Diabetes Study 17: a 9-year update of a randomized, controlled trial on the effect of improved metabolic control on complications in non-insulin-dependent diabetes mellitus. Ann Intern Med. 1996; 124 (1 Pt 2): 136-145.
Hoelzel W, Miedema K. Development of a reference system for the international standardization of HbA1c/glycohemoglobin determinations. J Int Fed Clin Chem. 1996; 8 (2): 62-64, 66-67.
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 (5): 299-308.
Weykamp CW, Penders TJ, Muskiet FA, van der Slik W. Evaluation of a reference material for glycated haemoglobin. Eur J Clin Chem Clin Biochem. 1996; 34 (1): 67-72.
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 (1): 78-89.
Hanas R, John G; International HBA1c Consensus Committee. 2010 consensus statement on the worldwide standardization of the hemoglobin A1C measurement. Diabetes Care. 2010; 33 (8): 1903-1904.
NGSP/IFCC 2019 Manufacturers World Forum. [Accesado junio 2020] Available in: http://www.ngsp.org/docs/MF2019.pdf
Task Force on Implementation of HbA1c Standardization (Integrated Project) (TF-HbA1c). [Accesado mayo 2020] Available in: https://www.ifcc.org/executive-board-and-council/eb-task-forces/closed-task-forces/task-force-hba1c/
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 hb a1c: biological variation and sigma-metrics. Clin Chem. 2015; 61 (5): 752-759.
A new IFCC Committee on Education in the Use of Biomarkers in Diabetes. Available in: http://www.ifcc.org/ifcc-news/archive-2016/2016-01-14-c-eubd
The European Reference Laboratory for Glycohemoglobin. [Accesado junio 2020] Available in: www.euroreflab.com
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 (8): 1183-1192.
Westgard JO. Internal quality control: planning and implementation strategies. Ann Clin Biochem. 2003; 40 (Pt 6): 593-611. doi: 10.1258/000456303770367199.
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 (7): 475-476.
American Diabetes Association. 2. Classification and diagnosis of diabetes: standards of medical care in diabetes-2020. Diabetes Care. 2020; 43 (Suppl 1): S14-S31.
Little RR, Rohlfing C, Sacks DB. The National glycohemoglobin standardization program: over 20 years of improving hemoglobin A1c measurement. Clin Chem. 2019; 65 (7): 839-848.
College of American Pathologists (CAP) GH5 Survey Data: (updated 12/19). [Accesado junio 2020] Available in: http://ngsp.org/CAP/CAP19c.pdf
College of American Pathologists (CAP) GH5 Survey Data: (updated 6/19). [Accesado junio 2020] Available in: www.http://ngsp.org/CAP/CAP19a.pdf
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 (8): 1204-1246.
Kilpatrick ES. Toward a global overview of HbA1c test performance. Clin Chem. 2018; 64 (8): 1131-1132.
Westgard JF. Quality requirements and standards. [Accesado mayo 2020] Available in: https://www.westgard.com/hba1c-2014-partthree.htm
Heinemann L, Kaiser P, Freckmann G, Grote-Koska D, Kerner W, Landgraf R et al. Higher HbA1c measurement quality standards are needed for follow-up and diagnosis: experience and analyses from germany. Horm Metab Res. 2018; 50 (10): 728-734.
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 (11): 1769-1775.
Lenters-Westra E, English E. Understanding the use of sigma metrics in hemoglobin A1c analysis. Clin Lab Med. 2017; 37 (1): 57-71.
Mosca A, Paleari R, Carobene A, Weykamp C, Ceriotti F. Performance of glycated hemoglobin (HbA(1c)) methods evaluated with EQAS studies using fresh blood samples: still space for improvements. Clin Chim Acta. 2015; 451 (Pt B): 305-309.
Rojano-Rodríguez E, Acosta-González RI, Bocanegra-Alonso A, Rivera-Sánchez G, Sierra-Amor RI. Desempeño de un grupo de laboratorios mexicanos en la determinación de HbA1c. Bioquimia. 2007; 32 (3): 91-99.