2019, Number 1
<< Back Next >>
Rev Mex Patol Clin Med Lab 2019; 66 (1)
Correlation among two methods for glycated hemoglobin determination in diabetic Mexican patients for glycemic control
Gastélum-Cano JM, García-Alcalá H, Rodríguez-Gallegos AB, Fragoso-Flores J, Vera-Balderas AM
Language: English
References: 35
Page: 13-19
PDF size: 252.10 Kb.
ABSTRACT
Glycated hemoglobin (HbA
1c) is a molecule derived from the non-enzymatic union of glucose in the β chain of Hemoglobin (Hb) A of red blood cells proposed for the American Diabetes Association (ADA) as the best test to evaluate long term glycemic control. The precision in its determination is a very important issue. The objective of this study was to analyze correlation and to determine glycemic control classification concordance among two methods : Ion-Exchange High-performance Liquid Chromatography (IE-HPLC) and Capillary Electrophoresis (CE) using two commercial instruments. A total of 249 samples from diabetic patients (n) were tested for HbA1c by both methods. Results were analyzed by correlation, Bland-Altman scatter plots and calculating CE’s sensitivity (Sn), specificity (Sp), positive and negative predictive values (PPV and NPV) to identify glycemic control (HPLC HbA
1c ‹ 7%). The correlation was statistically significant (r = 0.9906, p ‹ 0.0001), Kappa correlation 0.959 (p ‹ 0.05); Bland-Altman plot analysis showed high level of agreement. CE Sn, SP, PPV and NPV were respectively: 98%, 98, 99% and 97%. Considerable differences in glycemic control classification were not observed. CE in Capillarys 2FP seems to be a good alternative method for HbA1c measuring for glycemic control.
REFERENCES
American Diabetes Association. Classification and diagnosis of diabetes: standards of medical care in diabetes 2018. Diabetes Care. 2018; 41: S13-S27. doi: 10.2337/dc18-S002.
Bhattacharya S, Dey D, Roy SS. Molecular mechanism of insulin resistance. J Biosci. 2007. doi: 10.1007/s12038-007-0038-8.
Zick Y. Insulin resistance: A phosphorylation-based uncoupling of insulin signaling. Trends Cell Biol. 2001. doi: 10.1016/S0962-8924(01)02129-8.
Paz K, Hemi R, LeRoith D et al. A molecular basis for insulin resistance. Elevated serine/threonine phosphorylation of IRS-1 and IRS-2 inhibits their binding to the juxtamembrane region of the insulin receptor and impairs their ability to undergo insulin-induced tyrosine phosphorylation. J Biol Chem. 1997. doi: 10.1074/jbc.272.47.29911.
American Diabetes Association. Standards of Medical Care in Diabetes-2018 Abridged for Primary Care Providers. J Clin Appl Res Educ. 2018; 41 (Supplement 1): S1-S159. doi: 10.2337/dc13-S011.
Vijan S. Type 2 diabetes. Ann Intern Med. 2010. doi: 10.7326/0003-4819-152-5-201003020-01003.
Gutiérrez JP, Rivera-Dommarco JA, Shamah-Levy T et al. Encuesta Nacional de Salud y Nutrición 2012. Resultados Nacionales. 2a. ed. Inst Nac Salud Publica. 2013. doi: 10.4206/agrosur.1974.v2n2-09.
Herrington WG, Alegre-Díaz J, Wade R et al. Effect of diabetes duration and glycaemic control on 14-year cause-specific mortality in Mexican adults: a blood-based prospective cohort study. Lancet Diabetes Endocrinol. 2018; 6 (6): 455-463. doi: 10.1016/S2213-8587(18)30050-0.
Sattar N, Preiss D. HbA1cin type 2 diabetes diagnostic criteria: addressing the right questions to move the field forwards. Diabetología. 2012; 55 (6): 1564-1567. doi: 10.1007/s00125-012-2510-8.
Shapiro R, McManus MJ, Zalut C, Bunn HF. Sites of nonenzymatic glycosylation of human hemoglobin A. J Biol Chem. 1980; 255 (7): 3120-3127.
Penttilä I, Penttilä K, Holm P et al. Methods, units and quality requirements for the analysis of haemoglobin A 1c in diabetes mellitus. World J Methodol. 2016; 6 (2): 133. doi: 10.5662/wjm.v6.i2.133.
Jeppsson J-O, Kobold U, Barr J et al. Approved IFCC reference method for the measurement of HbA1c in human blood. Clin Chem Lab Med. 2002; 40 (1): 78-89. doi: 10.1515/CCLM.2002.016.
Rhea JM, Molinaro R. Pathology consultation on HbA1c methods and interferences. Am J Clin Pathol. 2014; 141 (1): 5-16. doi: 10.1309/AJCPQ23GTTMLAEVL.
Herpol M, Lanckmans K, Van Neyghem S et al. Evaluation of the Sebia Capillarys 3 Tera and the Bio-Rad D-100 systems for the measurement of hemoglobin A1c. Am J Clin Pathol. 2016; 146 (1): 67-77. doi: 10.1093/ajcp/aqw081.
Dessi M, Pieri M, Pignalosa S, Martino FG, Zenobi R. Performances of capillary electrophoresis and HPLC methods in HbA1c determination: diagnostic accuracy in HbS and HbD-Iran variants’ presence. J Clin Lab Anal. 2015; 29 (1): 57-60. doi: 10.1002/jcla.21728.
Klingenberg O, Furuset T, Hestbråten CR et al. HbA1c analysis by capillary electrophoresis–comparison with chromatography and an immunological method. Scand J Clin Lab Invest. 2017; 77 (6): 458-464. doi: 10.1080/00365513.2017.1338747.
Wu X, Chao Y, Wan Z et al. A comparative evaluation of the analytical performances of Capillarys 2 flex piercing, tosoh HLC-723 G8, premier Hb9210, and roche cobas c501 tina-quant gen 2 analyzers for HbA1cdetermination. Biochem Medica. 2016; 26 (3): 353-364. doi: 10.11613/BM.2016.039.
Lin CN, Emery TJ, Little RR, et al. Effects of hemoglobin C, D, E, and S traits on measurements of HbA 1c by six methods. Clin Chim Acta. 2012; 413 (7-8): 819-821. doi: 10.1016/j.cca.2011.12.019.
Urrechaga E. High-resolution HbA 1c separation and hemoglobinopathy detection with capillary electrophoresis. Am J Clin Pathol. 2012; 138 (3): 448-456. doi: 10.1309/AJCPVYW9QZ9EVFXI.
Cobián JG, Sánchez-López JY, Magaña MT, Chávez ML, Perea FJ, Ibarra B. Types and frequencies of hemoglobin disorders in the pacific coast of four states of Mexico. Rev Investig Clin. 2009.
Ruiz-Reyes G. Abnormal hemoglobins and thalassemias in Mexico. Rev Invest Clin. 1998.
National Glycohemoglobin Standardization Program (NGSP). HbA1c Assay Interferences. [Accessed 5 November 2018] http://www.ngsp.org/interf.asp.
Chandrashekar V. Hb A1c Separation by high performance liquid chromatography in hemoglobinopathies. Scientifica (Cairo). 2016; 2016: 1-5. doi: 10.1155/2016/2698362.
Little RR, La’Ulu SL, Hanson SE, Rohlfing CL, Schmidt RL. Effects of 49 different rare Hb variants on HbA1c measurement in eight methods. J Diabetes Sci Technol. 2015; 9 (4): 849-856. doi: 10.1177/1932296815572367.
Gupta M, Datta P, Rao P. Haemoglobin hope: a rare Hb variant causing spuriously elevated HbA1c Values on HPLC Assay. 2016: 1-3. doi: 10.7860/NJLM/2016/14873.
Chakraborty S, Chanda D, Gain M, Krishnan P. Interference of the hope hemoglobin with hemoglobin A1c results. Lab Med. 2015; 46 (3): 221-225. doi: 10.1309/LME82XNY6SYVWDYQ.
Dimeski G, Pretorius CJ, Russell AW, Miller SP, Bird RJ, Ungerer JPJ. A case of discordant HbA1c: A method-dependent error. Med J Aust. 2009; 191 (6): 347-349. doi: dim10266_fm [pii].
Kim, Jong Taek Winter E. William, Hong-yuan Luo, Chui David HN. Interference of hemoglobin A1c due to hemoglobin franklin park. J Appl Lab Med. 2018; 03 (05): 1-3.
Sebia. Capillarys Hb A1c Using the Capillarys 2 flex-piercing instrument.
Jaisson S, Leroy N, Meurice J. First evaluation of Capillarys 2 Flex Piercing® (Sebia) as a new analyzer for HbA1c assay by Capillary electrophoresis. Clin Chem Lab Med. 2012; 50 (10): 1769-1775. doi: 10.1515/cclm-2012-0017.
Baroncini D, Zaffaroni M, Moiola L et al. Long-term follow-up of pediatric MS patients starting treatment with injectable first-line agents: A multicentre, Italian, retrospective, observational study. Mult Scler J. 2018: 1-9. doi: 10.1177/1352458518754364.
Urrechaga E. High-resolution HbA1cseparation and hemoglobinopathy detection with capillary electrophoresis. Am J Clin Pathol. 2012; 138 (3): 448-456. doi:10.1309/AJCPVYW9QZ9EVFXI.
Food and Drugs Administration. Decision Memorandum Assay and Instrument Combination Template k161681. [Accessed January 19, 2019] https://www.accessdata.fda.gov/cdrh_docs/reviews/K161687.pdf.
Marzullo C, Minery M. abc Évaluation de l’analyseur D10® pour le dosage. 2008; 66 (1): 95-99.
Food and Drugs Administration. Decision Memorandum Assay and Instrument Combination Template k171861. [Accessed January 19, 2019] https://www.accessdata.fda.gov/cdrh_docs/reviews/K171861.pdf.