Advanced Biomedical Research

Comparative evaluation of three different methods for HbA 1c measurement with High-performance liquid chromatography in diabetic patients

Authors

Department of Pathology, Isfahan University of Medial Science, Iran

Abstract

Background: The global prevalence of diabetes mellitus is increasing rapidly. Measurement of glycated hemoglobin, predominantly HbA 1c , is fundamental to the management of patients with diabetes. HbA 1c is used to monitor long-term glycemic control, adjust therapy, assess the quality of diabetes care and predict the risk for the development of complications. While HbA 1c is the standard method for long-term glycemic control in diabetic patients, there are different methods for measurement of HbA 1c and all laboratories do not use the reference method (high-performance liquid chromatography [HPLC]).The objective of this study is comparison of three different methods with HPLC to find out which method has an acceptable concordance and correlation with the reference method.
Materials and Methods: Fifty-eight diabetic patients were assessed in this study. The blood sample of each patient was checked with Diazyme (enzymatic assay), Nycocard (boronate-affinity binding) and Biosystem (micro column chromatography). The values of HbA 1c of each method were compared with the Knauer-HPLC results.
Results: The means of the differential values between each method and HPLC in the ANOVA test are as follows: M = 1.8, SD = 1.09 for Nycocard-HPLC; M = 1.5, SD = 1.08 for biosystem-HPLC; M = 1.3, SD = 1.2 for Diazyme-HPLC. Pearson's correlation coefficient between HPLC and Nycocard; 0.76, HPLC and Diazyme; 0.75 and between HPLC and Biosystem was 0.68. Linear regression parameters for each method with HPLC were also determined.
Conclusion: Diazyme had a better performance and showed a greater concordance with HPLC among others, although it was not an ideal alternative for HPLC.

Keywords

1.Syed IA. Glycated haemoglobin; past, present, and future are we ready for the change. J Pak Med Assoc 2011; 61:383-8.  Back to cited text no. 1
[PUBMED]    2.Assadi F. The epidemic of pediatric chronic kidney disease the danger of skepticism. J Nephropathol 2012;1:61-4.  Back to cited text no. 2
[PUBMED]    3.Bry?kiewicz ME, Majkowska L. Glycated hemoglobin (HbA1c) as a standard diagnostic criterium for diabetes? Pol Merkur Lekarski 2011;30:150-4.  Back to cited text no. 3
    4.Gheissari A, Mehrasa P, Merrikhi A, Madihi Y. Acute kidney injury: A pediatric experience over 10 years at a tertiary care center. J Nephropathol 2012;1:101-8.  Back to cited text no. 4
[PUBMED]    5.Bry?kiewicz ME, Majkowska L. Aspects of the standardization of glycated hemoglobin (HbA1c) measurement. Pol Merkur Lekarski 2011; 30:155-9.  Back to cited text no. 5
    6.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;40:78-89.  Back to cited text no. 6
    7.Gaborit B, Nicolay A, Valéro R, Bégu A, Badens C, Bellanné-Chantelot C, et al. Comparison of performances of various HbA1c methods in Haemoglobin Camperdown variant detection: Consequences in diabetes management. Clin Chim Acta 2009;403:262-3.  Back to cited text no. 7
    8.Klenk DC, Hermanson GT, Krohn RI, Fujimoto EK, Mallia AK, Smith PK, et al. Determination of glycosylated hemoglobin by affinity chromatography: Comparison with colorimetric and ion-exchange methods, and effects of common interferences. Clin Chem 1982;28:2088-94.  Back to cited text no. 8
[PUBMED]    9.John WG. Glycated haemoglobin analyses--assessment of within- and between-laboratory performance in a large UK region. Ann Clin Biochem 1987;24:453-60.  Back to cited text no. 9
[PUBMED]    10.Shapiro DE. The interpretation of diagnostic tests. Stat Methods Med Res 1999;8:113-34.  Back to cited text no. 10
[PUBMED]    11.Bodor GS, Little RR, Garrett N, Brown W, Goldstein DE, Nahm H. Standardization of glycohemoglobin determinations in the clinical laboratory: Three years of experience. Clin Chem 1992;38:2414-8.  Back to cited text no. 11
    12.Reinauer H. Biochemistry of protein glycation in diabetes mellitus. Klin Lab 1993;39:984-7.  Back to cited text no. 12
    13.Peterson KP, Pavlovich JG, Goldstein D, Little R, England J, Peterson CM. What is hemoglobin A1c? An analysis of glycated hemoglobins by electrospray ionization mass spectrometry. Clin Chem 1998;44:1951-8.  Back to cited text no. 13
    14.Roberts NB, Amara AB, Morris M, Green BN. Long-term evaluation of electrospray ionization mass spectrometric analysis of glycated hemoglobin. Clin Chem 2001;47:316-21.  Back to cited text no. 14
    15.Weykamp CW, Penders TJ, Muskiet FA, van der Slik W. Effect of calibration on dispersion of glycohemoglobin values determined by 111 laboratories using 21 methods. Clin Chem 1994;40:138-44.  Back to cited text no. 15
    16.James Westgard Founder; Biological variation database specifications. 2010. Available from: http://www.westgard.com/biodatabase1.htm. [Last accessed on April 6, 2013]  Back to cited text no. 16
    17.Hollander P, Spellman C.Controversies in prediabetes: do we have a diagnosis? Postgrad Med 2012;124:109-18.  Back to cited text no. 17
    18.Tayebi Khosroshahi H. Short history about renal transplantation program in Iran and the world: Special focus on world kidney day 2012. J Nephropathol 2012;1:5-10.  Back to cited text no. 18
[PUBMED]    19.Einollahi B. Are acquired cystic kidney disease and autosomal dominant polycystic kidney disease risk factors for renal cell carcinoma in kidney transplant patients? J Nephropathol 2012;1:65-8.  Back to cited text no. 19
[PUBMED]    20.Goldberg RB, Mather K. Targeting the consequences of the metabolic syndrome in the diabetes prevention program. Arterioscler Thromb Vasc Biol 2012;32:2077-90.  Back to cited text no. 20
    21.Tolou-Ghamari Z. Nephro and neurotoxicity, mechanisms of rejection: A review on Tacrolimus and Cyclosporin in organ transplantation. J Nephropathol 2012;1:23-30.  Back to cited text no. 21
[PUBMED]    22.Fujimoto WY, Boyko EJ, Hayashi T, Kahn SE, Leonetti DL, McNeely MJ, et al. Risk Factors for Type 2 Diabetes: Lessons Learned from Japanese Americans in Seattle. J Diabetes Investig 2012;3:212-24.  Back to cited text no. 22
    23.Khajehdehi P. Turmeric: Reemerging of a neglected Asian traditional remedy. J Nephropathol 2012;1:17-22.  Back to cited text no. 23
[PUBMED]    24.Hoelzel W, Miedema K. Development of a reference system for the international standardisation of HbA1c/glycohemoglobin determinations. J Int Fed Clin Chem 1996;9:62-4, 66-7.  Back to cited text no. 24
    25.Halwachs-Baumann G, Katzensteiner S, Schnedl W, Pürstner P, Pieber T, Wilders-Truschnig M. Comparative evaluation of three assay systems for automated determination of hemoglobin A1c. Clin Chem 1997;43:511-7.  Back to cited text no. 25
    26.Turpeinen U, Karjalainen U, Stenman UH. Three assays for glycohemoglobin compared. Clin Chem 1995;41:191-5.  Back to cited text no. 26
    27.Hawkins RC. Comparison of four point-of-care HbA1c analytical systems against central laboratory analysis. Singapore Med J 2003;44:8-11.  Back to cited text no. 27
[PUBMED]    
Advanced Biomedical Research
Volume 2014, March
March 2014
Pages 1-5