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Exp Clin Endocrinol Diabetes 2017; 125(10): 655-660
DOI: 10.1055/s-0043-118535
Article
© Georg Thieme Verlag KG Stuttgart · New York

Evaluation of the Interference of Hemoglobin Variant J-Bangkok on Glycated Hemoglobin (HbA1c) Measurement by Five Different Methods

Dong-Mei Wen   *
1   Laboratory Medicine Centre, Zhongshan Hospital Affiliated to Sun Yat-sen University, Zhongshan, China
,
Sheng-Nan Xu   *
1   Laboratory Medicine Centre, Zhongshan Hospital Affiliated to Sun Yat-sen University, Zhongshan, China
,
Wei-Jia Wang
1   Laboratory Medicine Centre, Zhongshan Hospital Affiliated to Sun Yat-sen University, Zhongshan, China
,
Xiu-Ming Zhang
2   Laboratory Medicine Centre, Shenzhen Luohu People’s Hospital, Shenzhen, China
,
Ming-Huan Suo
1   Laboratory Medicine Centre, Zhongshan Hospital Affiliated to Sun Yat-sen University, Zhongshan, China
,
De-Cai Zhang
1   Laboratory Medicine Centre, Zhongshan Hospital Affiliated to Sun Yat-sen University, Zhongshan, China
› Author Affiliations
Further Information

Publication History

received 18 January 2017
revised 16 August 2017

accepted 17 August 2017

Publication Date:
20 September 2017 (online)

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Abstract

Objective The interference of the hemoglobin variant (Hb J-Bangkok) was evaluated on 4 different glycated hemoglobin assays and compared with a reference immuno assay.

Methods An overall test of coincidence of 2 least-squares linear regression lines was performed to determine whether the presence of Hb J-Bangkok caused a statistically significant difference in HbA1c results compared with a reference immuno assay. Statistical analysis was performed on the difference of the estimated average glucose calculated from HbA1c values and fasting plasma glucose in the Hb J-Bangkok variant group using the different detection systems. Deming regression analysis was used to determinate whether Hb J-Bangkok had a significant interference on HbA1c results using an HbA1c±10% relative bias at 6% and 9% HbA1c as evaluation limits.

Results Turbidimetric inhibition immunoassay method, and enzymatic methods were not affected by Hb J-Bangkok. However, Hb J-Bangkok showed statistically significant interference to the two ion-exchange high-performance liquid chromatography methods.

Conclusion When performing HbA1c tests, clinical laboratory personnel should identify the Hb variant and select the appropriate methods or use alternative indicators.

Key words

hemoglobin variant - Hb J-Bangkok - glycated hemoglobin - HbA1c - interference

* Dong-Mei Wen and Sheng-Nan Xu contributed equally to this article.


 

  • References

  • 1 American Diabetes Association. Standards of medical care in diabetes. Diabet Care 2014; 37 Suppl S5-S13
    CrossrefPubMedGoogle Scholar
  • 2 Sacks DB, Bruns DE, Goldstein DE. et al. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem 2002; 48: 436-472
    CrossrefPubMedGoogle Scholar
  • 3 Website ofWorld Health Organization. Use of Glycated haemoglobin (HbA1c) in the diagnosis of diabetes mellitus, WHO, 2011 25. [available at www.who.int/diabetes/publications/report-hba1c.2011.pdf accessed April 15 2015]
    PubMed
  • 4 Higgins T. HbA1c for screening and diagnosis of diabetes mellitus. Endocrine 2013; 43: 266-273
    CrossrefPubMedGoogle Scholar
  • 5 Rhea JM, Koch D, Ritchie J. et al. Unintended reporting of misleading HbA1c values when using assays incapable of detecting hemoglobin variants. Arch Pathol Lab Med 2013; 137: 1788-1791
    CrossrefPubMedGoogle Scholar
  • 6 Wiwanitkit V. Problem of using hemoglobin A1c measurement in endemic area of hemoglobinopathy. Prim Cae Diabete 2007; 1: 173-175
    PubMedGoogle Scholar
  • 7 Lee ST, Kim MS, Choi DY. et al. Incidence of variant hemoglobin (Hb) and increased fetal Hb concentrations and their effect on HbA1c measurement in a Korean population. Clin Chem 2006; 52: 1445-1446
    CrossrefPubMedGoogle Scholar
  • 8 Schnedl WJ, Krause R, Wallner SJ. et al. Effect of silent hemoglobin variants on A1c measurement with the IFCC reference method and 6 routine methods. Clin Chim Acta 2008; 398: 161-162
    CrossrefPubMedGoogle Scholar
  • 9 Little RR, Roberts WL. A review of variant hemoglobins interfering with hemoglobin A1c measurement. J Diabetes Sci Technol 2009; 3: 446-451
    CrossrefPubMedGoogle Scholar
  • 10 Zhu Y, Williams LM. Falsely elevated hemoglobin A1c due to S-beta+-thalassemia interference in Bio-Rad Variant II Turbo HbA1c assay. Clin Chim Acta 2009; 409: 18-20
    CrossrefPubMedGoogle Scholar
  • 11 Nathan DM, Kuenen J, Borg R. et al. Translating the A1C assay into estimated average glucose values. Diabetes Care 2008; 31: 1473-1478
    CrossrefPubMedGoogle Scholar
  • 12 Serdar MA, Koldaş M, Serteser M. et al. A simple and easy process for the determination of estimated plasma glucose level in patients presenting to hospital:an example of multicentric data mining. J Lab Autom 2016; 21: 794-798
    CrossrefPubMedGoogle Scholar
  • 13 Munshi MN, Segal AR, Slyne C. et al. Shortfalls of the use of HbA1c-defined eAG in older aduls with diabetes. Diabetes Res Clin Pract 2015; 110: 60-65
    CrossrefPubMedGoogle Scholar
  • 14 Loh TP, Sethi SK, Wong MS. et al. Relationship between measured average glucose by continuous glucose monitor and HbA1c measured by three different routine laboratory methods. Clin Biochem 2015; 48: 514-518
    CrossrefPubMedGoogle Scholar
  • 15 Kim HY, Lee SY, Suh S. et al. The relationship between estimated average glucose and fasting plasma glucose. Clin Chem Lab Med 2013; 51: 2195-2200
    PubMedGoogle Scholar
  • 16 Little RR, Vesper H, Rohlfing CL. et al. Validation by a mass spectrometric reference method of use of boronate affinity chromatography to measure glycohemo-globin in the presence of hemoglobin S and C traits. Clin Chem 2005; 51: 264-265
    CrossrefPubMedGoogle Scholar
  • 17 Lin CN, Emery TJ, Little RR. et al. Effects of hemoglobin D,E and S traits on measurements of HbA1c by six methods. Clin Chim Acta 2012; 413: 819-821
    CrossrefPubMedGoogle Scholar
  • 18 Little RR, Rohlfing CL, Hanson S. et al. Effects of hemoglobin (Hb) E and HbD traits on measurements of glycated Hb (HbA1c) by 23 methods. Clin Chem 2008; 54: 1277-1282
    CrossrefPubMedGoogle Scholar
  • 19 Sthaneshwar P, Shanmugam H, Swan VG. et al. Effect of HbE heterozygosity on the measurement of HbA1c. Pathology 2013; 45: 417-419
    CrossrefPubMedGoogle Scholar
  • 20 Ji L, Yu J, Zhou Y. et al. Erroneous HbA1c measurements in the presence of β-thalassemia and common Chinese hemoglobin variants. Clin Chem Lab Med 2015; 53: 1451-1458
    PubMedGoogle Scholar
  • 21 Jeanne M. Rhea, Ross Molinaro Pathology Consultation on HbA1c methods and Inerferences. Am J Clin Pathol 2014; 141: 5-16
    CrossrefPubMedGoogle Scholar
  • 22 Weykamp C. HbA1c: A review of analytical and clinical aspect. Ann Lab Med 2013; 33: 393-400
    CrossrefPubMedGoogle Scholar
  • 23 Little RR, Rohlfing CL, Sacks DB. National Glycohemoglobin Standardization Program (NGSP) Steering Committee. Status of hemoglobin A1c measurement and goals for improvement: From chaos to order for improving diabetes care. Clin Chem 2011; 57: 205-214
    CrossrefPubMedGoogle Scholar
  • 24 International Federation of Clinical Chemistry and Laboratory Medicine, IFCC Scientific Division. Mosca A, Goodall I, Hoshino T. et al. Global standardization of glycated hemoglobin measurement: the position of the IFCC Working Group. Clin Chem Lab Med 2007; 45: 1077-1080
    PubMedGoogle Scholar
  • 25 Song Z, Xie B, Ma H. et al. Modified HPLC-ESI-MS method for glycated hemoglobin quantification based on the IFCC reference measurement procedure and its application for quantitative analyses in clinical laboraries of China. J Clin Lab Anal 2016; 30: 457-463
    CrossrefPubMedGoogle Scholar
  • 26 Roberts NB, Amara AB, Morris M. et al. Long-term evaluation of electrospray ionization mass spectrometric analysis of glycated hemoglobin. Clin Chem 2001; 47: 316-321
    CrossrefPubMedGoogle Scholar
  • 27 Davison AS, Green BN, Roberts NB. Fetal hemoglobin: Assessment of glycation and acetylation status by electrospray ionization mass spectrometry. Clin Chem Lab Med 2008; 46: 1230-1238
    PubMedGoogle Scholar
  • 28 Davison AS, Green BN, Roberts NB. Diabetes in pregnancy: Effect on glycation and acetylation of the different chains of fetal and maternal hemoglobin. Clin Biochem 2011; 44: 198-202
    CrossrefPubMedGoogle Scholar
  • 29 Sawaragi W, Shibuya H, Yasuda K. et al. Evaluation of HbA1c using different methods in haemoglobin variant, Hb J-Bankok. Rinsho Byori 2009; 57: 431-435
    PubMedGoogle Scholar
  • 30 Wang Y, Zhang K, Xu Z. et al. The presence of Hb J-Bankok caused spuriously low glycated hemoglobin value on the Tosoh G7. Scand J Clin Lab Invest 2014; 74: 725-727
    CrossrefPubMedGoogle Scholar