Comparison of HPLC with Tinia for hba1c measurement in diabetic and non-diabetic patient; a study from a tertiary care hospital of Baluchistan
DOI:
https://doi.org/10.59736/IJP.22.03.890Keywords:
HPLC, Tinia, HbA1c, ComparisonAbstract
Background: Diabetes mellitus, a disease with serious implications on human health ,is on continuous rise. It is the need of hour to find and establish the markers to measure its long term effects. Diabetes Control and Complication Trial has confirmed role of HbA1c in effective blood glucose level monitoring .New methods are being developed for measurement of HbA1c .Before using these methods, it is essential to analyze these methods for reliability .Therefore in our study we will compare and evaluate correlation and agreement between Turbidimetric Inhibition Immunoassay TINIA and High Performance Liquid Chromatography HPLC for HbA1c measurement.
Methods: Three hundred and ninety-four samples were analyzed simultaneously on Roche Cobas 501 and D-10 HbA1c analyzer by Bio-Rad for HbA1c level estimation. The results were entered into SPSS version 26 for method validation. This is an observational study conducted at Department of Pathology CMH Quetta from January 2022 to August 2023.
Results: Inter and intra run coefficient of variation (CV) was within the allowable limit of 2 %. Mean difference between results of Turbidimetric Inhibition Immunoassay TINIA and High-Performance Liquid Chromatography HPLC was very low with HPLC results slightly on higher side. For low control TINIA had between run CV of 0.3% (Low control) 0.8 % (High control) and within run CV of 0.3% (Low control), 0.6% (High control); while HPLC had between run CV of 0.6%(Low control) 1.8% (High control), and within run CV of 0.3% (Low control), and 0.7%. Linear regression analysis displayed high concordance and agreement between the results of both methods.
Conclusion: Both methods have comparable results in HbA1c estimation.
References
Rama Chandran S, A. Vigersky R, Thomas A, Lim LL, Ratnasingam J, Tan A, SL Gardner D. Role of composite glycemic indices: A Comparison of the Comprehensive Glucose Pentagon Across Diabetes Types and HbA1c Levels. Diabetes Technol Ther.2020 Feb 1; 22(2):103-11.
Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas. Diabetes Res Clin Pract. 2019 Nov 1; 157:107843. doi: 10.1016/j.diabres.2019.107843
Klonoff DC, Aron D, Cohen RM, Home P, John WG, Little RR, et al.The need for accuracy in hemoglobin A1C proficiency testing: why the proposed CLIA rule of 2019 is a step backward. J Diabetes Sci Technol. 2019 May; 13(3):424-7.
Ceriello A, Monnier L, Owens D. Glycaemic variability in diabetes: clinical and therapeutic implications. Lancet Diabetes endocrinol. 2019 Mar 1; 7(3):doi: 10.1016/S2213-8587(18)30136-0. Epub 2018 Aug 13. PMID: 30115599.
Greiner GG, Emmert-Fees KM, Becker J, Rathmann W, Thorand B, Peters A, et al. Toward targeted prevention: risk factors for prediabetes defined by impaired fasting glucose, impaired glucose tolerance and increased HbA1c in the population-based KORA study from Germany. Acta diabetol. 2020 Dec; 57(12):1481-91. doi: 10.1007/s00592-020-01573-x.
Jang JY, Moon S, Cho S, Cho KH, Oh CM. Visit-to-visit HbA1c and glucose variability and the risks of macrovascular and microvascular events in the general population. Sci Rep. 2019 Feb 4;9(1):1-8. doi: 10.1038/s41598-018-37834-7.
Lee S, Zhou J, Wong WT, Liu T, Wu WK, Wong IC, Zhang Q, Tse G. Glycemic and lipid variability for predicting complications and mortality in diabetes mellitus using machine learning. BMC Endocr Disord. 2021 May 4; 21(1):1-5. Doi: 10.1186/s12902-021-00751-4.
Sriwimol W, Choosongsang P, Choosongsang P, Treerut P, Muenniam B, Makkong P, et al. Strong correlation and high comparability of capillary electrophoresis and three different methods for HbA1c measurement in a population without hemoglobinopathy. Scand J Clin Lab Invest. 2020 Feb-Apr; 80(2):139-150. Doi: 10.1080/00365513.2019.1703213.
Goya K, Tanaka S, Makio T, Kanno M, Tabuchi Y, Fukuzawa K,et al. HbA1c levels Measured by Enzymatic Assay and Immunoassay during Off-Site Health Checkups Are Both Lower than Those Measured by On-Site HPLC Assay. Kobe J Med Sci. 2021 Mar 25; 66(5):E170-E174.
Okeyo HM, Biddle M, Williams LB. Impact of Diabetes Self-Management Education on A1C Levels among Black/African Americans: A Systematic Review. Sci Diabetes Self Manag Care. 2024 Feb; 50(1):87-95. Doi: 10.1177/26350106231213400.
Gilani M, Aamir M, Akram A, Haroon ZH, Ijaz A, Khadim MT. Comparison of turbidimetric inhibition immunoassay, high-performance liquid chromatography, and capillary electrophoresis methods for glycated hemoglobin determination. Lab Med. 2020 Nov 2;51(6):579-84. Doi: 10.
Altawallbeh G, Makky VF, Saenger AK, Peters JM, Killeen AA. Evaluation of an ion-exchange HPLC device for HbA1c measurement. J Appl Lab Med. 2020 Jul 1; 5(4):695-703. Doi: 10.1093/jalm/jfaa042.
Juang YJ, Wu HM, Cheng YW, Eng HL, Lin TM. Influence of RBC Indices on HbA1c Measurement by Capillary Electrophoresis and HPLC Methods. Clin Lab. 2022 Aug 1; 68(8). Doi: 10.7754/Clin.Lab.2021.211053.
Sriwimol W, Choosongsang P, Choosongsang P, Treerut P, Muenniam B, Makkong P,et al. Strong correlation and high comparability of capillary electrophoresis and three different methods for HbA1c measurement in a population without hemoglobinopathy. Scand J Clin Lab Invest. 2020 Feb-Apr; 80(2):139-50. Doi: 10.1080/00365513.2019.1703213.
Fırat Oğuz E, Eren F, Neşelioğlu S, Akbıyık F, Erel Ö. Comparison of three different HbA1c measurement methods–the Atellica® CH930, Capillary 3 Tera, and BioRad Variant Turbo II. Scand J Clin Lab Invest. 2022 May; 82(3):218-25. doi: 10.1080/00365513.2022.2051070.
Saeed S, Khattak M, Syed S, Khan JA, Amir M, Khattak A. Analysis of HBA1C by TINIA and HPLC in diabetic patients attending a tertiary care Hospital. Pakistan Journal of Pathology. 2020; 31(2):42-5.
Cihan M, Üner A, Kılınçkaya MF, Noyan T. Comparison of high performance liquid chromatography and turbidimetric inhibition immunoassay methods for measurement of hemoglobin A1c. Journal of Health Sciences and Medicine. 2022 Sep 9; 5(5):1281-5.1
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