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Research Articles

Evaluation of the Premier Hb9210 instrument for HbA1c determination

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Pages 569-575 | Received 17 Jun 2023, Accepted 22 Oct 2023, Published online: 01 Dec 2023

References

  • Glovaci D, Fan W, Wong ND. Epidemiology of diabetes mellitus and cardiovascular disease. Curr Cardiol Rep. 2019;21(4):21. doi: 10.1007/s11886-019-1107-y.
  • World Health Organization (WHO.): classification of diabetes mellitus. Geneva: World Health Organization; 2019.
  • Cho NH, Shaw JE, Karuranga S, et al. IDF diabetes atlas: global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018;138:271–281. doi: 10.1016/j.diabres.2018.02.023.
  • Strain WD, Paldánius PM. Diabetes, cardiovascular disease and the microcirculation. Cardiovasc Diabetol. 2018;17(1):57. doi: 10.1186/s12933-018-0703-2.
  • American Diabetes Association. Classification and diagnosis of diabetes: standards of medical care in diabetes. Diabetes Care. 2021;44(Suppl 1): S15–S33. doi: 10.2337/dc21-S002.
  • Sacks DB, Arnold M, Bakris GL, et al. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Diabetes Care. 2011;34(6):e61-99–e99. doi: 10.2337/dc11-9998.
  • World Health Organization (WHO). Use of glycated haemoglobin (HbA1c) in the diagnosis of diabetes mellitus: abbreviated report of a WHO consultation. Geneva. 2011.
  • Cavero-Redondo I, Peleteiro B, Álvarez-Bueno C, et al. Glycated haemoglobin A1c as a risk factor of cardiovascular outcomes and all-cause mortality in diabetic and non-diabetic populations: a systematic review and meta-analysis. BMJ Open. 2017;7(7):e015949. doi: 10.1136/bmjopen-2017-015949.
  • Weykamp C, Siebelder C. Evaluation of performance of laboratories and manufacturers within the framework of the IFCC model for quality targets of HbA1c. J Diabetes Sci Technol. 2018;12(4):747–752. doi: 10.1177/1932296817741320.
  • Little RR, Rohlfing C, Sacks DB. The national glycohemoglobin standardization program: over 20 years of improving hemoglobin A(1c) measurement. Clin Chem. 2019;65(7):839–848. doi: 10.1373/clinchem.2018.296962.
  • Hoelzel W, Weykamp C, Jeppsson JO, et al. IFCC reference system for measurement of hemoglobin A1c in human blood and the national standardization schemes in the United States, Japan, and Sweden: a method-comparison study. Clin Chem. 2004;50(1):166–174. doi: 10.1373/clinchem.2003.024802.
  • World medical association declaration of helsinki: ethical principles for medical research involving human subjects. Jama. 2013;310:2191–2194.
  • Guideline IH. Integrated addendum to ICH E6 (R1): guideline for good clinical practice E6 (R2). Current Step. 2015;2:1–60.
  • Wayne P. Clinical and laboratory standards institute (CLSI): user verification of precision and estimation of bias; Approved Guideline—Third Edition. CLSI document EP15-A3. USA; 2014.
  • Krouwer JS, Cembrowski GS, Tholen DW. Preliminary evaluation of quantitative clinical laboratory measurement procedures: Approved Guideline—Third Edition. Clinical and Laboratory Standards Institute (CLSI) document EP10-A3. USA; 2014.
  • Bilić-Zulle L. Comparison of methods: Passing and Bablok regression. Biochem Med (Zagreb). 2011;21(1):49–52. doi: 10.11613/bm.2011.010.
  • Little RR, La’ulu SL, Hanson SE, et al. 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.
  • Rhea JM, Molinaro R. Pathology consultation on HbA(1c) methods and interferences. Am J Clin Pathol. 2014;141(1):5–16. doi: 10.1309/AJCPQ23GTTMLAEVL.
  • del Rey TH, Conde-Sánchez M, Ropero-Gradilla P, et al. Hemoglobin seville [α2 β2 81(EF5) leu→phe] a silent phenotypic variant that interferes in hemoglobin A1c measurement by ion-exchange HPLC method. Clin Biochem. 2011;44(10-11):933–935. doi: 10.1016/j.clinbiochem.2011.04.007.
  • Dominguez-Pasual I. Glycosylated hemoglobin as a routine determination in the healthcare laboratory. Critical evaluation of the different techniques. Spain: Sevilla University; 2013.
  • Imrit C, Neergheen-Bhujun VS, Joonas N. Evaluation of the roche cobas b 101 glycosylated hemoglobin point-of-Care analyzer. Point of Care. 2017;16(3):135–137. doi: 10.1097/POC.0000000000000142.
  • Yadav N, Kumar Mandal A. Interference of hemoglobin variants in HbA(1c) quantification. Clin Chim Acta. 2023;539:55–65. doi: 10.1016/j.cca.2022.11.031.
  • Roche Diagnostics. HbA1c and interference due to hemoglobin disorders: Scientific discussion paper. https://diagnostics.roche.com/content/dam/diagnostics/Blueprint/en/resource-center/cps/Brochure%20HbA1c_scientific_discussion_paper_AND_variant_study.pdf.; 2013.
  • Jeppsson JO, Kobold U, Barr J, et al. Approved IFCC reference method for the measurement of HbA1c in human blood. Clin Chem Lab Med. 2002;40:78–89.
  • 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(2):205–214. doi: 10.1373/clinchem.2010.148841.
  • Arzuhal AE, Erden G, Ucar F, et al. Comparison of HbA1c analysers: agilent 1100 HPLC using kits produced by gordion diagnostic (Turkey) with premier Hb9210 using kits produced by Trinity biotech (USA) in different patient groups. Malays J Pathol. 2016;38:131–140.
  • Weykamp CW, Mosca A, Gillery P, et al. The analytical goals for hemoglobin A(1c) measurement in IFCC units and national glycohemoglobin standardization program units are different. Clin Chem. 2011;57(8):1204–1206. doi: 10.1373/clinchem.2011.162719.
  • 2. Classification and diagnosis of diabetes: standards of medical care in diabetes-2022. Diabetes Care. 2022;45:S17–S38.
  • John WG, Little R, Sacks DB, et al. Multicentre evaluation of the premier Hb9210 HbA1c analyser. Clin Chem Lab Med. 2015;53:319–327.
  • Rohlfing CL, Connolly SM, England JD, et al. The effect of elevated fetal hemoglobin on hemoglobin A1c results: five common hemoglobin A1c methods compared with the IFCC reference method. Am J Clin Pathol. 2008;129(5):811–814. doi: 10.1309/YFVTUD0GHJF7D16H.
  • Urrechaga E. Incidental detection of Hb disorders during HbA1c analysis. J Diabetes Sci Technol. 2015;9(3):713–713. doi: 10.1177/1932296815574727.
  • Rohlfing C, Hanson S, Weykamp C, et al. Effects of hemoglobin C, D, E and S traits on measurements of hemoglobin A1c by twelve methods. Clin Chim Acta. 2016;455:80–83. doi: 10.1016/j.cca.2016.01.031.
  • Sreedevi NN, Kumar GV, Chendar B, et al. Unexpected detection of abnormal hemoglobin variants during routine HbA1c analysis by HPLC technique: Challenges and opportunities in HbA1c testing. Avicenna J Med Biochem. 2021;9(1):15–21. doi: 10.34172/ajmb.2021.03.
  • Rohlfing C, Connolly S, Hanson S, et al. Validation of the use of Trinity biotech ultra2 as a comparative method for hemoglobin A1c measurements in the presence of HbE and HbD-Punjab traits. Clin Chem. 2017;63(2):608–610. doi: 10.1373/clinchem.2016.266221.
  • Goel S, Tripathi P, Sen A, et al. Hemoglobin E: a potential interferent in measurement of glycated hemoglobin. Int J Adv Med. 2020;7(9):1423. doi: 10.18203/2349-3933.ijam20203609.
  • Barrera-Reyes PK, Tejero ME. Genetic variation influencing hemoglobin levels and risk for anemia across populations. Ann N Y Acad Sci. 2019;1450(1):32–46. doi: 10.1111/nyas.14200.

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