768
Views
0
CrossRef citations to date
0
Altmetric
Note

Analytical evaluation and quality assessment of the ARKRAY ADAMS A1c Lite HA-8380V for HbA1c

ORCID Icon
Pages 358-365 | Received 10 Feb 2023, Accepted 11 Jun 2023, Published online: 23 Jun 2023

References

  • The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Eng J Med. 1993;329:977–986.
  • UK Prospective Diabetes Study (UKPDS) Group. Intensive blood glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33.) Lancet. 1998;352:837–853.
  • Consensus statement on the worldwide standardization of the haemoglobin A1C measurement: the American Diabetes Association. European association for the study of diabetes, international federation of clinical chemistry and laboratory medicine, and the international diabetes federation. Diabetes Care. 2007;30:2399–2400.
  • World Health Organization. International diabetes federation. Definition and diagnosis of diabetes mellitus and intermediate hyperglycaemia: report of a WHO/IDF consultation. Geneva: WHO Press; 2006.
  • American Diabetes Association. Standards of medical care in diabetes-2010. Diabetes Care. 2010;33:S11–S61.
  • World Health Organization. Diabetes Fact Sheet. 30 October 2018. https://www.who.int/news-room/fact-sheets/detail/diabetes. Accessed 3rd December 2021.
  • CLSI. User verification of precision and estimation of bias; approved guideline. 3rd Ed. CLSI document EP5-A3. Wayne (PA): Clinical and Laboratory Standards Institute; 2014.
  • Jeppsson JO, Kobold U, Barr J. alApproved IFCC reference method for the measurement of HbA1c in human blood. Clin Chem Lab Med. 2002;40:78–89.
  • CLSI. Preliminary evaluation of quantitative clinical laboratory measurement procedures; approved guideline. 3rd Ed. CLSI document EP10-A3-AMD. Wayne (PA): Clinical and Laboratory Standards Institute; 2014.
  • CLSI. Evaluation of the linearity of quantitative measurement procedure: a statistical approach; approved guideline. CLSI Document EP06-A. Wayne (PA): Clinical and Laboratory Standards Institute; 2003.
  • Passing H, Bablok W. A new biometrical procedure for testing the equality of measurements from two different analytical methods. J Clin Chem Clin Biochem. 1983; 21(11): 709–720. doi: 10.1515/cclm.1983.21.11.709.
  • Bland JM, Altman DG. Statistical method for assessing agreement between two methods of clinical measurements. Lancet. 1986;327(8476):307–310. doi: 10.1016/S0140-6736(86)90837-8.
  • 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.
  • Braga F, Dolci A, Montagnana M, et al. Revaluation of biological variability of glycated hemoglobin using an accurately designed protocol and an assay traceable to the IFCC reference system. Clin Chim Acta. 2011;412(15–16):1412–1416. doi: 10.1016/j.cca.2011.04.014.
  • Goodall I, Colman PG, Schneider HG, et al. Desirable performance standards for HbA1c analysis - Precision, accuracy, and standardisation: consensus statement of the Australasian association of 18 clinical biochemists (AACB), the Australian diabetes society (ADS), the royal 19 college of pathologists of Australasia (RCPA), endocrine society of Australia (ESA), and the Australian diabetes educators association (ADEA). Clin Chem Lab Med. 2007;45:1083–1097.
  • Urrechaga E. Evaluation of ADAMS™ A1c HA-8180V HPLC analyzer for HbA1c determination. J Life Sci USA. 2012;6:456–460.
  • Urrechaga E. Analytical evaluation of the ADAMS ™ A1c HA-8180 thalassemia mode analyser for the measurement of HbA1c. J Clin Lab Anal. 2018;32(1):e22155. doi: 10.1002/jcla.22155.
  • Weykamp C, Lenters-Westra E, van der Vuurst H, et al. Evaluation of the menarini/ARKRAY ADAMS A1c HA-8180V analyser for HbA1c. Clin Chem Lab Med. 2011;49(4):647–651. doi: 10.1515/CCLM.2011.096.
  • van der Hagen EAE, Leppink S, Bokker K, et al. Evaluation of the ARKRAY HA-8190V instrument for HbA1c. Clin Chem Lab Med. 2021;59(5):965–970. doi: 10.1515/cclm-2020-1300.
  • Urrechaga E. Analytical evaluation and quality assessment of the ARKRAY ADAMS A1c HA-8190V for Hb A1c. Scand J Clin Lab Invest. 2023;83(2):136–142. doi: 10.1080/00365513.2023.2167231.
  • Weykamp C, John G, Gillery P, et al. Investigation of 2 models to set and evaluate quality targets for Hb A1c: biological variation and sigma-metrics. Clin Chem. 2015;61(5):752–759. doi: 10.1373/clinchem.2014.235333.
  • Gallagher EJ, Le Roith D, Bloomgarden Z. Review of hemoglobin A(1c) in the management of diabetes. J Diabetes. 2009;1(1):9–17. doi: 10.1111/j.1753-0407.2009.00009.x.
  • Heinemann L, Freckmann G. Quality of HbA1c measurement in the practice. The german perspective. J Diabetes Sci Technol. 2015;9(3):687–695. doi: 10.1177/1932296815572254.
  • Rodriguez-Segade S, Rodriguez Garcia J, García-López JM, et al. Impact of mean cell hemoglobin on Hb A1c-defined glycemia status. Clin Chem. 2016;62(12):1570–1578. doi: 10.1373/clinchem.2016.257659.
  • Urrechaga E. Influence of iron deficiency on Hb A1c levels in type 2 diabetic patients. Diabetes Metab Syndr. 2018;12(6):1051–1055. doi: 10.1016/j.dsx.2018.06.024.
  • Urrechaga E. Incidental detection of Hb disorders during HbA1c analysis. J Diabetes Sci Technol. 2015;9(3):713. doi: 10.1177/1932296815574727.
  • Rhea JM. Impact of hemoglobin variants on HbA1c ­interpretation: do we assume too much? Med Lab Obser. 2012;6:8–14.
  • Rohlfing C, Hanson S, Estey MP, et al. Evaluation of interference from hemoglobin C, D, E and S traits on measurements of hemoglobin A1c by fifteen methods. Clin Chim Acta. 2021;522:31–35. doi: 10.1016/j.cca.2021.07.027.
  • http://www.ngsp.org/factors.asp. Accessed 10th May 2022.
  • Little RR, Rohlfing CL, Tennill AL, et al. 35 Measurement of Hba1C in patients with chronic renal failure. Clin Chim Acta. 2013;418:73–76. doi: 10.1016/j.cca.2012.12.022.
  • Desmons A, Jaisson S, Leroy N, et al. Labile glycated haemoglobin and carbamylated haemoglobin are still critical points for HbA1c measurement. Biochem Med. 2017;27(2):378–386. doi: 10.11613/BM.2017.039.
  • Cercado AG, Álvarez Conde GB, Guadalupe Vargas ME, et al. Hemoglobin A1c, diabetes mellitus, diabetic nephropathy and chronic kidney disease. Rev Nefrol Dial Traspl. 2017;37(4):225–242.
  • Finamore F, Priego-Capote F, Nolli S, et al. Aspirin-mediated acetylation of haemoglobin increases in presence of high ­glucose concentration and decreases protein glycation. EuPA Open Proteomics. 2015;8:116–127. doi: 10.1016/j.euprot.2015.04.003.
  • 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(2–3):198–202. doi: 10.1016/j.clinbiochem.2010.09.015.