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Original Articles

Application of biological variation and sigma metrics to evaluate the performance of HbA1c in external quality assessment

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Pages 398-403 | Received 16 Feb 2022, Accepted 07 Jul 2022, Published online: 23 Jul 2022

References

  • GBD 2016 Disease and Injury Incidence and Prevalence Collaborators Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the global burden of disease study 2016. Lancet. 2017;390:1211–1259.
  • International Diabetes Federation. International Diabetes Federation Diabetes atlas, nine edition. https://diabetesatlas.org/en/resources. (Update on 2021. 9-3).
  • American Diabetes Association Diagnosis and classification of diabetes mellitus. Diabetes Care. 2013;36(Suppl 1):S67–S74.
  • World Health Organization. Use of glycated haemoglobin (HbA1c) in the diagnosis of diabetes mellitus: Abbreviated report of a WHO consultation. Geneva: WHO, 2011.
  • Miller WG. The role of proficiency testing in achieving standardization and harmonization between laboratories. Clin Biochem. 2009;42(4-5):232–235.
  • Tetrault G. Evaluating laboratory performance with the six sigma scale. Arch Pathol Lab Med. 2000;124(12):1748–1749.
  • Sandberg S, Fraser CG, Horvath AR, et al. Defining analytical performance specifications: Consensus statement from the 1st strategic conference of the European federation of clinical chemistry and laboratory medicine. Clin Chem Lab Med. 2015;53(6):833–835.
  • Weykamp C, John G, Gillery P, IFCC Task Force on Implementation of HbA1c Standardization, 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.
  • EFLM. List of Matrices with Biological Variation Datasets. https://biologicalvariation.eu/bv_specifications/measurand. (Update on 2021. 9-3).
  • Westgard JO, Westgard SA. The quality of laboratory testing today: an assessment of sigma metrics for analytic quality using performance data from proficiency testing surveys and the CLIA criteria for acceptable performance. Am J Clin Pathol. 2006;125(3):343–354.
  • College of American Pathologists. Proficiency Testing Manual. https://documents.cap.org/documents/2019-ProficiencyTesting-Manual_FINAL.pdf.
  • International Organization for Standardization. Statistical methods for use in proficiency testing by interlaboratory comparison. ISO 13528. Geneva: ISO, 2015.
  • Heylen O, Van Neyghem S, Exterbille S, et al. Evaluation of the sebia CAPILLARYS 2 flex piercing for the measurement of HbA(1c) on venous and capillary blood samples. Am J Clin Pathol. 2014;141(6):867–877.
  • Bruns DE, Boyd JC. Few point-of-care hemoglobin A1c assay methods meet clinical needs. Clin Chem. 2010;56(1):4–6.
  • 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.
  • Klingenberg O, Furuset T, Hestbråten CR, et al. HbA1c analysis by capillary electrophoresis - comparison with chromatography and an immunological method. Scand J Clin Lab Invest. 2017;77(6):458–464.
  • Wu X, Chao Y, Wan Z, et al. A comparative evaluation of the analytical performances of capillarys 2 flex piercing, tosoh HLC-723 G8, premier Hb9210, and roche cobas c501 tina-quant gen 2 analyzers for HbA1c determination. Biochem Med (Zagreb). 2016;26(3):353–364.
  • College of American Pathologists Survey Data. CAP GH-5a 2021 Summary. http://www.ngsp.org/CAPdata.asp (Update on 2021-9-3).
  • Fasano T, Bedini JL, Fle PA, et al. Multi-site performance evaluation and sigma metrics of 20 assays on the atellica chemistry and immunoassay analyzers. Clin Chem Lab Med. 2019;58(1):59–68.
  • Taher J, Cosme J, Renley BA, et al. A novel sigma metric encompasses global multi-site performance of 18 assays on the abbott alinity system. Clin Biochem. 2019;63:106–112.
  • Zhou B, Wu Y, He H, et al. Practical application of six sigma management in analytical biochemistry processes in clinical settings. J Clin Lab Anal. 2020;34(1):e23126.