Assesment of Analytical Performance of HbA1C Test by Six Sigma Methodology

Year 2020, Volume: 4 Issue: 2, 104 - 107, 01.06.2020

Dilek Iren Emekli Kenan Guclu Rukiye Nar Esin Avc

https://doi.org/10.30621/jbachs.2020.869

Abstract

Background and Objective: The HbA1 c test is a biomarker used to evaluate the long-term outcomes of diabetes, and therefore its role in diabetes management is important Analytical reliability of clinical laboratories may be obtained by Internal Quality Control IQC , External Quality Control EQC etc. by analyzing the data with statistical methods. In six sigma methodology, which is one of these methods, the analytical performance can be evaluated with a single number named “process sigma value”. This study aimed to compare the six sigma levels in line with the results of IQC and EQC of HbA1 c tests which is one of the most commonly used tests in our laboratory. Material and Methods: IQC and EQC data between May 2015-August 2015 were collected. Monthly process sigma levels were calculated by using formula “ TEa% - Bias% /CV%. For Bias; values that the firm provided from IQC results and the standard deviation index SDI values in EQC reports were used. 6% were basis for the allowed total error values NGSP . Results: Process sigma level were determined according to IQC1, IQC2 and EQC results by month as May 3.4–8.4–9.6 , June 3.9–5.2–4.5 , July 5.9–8.4–4.7 , August 8.7–8.4–8.2 , respectively in 2015. Conclusions: In our study it was observed that HbA1C test is in conformity with the process sigma levels according to IQC and EQC data. HbA1 c test was found to be compatible with internal quality control and external quality control results in accordance with process sigma levels and it was also evaluated as favorable considering our laboratory performance.

Keywords

Quality assessment, six sigma, analytical reliability

References

• 1. Radin MS. Pitfalls in Hemoglobin A1c Measurement: When Results may be Misleading. J Gen Intern Med 2014;29:388–394. [CrossRef]
• 2. Tekce BK, Tekce H, Aktaş G, Tosun M. Comparing the HbA1c Assay Results of Architect C 8000 and MQ-2000PT. Jarem 2015;5:52–55. [CrossRef]
• 3. Nathan DM, Turgeon H, Regan S. Relationship between glycated hemoglobin levels and mean glucose levels over time. Diabetologia 2007;50:2239–2244. [CrossRef]
• 4. Dutta A, Dudhe AP, Deb S, Dasgupta S, Sarkar A. A study on assessment of HbA1c level as a diagnostic criterion of type 2 diabetes mellitus. Asian J Med Sci 2016;7:49–52. [CrossRef]
• 5. Sacks DB. Measurement of hemoglobin A1c: a new twist on the path to harmony. Diabetes Care 2012;35:2674–2680. [CrossRef]
• 6. Goodall I, Colman PG, Schneider HG, McLean M, Barker G. Desirable performance standards for HbA1c analysis - precision, accuracy and standardisation: consensus statement of the Australasian Association of Clinical Biochemists (AACB), the Australian Diabetes Society (ADS), the Royal 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. [CrossRef]
• 7. 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. [CrossRef]
• 8. 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. [CrossRef]
• 9. Aslan D, Demir S. Laboratuvar Tıbbında Altı Sigma Kalite Yönetimi. Turk J Biochem 2005;30:272–278. [CrossRef]
• 10. Aslan D, Sert S, Aybek H, Yılmaztürk G. Klinik laboratuvarlarda toplam laboratuvar performansının değerlendirilmesi: Normalize OPSpec Grafikleri, Altı Sigma ve Hasta Test Sonuçları. Turk J Biochem 2005;30;296–305. https://docplayer.biz.tr/8108357- Klinik-laboratuvarlarda-toplam-laboratuvar-performansinindegerlendirilmesi-normalize-opspec-grafikleri-alti-sigma-ve-hastatest-sonuclari.html
• 11. Hens K, Berth M, Armbruster D, Westgard S. Sigma metrics used to assess analytical quality of clinical chemistry assays: importance of the allowable total error (TEa) target. Clin Chem Lab Med 2014;52:973– 980. [CrossRef]
• 12. Berte ML. Laboratory Quality Management: A Road Map. Clin Lab Med 2007;27:771–790. [CrossRef]
• 13. Coskun A, editor. Quality Management and Six Sigma. Rijeka, Croatia; 2010. www.sciyo.com [CrossRef]
• 14. Lachin JM, Genuth S, Nathan DM, Zinman B, Rutledge BN; DCCT/ EDIC Research Group. Effect of glycemic exposure on the risk of microvascular complications in thediabetes control and complications trial revisited. Diabetes 2008;57:995–1001. [CrossRef]
• 15. Little RR, Rothlfing CL, Wiedmeyer H-M, Myers GL, Sacks DB, Goldstein DE. The National Gtycohemoglobin Standardization Program (NGSP): A five-year progress report. Clin Chem 2001;47:1985–1992.
• 16. Little RR. Glycated Hemoglobin Standardization National Glycohemoglobin Standardization Program (NGSP) Perspective, Review. Clin Chem Lab Med 2003;41:1191–1198.
• 17. 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. [CrossRef]
• 18. Huysal K, Budak YU. Application of sigma metrics for the assessment of quality assurance using the MQ-2000 PT HbA1c analyzer. Biochemia Medica 2015;25:416–420. [CrossRef]
• 19. Asberg A, Odsaeter IH, Carlsen SM, Mikkelsen G. Using the likelihood ratio to evaluate allowable total error: an example with glycated hemoglobin (HbA1c). Clin Chem Lab Med 2015;53:1459–1464. [CrossRef]
• 20. Weykamp C, John G, Gillery P, et al. Investigation of two models to set and evaluate quality targets for HbA1c: biological variation and Sigma-metrics. Clin Chem 2015;61:752–759. [CrossRef]
• 21. Maine G, Armbruster D, Litten J, Pickering S, Jortani S, Westgard S. Assessing Analytical Quality of Hba1c Assays Using Sigma Metrics, Poster Abstract T418. Paris: EuroMedLab; 2015. p.S1011. [CrossRef]
• 22. Lenters-Westra E, English E. Understanding the use of sigma metrics in hemoglobin A1c analysis. Clin Lab Med 2017;37:57–71. [CrossRef]
• 23. Bozkaya G, Uzuncan N, Bilgili S, Demirezen O. Evaluation of Analytical Performance of Variant II Turbo HbA1c Analyzer According to Sigma Metrics. J Med Biochem 2019;38:33–37. [CrossRef]
• 24. Wang X, Wen D, Wang W, Suo M, Hu T. Application of biological variation and six sigma models to evaluate analytical quality of six HbA1c analyzers and design quality control strategy. Artif Cells Nanomed Biotechnol 2019;47:3598–3602. [CrossRef]