Evaluation of serum electrolytes measurement through the 6-year trueness verification program in China
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Ying Yan
Abstract
Objectives
The National Center for Clinical Laboratories (NCCL) in China initiated a serum electrolyte trueness verification (ETV) program in 2014 for measurement standardization.
Methods
Every year, two levels of fresh frozen commutable serum samples determined by inductively coupled plasma mass spectrometry (ICP-MS) reference methods were transported to participating clinical laboratories for the measurement of sodium, potassium, calcium and magnesium. Both samples were measured 15 times in 3 days, and the mean values and coefficient variations (CVs) were calculated from the results. The tolerance limits of trueness (bias), precision (CV) and accuracy (TE) based on the biological variation database were used as the evaluation criteria. The overall trend of the ETV program over 6 years was surveyed by calculating the pass rates of the participating laboratories. The mean bias, inter-laboratory CV, and TE of all laboratory results were analysed. Furthermore, homogeneous and heterogeneous systems were compared, and the bias and CV results of mainstream analysis systems were analysed.
Results
Pass rates of the three quality specifications increased, and the overall mean bias and inter-laboratory CVs decreased. The homogeneous system was superior to the heterogeneous system for calcium and magnesium measurements. For sodium, potassium, calcium and magnesium, the minimum bias corresponded to Hitachi, Siemens, Beckman AU and Roche, respectively. For inter-laboratory robust CVs, no obvious differences were observed between each peer group.
Conclusions
The commutable ETV materials assigned via reference methods can evaluate the accuracy and reproducibility of an individual laboratory and the calibration traceability and uniformity between laboratories for measurements.
Funding source: National Key Technology R&D Program of China
Award Identifier / Grant number: 2011AA02A102
Research funding: This work was supported by the National Key Technology R&D Program of China (Grant 2011AA02A102).
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: Authors state no conflict of interest.
Ethical approval: Residual serum samples were collected at the clinical laboratory of Beijing Hospital with approval from the Ethics Committee of Beijing Hospital.
References
1. Burtis, CA, Ashwood, ER, Bruns, DE, editors. Fundamentals of clinical chemistry, 6th ed. St. Louis, MO: Saunders; 2007:432 p.Search in Google Scholar
2. Scott, MG, LeGrys, VA. Electrolytes and blood gases. In: Burtis, CA, Ashwood, ER, Bruns, DE, editors. Tietz fundamentals of clinical chemistry, 6th ed. Missouri: Saunders Press; 2008:431–5 pp.10.1016/B978-1-4160-6164-9.00028-7Search in Google Scholar
3. Brady, H, Ryan, M, Horgan, J. Magnesium: the forgotten cation. Ir Med J 1987;80:250–3. 3312087.Search in Google Scholar
4. Gowenlock, AH, McMurray, JR, McLauchlan, DH, editors. Varley’s practical clinical biochemistry, 6th ed. London: Heinemann Medical Books; 1988.10.1016/0009-8981(88)90045-9Search in Google Scholar
5. Belk, WP, Sunderman, FW. A survey of the accuracy of chemical analyses in clinical laboratories. Am J Clin Pathol 1947;17:853–61. https://doi.org/10.1093/ajcp/17.11.853.Search in Google Scholar
6. Wootton, ID, King, EJ. Normal values for blood constituents; interhospital differences. Lancet 1953;1:470–1. https://doi.org/10.1016/s0140-6736(53)91643-2.Search in Google Scholar
7. Cobbaert, C, Weykamp, C, Franck, P, de Jonge, R, Kuypers, A, Steigstra, H, et al. Systematic monitoring of standardization and harmonization status with commutable EQA-samples – five year experience from The Netherlands. Clin Chim Acta 2012;414:234–40. https://doi.org/10.1016/j.cca.2012.09.027.Search in Google Scholar PubMed
8. Bais, R. What information should manufacturers provide on their procedures? Clin Chem 2006;52:1624–5. https://doi.org/10.1373/clinchem.2006.069773.Search in Google Scholar PubMed
9. Singh, RJ, Grebe, SK, Yue, B, Rockwood, AL, Cramer, JC, Gombos, Z, et al. Precisely wrong? Urinary fractionated metanephrines and peer-based laboratory proficiency testing. Clin Chem 2005;51:472–4. https://doi.org/10.1373/clinchem.2004.043802.Search in Google Scholar PubMed
10. Wang, Y, Wang, J, Zhao, H, Zhang, J, Zhang, T, Zeng, J, et al. Assessment of enzyme measurement procedures in China through a trueness verification program. Clin Chim Acta 2016;461:98–102. https://doi.org/10.1016/j.cca.2016.07.008.Search in Google Scholar PubMed
11. Vesper, HW, Thienpont, LM. Traceability in laboratory medicine. Clin Chem 2009;55:1067–75. https://doi.org/10.1373/clinchem.2008.107052.Search in Google Scholar PubMed
12. Panteghini, M. Traceability, reference systems and result comparability. Clin Biochem Rev 2007;28:97–104. 17909614.Search in Google Scholar
13. Dybkaer, R. Metrology in laboratory medicine –Reference measurement systems. Accred Qual Assur 2001;6:16–9. https://doi.org/10.1007/pl00010430.Search in Google Scholar
14. Thienpont, LM, Van Uytfanghe, K, De Leenheer, AP. Reference measurement systems in clinical chemistry. Clin Chim Acta 2002;323:73–87. https://doi.org/10.1016/s0009-8981(02)00188-2.Search in Google Scholar
15. International Organization for Standardization. International vocabulary of basic and general terms in metrology, 2nd ed. Geneva, Switzerland: ISO; 1993.Search in Google Scholar
16. Yan, Y, Zhang, C, Zhang, J, Zhang, T, Zhou, W, Zeng, J, et al. Measurement of serum sodium and magnesium by inductively coupled plasma mass spectrometry with aluminum as internal standard. Clin Lab 2016;62:719–25. https://doi.org/10.7754/clin.lab.2015.150140.Search in Google Scholar PubMed
17. Yan, Y, Han, B, Zeng, J, Zhou, W, Zhang, T, Zhang, J, et al. A candidate reference method for serum potassium measurements by inductively coupled plasma mass spectrometry. Clin Chem Lab Med 2017;55:1517–22. https://doi.org/10.1515/cclm-2016-0803.Search in Google Scholar PubMed
18. Yan, Y, Ge, M, Ma, R, Zhao, H, Wang, D, Hu, C, et al. A candidate reference method for serum calcium measurement by inductively coupled plasma mass spectrometry. Clin Chim Acta 2016;461:141–5. https://doi.org/10.1016/j.cca.2016.07.004.Search in Google Scholar PubMed
19. Clinical and Laboratory Standards Institute. Evaluation of commutability of processed samples. approved guideline, 3rd ed.; 2014. ISBN 1-56238-971-8; CLSI document EP 14-A3.Search in Google Scholar
20. Yan, Y, Han, B, Zhao, H, Ma, R, Wang, J, Wang, D, et al. Commutability of external quality assessment materials for serum sodium and potassium measurements. Clin Chem Lab Med 2019;57:465–75. https://doi.org/10.1515/cclm-2018-0385.Search in Google Scholar PubMed
21. Yan, Y, Pu, Y, Long, Q, Zhang, J, Zhang, T, Zhou, W, et al. Commutability of external quality assessment materials for serum magnesium and calcium measurements. Scand J Clin Lab Invest 2019;79:404–11. https://doi.org/10.1080/00365513.2019.1636404.Search in Google Scholar PubMed
22. ISO/IEC Guide 98-3:2008. Uncertainty of measurement – part 3: guide to the expression of uncertainty in measurement (GUM:1995). Geneva: ISO; 2008.Search in Google Scholar
23. Ellison, SL, Rosslein, M, Williams, A, editors. EURACHEM/CITAC guide CG 4: quantifying uncertainty in analytical measurement, 2nd ed. Czech Republic: EURACHEM; 2000.Search in Google Scholar
24. EFLM biological variation database. [Internet]; 2019. Available from: https://biologicalvariation.eu/.Search in Google Scholar
25. Desirable biological variation database specifications. [Internet]; 2014. Available from: https://www.westgard.com/biodatabase1.htm.Search in Google Scholar
26. ISO 13528:2015 (E). Statistical methods for use in proficiency testing by interlaboratory comparison.Search in Google Scholar
27. Department of Health and Human Services, Center for Medicare and Medicaid Services. CLIA’88 Final rule. Federal register, 1992.Search in Google Scholar
28. Analytical quality specifiation for routine analytes in clinical biochemistry, WS/T 403–2012.Search in Google Scholar
29. Goossens, K, Van Uytfanghe, K, Thienpont, LM. Trueness and comparability assessment of widely used assays for 5 common enzymes and 3 electrolytes. Clin Chim Acta 2015;442:44–5. https://doi.org/10.1016/j.cca.2015.01.009.Search in Google Scholar PubMed
30. Clinical and Laboratory Standards Institute. User verification of precision and estimation of bias; approved guideline, 3rd ed.; ISBN 1-56238-965-3; CLSI document EP 15-A3, 2014.Search in Google Scholar
© 2020 Walter de Gruyter GmbH, Berlin/Boston
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