Abstract
Objectives
Commutability of reference materials is essential for ensuring the traceability of patient measurement results and the technical basis for the use of reference materials. Commutability is only relevant for matrixed reference material; it is a prerequisite for the accuracy and authenticity of calibration methods. In this study, we evaluated the commutability of reference materials for homocysteine.
Methods
Five conventional measurement methods were applied to simultaneously measure 30 serum samples and seven homocysteine reference materials from the National Institute of Standards and Technology and the National Institute of Metrology. Liquid chromatography tandem-mass spectrometry was used as a reference method. Two methods were used to evaluate the commutability of the seven reference materials according to the Clinical and Laboratory Standards Institute EP30-A and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) commutability assessment document.
Results
Among 35 combinations of the five conventional methods and seven reference materials, after evaluation in accordance with the EP30-A, the seven reference materials passed the commutability assessment, and 34 combinations were commutable. According to the IFCC, the commutability evaluation of 28 combinations was conclusive (commutable or non-commutable), while results for the remaining seven combinations could not be determined.
Conclusions
The homocysteine reference materials showed good commutability. The sensitivity of the measurement procedure, measurement deviation and uncertainty, and differences in the “measurand” selected by different methods may affect the evaluation results. Additionally, different judgment standards for different methods may explain the observed variations in evaluation results.
Funding source: National Key Research and Development Program of China
Award Identifier / Grant number: 2017YFF0205401
Funding source: National Institute of Metrology Fundamental Research Project
Award Identifier / Grant number: AKYZD2115-1
-
Research funding: This work was financially supported by the National Key Research and Development Program of China (grant no. 2017YFF0205401) and by the National Institute of Metrology Fundamental Research Project (grant no. AKYZD2115-1).
-
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.
-
Informed consent: Not applicable.
-
Ethical approval: Not applicable.
References
1. Vesper, HW, Miller, WG, Myers, GL. Reference materials and commutability. Clin Biochem Rev 2007;28:139–47.Search in Google Scholar
2. Miller, WG, Myers, GL, Rej, R. Why commutability matters. Clin Chem 2006;52:553–4, https://doi.org/10.1373/clinchem.2005.063511.Search in Google Scholar PubMed
3. Miller, WG, Myers, GL. Commutability still matters. Clin Chem 2013;59:1291–3, https://doi.org/10.1373/clinchem.2013.208785.Search in Google Scholar PubMed
4. Braga, F, Panteghini, M. Commutability of reference and control materials: an essential factor for assuring the quality of measurements in laboratory medicine. Clin Chem Lab Med 2019;57:967–73, https://doi.org/10.1515/cclm-2019-0154.Search in Google Scholar PubMed
5. Clinical and Laboratory Standards Institute (CLSI). Characterization and qualification of commutable reference materials for laboratory medicine; Approved Guideline. CLSI document EP30-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2010.Search in Google Scholar
6. Clinical and Laboratory Standards Institute (CLSI). Evaluation of commutability of processed samples; Approved Guideline-Third Edition. CLSI document EP14-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2014.Search in Google Scholar
7. Miller, WG, Schimmel, H, Rej, R, Greenberg, N, Ceriotti, F, Burns, C, et al.. IFCC working group recommendations for assessing commutability part 1: general experimental design. Clin Chem 2018;64:447–54, https://doi.org/10.1373/clinchem.2017.277525.Search in Google Scholar PubMed PubMed Central
8. Nilsson, G, Budd, JR, Greenberg, N, Delatour, V, Rej, R, Panteghini, M, et al.. IFCC working group recommendations for assessing commutability part 2: using the difference in bias between a reference material and clinical samples. Clin Chem 2018;64:455–64, https://doi.org/10.1373/clinchem.2017.277541.Search in Google Scholar PubMed PubMed Central
9. Budd, JR, Weykamp, C, Rej, R, MacKenzie, F, Ceriotti, F, Greenberg, N, et al.. IFCC working group recommendations for assessing commutability part 3: using the calibration effectiveness of a reference material. Clin Chem 2018;64:465–74, https://doi.org/10.1373/clinchem.2017.277558.Search in Google Scholar PubMed
10. Delatour, V, Liu, Q, Vesper, HW, Commutability L-LWGo. Commutability assessment of external quality assessment materials with the difference in bias approach: are acceptance criteria based on medical requirements too strict? Clin Chem 2016;62:1670–1, https://doi.org/10.1373/clinchem.2016.261008.Search in Google Scholar PubMed PubMed Central
11. Carobene, A. Reliability of biological variation data available in an online database: need for improvement. Clin Chem Lab Med 2015;53:871–7, https://doi.org/10.1515/cclm-2014-1133.Search in Google Scholar PubMed
12. Deprez, L, Toussaint, B, Zegers, I, Schimmel, H, Grote-Koska, D, Klauke, R, et al.. Commutability assessment of candidate reference materials for pancreatic alpha-amylase. Clin Chem 2018;64:1193–202, https://doi.org/10.1373/clinchem.2018.289744.Search in Google Scholar PubMed
13. Chrysant, SG, Chrysant, GS. The current status of homocysteine as a risk factor for cardiovascular disease: a mini review. Expert Rev Cardiovasc Ther 2018;16:559–65, https://doi.org/10.1080/14779072.2018.1497974.Search in Google Scholar PubMed
14. Li, S, Sun, L, Qi, L, Jia, Y, Cui, Z, Wang, Z, et al.. Effect of high homocysteine level on the severity of coronary heart disease and prognosis after stent implantation. J Cardiovasc Pharmacol 2020;76:101–5, https://doi.org/10.1097/fjc.0000000000000829.Search in Google Scholar PubMed
15. Zhao, M, Wang, X, He, M, Qin, X, Tang, G, Huo, Y, et al.. Homocysteine and stroke risk: modifying effect of methylenetetrahydrofolate reductase C677T polymorphism and folic acid intervention. Stroke 2017;48:1183–90, https://doi.org/10.1161/strokeaha.116.015324.Search in Google Scholar PubMed
16. Feng, Y, Kang, K, Xue, Q, Chen, Y, Wang, W, Cao, J. Value of plasma homocysteine to predict stroke, cardiovascular diseases, and new-onset hypertension: a retrospective cohort study. Medicine (Baltim) 2020;99:e21541, https://doi.org/10.1097/md.0000000000021541.Search in Google Scholar PubMed PubMed Central
17. Windelberg, A, Arseth, O, Kvalheim, G, Ueland, PM. Automated assay for the determination of methylmalonic acid, total homocysteine, and related amino acids in human serum or plasma by means of methylchloroformate derivatization and gas chromatography-mass spectrometry. Clin Chem 2005;51:2103–9, https://doi.org/10.1373/clinchem.2005.053835.Search in Google Scholar PubMed
18. Nelson, BC, Pfeiffer, CM, Sniegoski, LT, Satterfield, MB. Development and evaluation of an isotope dilution LC/MS method for the determination of total homocysteine in human plasma. Anal Chem 2003;75:775–84, https://doi.org/10.1021/ac0204799.Search in Google Scholar PubMed
19. Hellmuth, C, Koletzko, B, Peissner, W. Aqueous normal phase chromatography improves quantification and qualification of homocysteine, cysteine and methionine by liquid chromatography-tandem mass spectrometry. J Chromatogr, B: Anal Technol Biomed Life Sci 2011;879:83–9, https://doi.org/10.1016/j.jchromb.2010.11.016.Search in Google Scholar PubMed
20. Jiang, Y, Mistretta, B, Elsea, S, Sun, Q. Simultaneous determination of plasma total homocysteine and methionine by liquid chromatography-tandem mass spectrometry. Clin Chim Acta 2017;464:93–7, https://doi.org/10.1016/j.cca.2016.11.017.Search in Google Scholar PubMed
21. Satterfield, MB, Sniegoski, LT, Welch, MJ, Nelson, BC, Pfeiffer, CM. Comparison of isotope dilution mass spectrometry methods for the determination of total homocysteine in plasma and serum. Anal Chem 2003;75:4631–8, https://doi.org/10.1021/ac034207x.Search in Google Scholar PubMed
22. Liu, Y, Song, D, Xu, B, Li, H, Dai, X, Chen, B. Development of a matrix-based candidate reference material of total homocysteine in human serum. Anal Bioanal Chem 2017;409:3329–35, https://doi.org/10.1007/s00216-017-0272-3.Search in Google Scholar PubMed
23. Tomaiuolo, M, Vecchione, G, Margaglione, M, Pisanelli, D, Grandone, E. Stable-isotope dilution LC-ESI-MS/MS techniques for the quantification of total homocysteine in human plasma. J Chromatogr, B: Anal Technol Biomed Life Sci 2009;877:3292–9, https://doi.org/10.1016/j.jchromb.2009.07.024.Search in Google Scholar PubMed
24. Satterfield, MB, Sniegoski, LT, Sharpless, KE, Welch, MJ, Hornikova, A, Zhang, NF, et al.. Development of a new standard reference material: SRM 1955 (homocysteine and folate in human serum). Anal Bioanal Chem 2006;385:612–22, https://doi.org/10.1007/s00216-006-0434-1.Search in Google Scholar PubMed
25. Rossi, E, Beilby, JP, McQuillan, BM, Hung, J. Biological variabiity and reference intervals for total plasma homocysteine. Ann Clin Biochem 1999;36:56–61. https://doi.org/10.1177/000456329903600107.Search in Google Scholar PubMed
Supplementary Material
The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2022-0388).
© 2022 Walter de Gruyter GmbH, Berlin/Boston