Evaluation of four automated clinical analyzers for the determination of total 25(OH)D in comparison to a certified LC-MS/MS.
25(OH)D
CDC
LC-MS/MS
Milan model 1
Vitamin D Standardization-Certification Program (VDSCP)
immunoassay
vitamin D
Journal
Clinical chemistry and laboratory medicine
ISSN: 1437-4331
Titre abrégé: Clin Chem Lab Med
Pays: Germany
ID NLM: 9806306
Informations de publication
Date de publication:
26 07 2023
26 07 2023
Historique:
received:
07
11
2022
accepted:
06
02
2023
medline:
3
7
2023
pubmed:
15
2
2023
entrez:
14
2
2023
Statut:
epublish
Résumé
The aim of this study was to compare the results of five methods for the determination of total 25(OH)D. For that purpose, two mass spectrometry and three immunoassay methods were used. A total of 124 serum samples were analyzed on five different methods (i.e., a reference LC-MS/MS, Cascadion, Lumipulse, Roche Elecsys II and Roche Elecsys III). Analytical performance against LC-MS/MS was evaluated and compared to the Milan models 1 (analytical performance based on the clinical outcome using thresholds of 12, 20 and 30 ng/mL) and 2 (analytical performance based on biological variation). Additionally, imprecision studies and accuracy using NIST SRM972a samples were carried out. Compared to the reference LC-MS/MS method, the Lumipulse and the Roche Elecsys III assays reached the optimal criterion for bias, while the Cascadion met the desirable one. The Roche Elecsys II was not able to reach the minimal criteria. The proportion of correctly classified patients was higher using the Cascadion (95.2%) compared to the three immunoassays. In addition to its better precision, the Cascadion was not impacted by a high concentration of 3-epi-25(OH)D Compared to the LC-MS/MS reference method, the Cascadion presented the highest level of concordance at medical decision cut-offs for total 25(OH)D and reached the desirable specification for bias. Moreover, the presence of 3-epi-25(OH)D
Identifiants
pubmed: 36785905
pii: cclm-2022-1129
doi: 10.1515/cclm-2022-1129
doi:
Substances chimiques
25-hydroxyvitamin D
A288AR3C9H
Vitamin D
1406-16-2
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1420-1427Informations de copyright
© 2023 Walter de Gruyter GmbH, Berlin/Boston.
Références
Rifai, N, Horvath, A, Wittwer, C. Tietz textbook of clinical chemistry and molecular diagnostics , 6th ed. St. Louis, Missouri: Elsevier; 2018.
Bischoff-Ferrari, HA, Dawson-Hughes, B, Stocklin, E, Sidelnikov, E, Willett, WC, Edel, JO, et al.. Oral supplementation with 25(OH)D3 versus vitamin D3: effects on 25(OH)D levels, lower extremity function, blood pressure, and markers of innate immunity. J Bone Miner Res 2012;27:160–9. https://doi.org/10.1002/jbmr.551 .
doi: 10.1002/jbmr.551
Dawson-Hughes, B, Mithal, A, Bonjour, JP, Boonen, S, Burckhardt, P, Fuleihan, GE, et al.. IOF position statement: vitamin D recommendations for older adults. Osteoporos Int 2010;21:1151–4. https://doi.org/10.1007/s00198-010-1285-3 .
doi: 10.1007/s00198-010-1285-3
Holick, MF, Binkley, NC, Bischoff-Ferrari, HA, Gordon, CM, Hanley, DA, Heaney, RP, et al.. Evaluation, treatment, and prevention of vitamin D deficiency: an endocrine society clinical practice guideline. J Clin Endocrinol Metab 2011;96:1911–30. https://doi.org/10.1210/jc.2011-0385 .
doi: 10.1210/jc.2011-0385
Pittas, AG, Sun, Q, Manson, JE, Dawson-Hughes, B, Hu, FB. Plasma 25-hydroxyvitamin D concentration and risk of incident type 2 diabetes in women. Diabetes Care 2010;33:2021–3. https://doi.org/10.2337/dc10-0790 .
doi: 10.2337/dc10-0790
Ross, AC, Manson, JE, Abrams, SA, Aloia, JF, Brannon, PM, Clinton, SK, et al.. The 2011 report on dietary reference intakes for calcium and vitamin D from the institute of medicine: what clinicians need to know. J Clin Endocrinol Metab 2011;96:53–8. https://doi.org/10.1210/jc.2010-2704 .
doi: 10.1210/jc.2010-2704
Souberbielle, JC, Body, JJ, Lappe, JM, Plebani, M, Shoenfeld, Y, Wang, TJ, et al.. Vitamin D and musculoskeletal health, cardiovascular disease, autoimmunity and cancer: recommendations for clinical practice. Autoimmun Rev 2010;9:709–15. https://doi.org/10.1016/j.autrev.2010.06.009 .
doi: 10.1016/j.autrev.2010.06.009
De Niet, S, Tremege, M, Coffiner, M, Rousseau, AF, Calmes, D, Frix, AN, et al.. Positive effects of vitamin D supplementation in patients hospitalized for COVID-19: a randomized, double-blind, placebo-controlled trial. Nutrients 2022;14:3048. https://doi.org/10.3390/nu14153048 .
doi: 10.3390/nu14153048
Altieri, B, Cavalier, E, Bhattoa, HP, Perez-Lopez, FR, Lopez-Baena, MT, Perez-Roncero, GR, et al.. Vitamin D testing: advantages and limits of the current assays. Eur J Clin Nutr 2020;74:231–47. https://doi.org/10.1038/s41430-019-0553-3 .
doi: 10.1038/s41430-019-0553-3
Farrell, CJ, Herrmann, M. Determination of vitamin D and its metabolites. Best Pract Res Clin Endocrinol Metabol 2013;27:675–88. https://doi.org/10.1016/j.beem.2013.06.001 .
doi: 10.1016/j.beem.2013.06.001
Carter, G, Card, DJ. Chapter 3 – methods for assessment of vitamin D. In: Harrington, D, editor. Laboratory assessment of vitamin status . London: Academic Press; 2019:49–77 pp.
Benton, SC, Tetteh, GK, Needham, SJ, Mucke, J, Sheppard, L, Alderson, S, et al.. Evaluation of the 25-hydroxy vitamin D assay on a fully automated liquid chromatography mass spectrometry system, the thermo scientific cascadion SM clinical analyzer with the cascadion 25-hydroxy vitamin D assay in a routine clinical laboratory. Clin Chem Lab Med 2020;58:1010–7. https://doi.org/10.1515/cclm-2019-0834 .
doi: 10.1515/cclm-2019-0834
Seger, C, Salzmann, L. After another decade: LC-MS/MS became routine in clinical diagnostics. Clin Biochem 2020;82:2–11. https://doi.org/10.1016/j.clinbiochem.2020.03.004 .
doi: 10.1016/j.clinbiochem.2020.03.004
Aarsand, AK, Fernandez-Calle, P, Webster, C, Coskun, A, Gonzales-Lao, E, Diaz-Garzon, J, et al.. The EFLM biological variation database . Available from: https://biologicalvariation.eu/ [Accessed 15 Oct 2022].
Thienpont, LM, Stepman, HC, Vesper, HW. Standardization of measurements of 25-hydroxyvitamin D3 and D2. Scand J Clin Lab Invest Suppl 2012;243:41–9. https://doi.org/10.3109/00365513.2012.681950 .
doi: 10.3109/00365513.2012.681950
Fabregat-Cabello, N, Farre-Segura, J, Huyghebaert, L, Peeters, S, Le Goff, C, Souberbielle, JC, et al.. A fast and simple method for simultaneous measurements of 25(OH)D, 24,25(OH)2D and the vitamin D metabolite ratio (VMR) in serum samples by LC-MS/MS. Clin Chim Acta 2017;473:116–23. https://doi.org/10.1016/j.cca.2017.08.024 .
doi: 10.1016/j.cca.2017.08.024
Wise, SA, Tai, SS, Nelson, MA, Burdette, CQ, Camara, JE, Hoofnagle, AN, et al.. Interlaboratory comparison for the determination of 24,25-dihydroxyvitamin D(3) in human serum using liquid chromatography with tandem mass spectrometry. J AOAC Int 2017;100:1308–17. https://doi.org/10.5740/jaoacint.17-0183 .
doi: 10.5740/jaoacint.17-0183
CDC vitamin D standardization-certification program (CDC VDSCP) certified total 25-hydroxyvitamin D assays. From 2019 Q4 and forward. Available from: https://www.cdc.gov/labstandards/pdf/hs/CDC_Certified_Vitamin_D_Assays-508.pdf [Accessed 15 Oct 2022].
Braga, F, Panteghini, M. Performance specifications for measurement uncertainty of common biochemical measurands according to Milan models. Clin Chem Lab Med 2021;59:1362–8. https://doi.org/10.1515/cclm-2021-0170 .
doi: 10.1515/cclm-2021-0170
Stockl, D, Sluss, PM, Thienpont, LM. Specifications for trueness and precision of a reference measurement system for serum/plasma 25-hydroxyvitamin D analysis. Clin Chim Acta 2009;408:8–13. https://doi.org/10.1016/j.cca.2009.06.027 .
doi: 10.1016/j.cca.2009.06.027
Cavalier, E, Lukas, P, Bekaert, AC, Peeters, S, Le Goff, C, Yayo, E, et al.. Analytical and clinical evaluation of the new Fujirebio Lumipulse(R)G non-competitive assay for 25(OH)-vitamin D and three immunoassays for 25(OH)D in healthy subjects, osteoporotic patients, third trimester pregnant women, healthy African subjects, hemodialyzed and intensive care patients. Clin Chem Lab Med 2016;54:1347–55. https://doi.org/10.1515/cclm-2015-0923 .
doi: 10.1515/cclm-2015-0923
Giuliani, S, Corvetta, D, Lucchiari, M, Herrmann, M. Evaluation of the analytical and clinical performance of the Fujirebio Lumipulse(R) G 25-OH vitamin D assay. Ann Clin Biochem 2018;55:302–4. https://doi.org/10.1177/0004563217747637 .
doi: 10.1177/0004563217747637
Saleh, L, Mueller, D, von Eckardstein, A. Analytical and clinical performance of the new Fujirebio 25-OH vitamin D assay, a comparison with liquid chromatography-tandem mass spectrometry (LC-MS/MS) and three other automated assays. Clin Chem Lab Med 2016;54:617–25. https://doi.org/10.1515/cclm-2015-0427 .
doi: 10.1515/cclm-2015-0427
van den Ouweland, JM, Beijers, AM, van Daal, H, Elisen, MG, Steen, G, Wielders, JP. Evaluation of 3-epi-25-hydroxyvitamin D3 cross-reactivity in the Roche Elecsys vitamin D total protein binding assay. Clin Chem Lab Med 2014;52:373–80. https://doi.org/10.1515/cclm-2013-0702 .
doi: 10.1515/cclm-2013-0702
Favresse, J, Schiettecatte, J, Wolff, F, Cotton, F, Elsen, M, Eucher, C, et al.. Two-site evaluation of the Roche Elecsys vitamin D total III assay. Clin Chem Lab Med 2022;60:1598–606. https://doi.org/10.1515/cclm-2022-0177 .
doi: 10.1515/cclm-2022-0177