Evaluation of 3-epi-25-hydroxyvitamin D3 cross-reactivity in the Roche Elecsys Vitamin D Total protein binding assay
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Johannes M.W. van den Ouweland
,
Antonius M. Beijers
Abstract
Background: Presence of the 3-epi-25-hydroxyvitamin D3 [3-epi-25(OH)D3] metabolite affects accurate determination of 25(OH)D3 by most routine liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods and to an unknown extent in present immuno- and protein binding assays. We studied 3-epi-25(OH)D3 cross-reactivity in a competitive protein binding (CPB) assay (Roche Elecsys).
Methods: Neonatal samples, containing up to 58% of 3-epi-25(OH)D3 were used for measurement by the CPB assay and by an LC-MS/MS method separating 25(OH)D3 and 3-epi-25(OH)D3. Analytical recovery was also studied by addition of exogenous 3-epi-25(OH)D3.
Results: The CPB assay showed approximately 51% cross-reactivity to 3-epi-25(OH)D3 at exogenous addition. In contrast, there was minimal 3-epi-25(OH)D3 recognition by the CPB assay when present as the natural endogenous metabolite.
Conclusions: The automated CPB assay displays minimal 3-epi-25(OH)D3 cross-reactivity in samples containing significant concentrations of endogenous 3-epi-25(OH)D3. Exogenous 3-epi-25(OH)D3 added to human serum or plasma seems to behave different from endogenous presence, and caution is warranted when using samples spiked with vitamin D metabolites for testing analytical specificity or external quality assurance in immuno- or protein binding assays.
Roche Diagnostics is acknowledged for providing some kits employed for the CPB assay. We thank L Tax for performing the immunoassay analysis, thank colleagues from several Dutch laboratories for providing us human sera with high 25(OH)D3 concentration. We finally thank the DEQAS organisation for providing us with additional samples having values assigned by the NIST reference measurement procedure.
Conflict of interest statement
Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article. Research funding played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
References
1. Vitamin D external quality assessment scheme (DEQAS) 25-OHD report, April 2013 distribution. London, UK: Charing Cross Hospital, 2013.Suche in Google Scholar
2. Roth HJ, Schmidt-Gayk H, Weber H, Niederau C. Accuracy and clinical implications of seven 25-hydroxyvitamin D methods compared with liquid chromatography-tandem mass spectrometry as a reference. Ann Clin Biochem 2008;45:153–9.10.1258/acb.2007.007091Suche in Google Scholar PubMed
3. Farrell C-JL, Martin S, McWhinney B, Straub I, Williams P, Herrmann M. State-of-the-art vitamin D assays: a comparison of automated immunoassays with liquid chromatography-tandem mass spectrometry methods. Clin Chem 2012;58:531–42.10.1373/clinchem.2011.172155Suche in Google Scholar PubMed
4. Heijboer AC, Blankenstein MA, Kema IP, Buijs MM. Accuracy of 6 routine 25-hydroxyvitamin D assays: influence of vitamin D binding protein concentration. Clin Chem 2012;58:543–8.10.1373/clinchem.2011.176545Suche in Google Scholar PubMed
5. Janssen MJ, Wielders JP, Bekker CC, Boesten LS, Buijs MM, Heijboer AC, et al. Multicenter comparison study of current methods to measure 25-hydroxyvitamin D in serum. Steroids 2012;77:1366–72.10.1016/j.steroids.2012.07.013Suche in Google Scholar PubMed
6. Singh RJ, Taylor RL, Reddy GS, Grebe SK. C-3 epimers can account for a significant proportion of total circulating 25-hydroxyvitamin D in infants, complicating accurate measurement and interpretation of vitamin D status. J Clin Endocrinol Metab 2006;91:3055–61.10.1210/jc.2006-0710Suche in Google Scholar PubMed
7. Lensmeyer GL, Wiebe DA, Binkley N, Drezner MK. HPLC method for 25-hydroxyvitamin D measurement: comparison with contemporary assays. Clin Chem 2006;52:1120–6.10.1373/clinchem.2005.064956Suche in Google Scholar PubMed
8. Stepman HC, Vanderroost A, Stöckl D, Thienpont LM. Full-scan mass spectral evidence for 3-epi-25-hydroxyvitamin D3 in serum of infants and adults. Clin Chem Lab Med 2011;49:253–6.10.1515/CCLM.2011.050Suche in Google Scholar PubMed
9. Van den Ouweland JM, Beijers AM, van Daal H. Fast separation of 25-hydroxyvitamin D3 from 3-epi-25-hydroxyvitamin D3 in human serum by liquid chromatography-tandem mass spectrometry: variable prevalence of 3-epi-25-hydroxyvitamin D3 in infants, children, and adults. Clin Chem 2011;57:1618–9.10.1373/clinchem.2011.170282Suche in Google Scholar PubMed
10. Bailey D, Veljkovic K, Yazdanpanah M, Adeli K. Analytical measurement and clinical relevance of vitamin D3 C3-epimer. Clin Biochem 2013;46:190–6.10.1016/j.clinbiochem.2012.10.037Suche in Google Scholar PubMed
11. Van den Ouweland JM, Beijers AM, Demacker PN, van Daal H. Measurement of 25-OH-vitamin D in human serum using liquid chromatography tandem-mass spectrometry with comparison to radioimmunoassay and automated immunoassay. J Chromatogr B Analyt Technol Biomed Life Sci 2010;878:1163–8.10.1016/j.jchromb.2010.03.035Suche in Google Scholar PubMed
12. Emmen JM, Wielders JP, Boer AK, van den Ouweland JM, Vader HL. The new Roche Vitamin D Total assay: fit for its purpose? Clin Chem Lab Med 2012;50:1969–72.10.1515/cclm-2011-0085Suche in Google Scholar
13. Knudsen CS, Nexo E, Højskov CS, Heickendorff L. Analytical validation of the Roche 25-OH Vitamin D Total assay. Clin Chem Lab Med 2012;50:1965–8.10.1515/cclm-2011-0964Suche in Google Scholar
14. Brown AJ, Ritter C, Slatopolsky E, Muralidharan KR, Okamura WH, Reddy GS. 1α,25-dihydroxy-3-epi-vitamin D3, a natural metabolite of 1α,25-dihydroxyvitamin D3, is a potent suppressor of parathyroid hormone secretion. J Cell Biochem 1999;73:106–13.10.1002/(SICI)1097-4644(19990401)73:1<106::AID-JCB12>3.0.CO;2-QSuche in Google Scholar
15. Fleet JC, Bradley J, Reddy GS, Ray R, Wood RJ. 1α,25-(OH)2-vitamin D3 analogs with minimal in vivo calcemic activity can stimulate significant transepithelial calcium transport and mRNA expression in vitro. Arch Biochem Biophys 1996;329:228–34.10.1006/abbi.1996.0213Suche in Google Scholar
16. Vitamin D external quality assessment scheme (DEQAS) 25-OHD report, October 2011 distribution. London, UK: Charing Cross Hospital, 2011.Suche in Google Scholar
17. Horst RL. Exogenous versus endogenous recovery of 25-hydroxyvitamins D2 and D3 in human samples using high-performance liquid chromatography and the DiaSorin LIAISON Total-D Assay. J Steroid Biochem Mol Biol 2010;121:180–2.10.1016/j.jsbmb.2010.03.010Suche in Google Scholar
18. Kamao M, Tatematsu S, Hatakeyama S, Sakaki T, Sawada N, Inouye K, et al. C-3 epimerization of vitamin D3 metabolites and further metabolism of C-3 epimers: 25-hydroxyvitamin D3 is metabolized to 3-epi-25-hydroxyvitamin D3 and subsequently metabolized through C-1α or C-24 hydroxylation. J Biol Chem 2004;279:15897–907.10.1074/jbc.M311473200Suche in Google Scholar
19. Carter GD, Jones JC, Berry JL. The anomalous behaviour of exogenous 25-hydroxyvitamin D in competitive binding assays. J Steroid Biochem Mol Biol 2007;103:480–2.10.1016/j.jsbmb.2006.11.007Suche in Google Scholar
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- Point of care testing: evolving scenarios and innovative perspectives
- Review
- Point-of-care testing: where is the evidence? A systematic survey
- Mini Review
- Vulnerability of point-of-care test reagents and instruments to environmental stresses: implications for health professionals and developers
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