Toward Clarity in Clinical Vitamin D Status Assessment: 25(OH)D Assay Standardization

Endocrinology and Metabolism Clinics of North America

Volumn 46, Issue 4, 2017, Pages 885-899

  Binkley, Neil ^a   Carter, Graham D ^b  

^a UNIVERSITY OF WISCONSIN MADISON   (United States)

^b CHARING CROSS HOSPITAL   (United Kingdom)

Author keywords

25 Hydroxyvitamin D; National Institute of Standards and Technology; Office of Dietary Supplements; Standardization harmonization; Vitamin D; Vitamin D External Quality Assessment Scheme; Vitamin D Standardization Program

Indexed keywords

25 HYDROXYVITAMIN D; VITAMIN D; 25-HYDROXYVITAMIN D;

CLINICAL EFFECTIVENESS; HUMAN; LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY; NUTRIENT AVAILABILITY; NUTRITIONAL ASSESSMENT; NUTRITIONAL STATUS; OUTCOME ASSESSMENT; PRIORITY JOURNAL; REVIEW; STANDARDIZATION; TANDEM MASS SPECTROMETRY; VITAMIN BLOOD LEVEL; VITAMIN D DEFICIENCY; VITAMIN METABOLISM; VITAMIN SUPPLEMENTATION; ANALOGS AND DERIVATIVES; BLOOD; LIQUID CHROMATOGRAPHY; STANDARD;

CHROMATOGRAPHY, LIQUID; HUMANS; REFERENCE STANDARDS; TANDEM MASS SPECTROMETRY; VITAMIN D; VITAMIN D DEFICIENCY;

EID: 85030474710     PISSN: 08898529     EISSN: 15584410     Source Type: Journal    
DOI: 10.1016/j.ecl.2017.07.012     Document Type: Review

References (46)

1. Hollis, B.W., Wagner, C.L., Clinical review: the role of the parent compound vitamin D with respect to metabolism and function: why clinical dose intervals can affect clinical outcomes. J Clin Endocrinol Metab 98:12 (2013), 4619–4628.
2. Binkley, N., Borchardt, G., Siglinsky, E., et al. Does vitamin D metabolite measurement help predict 25(OH)D change following vitamin D supplementation?. Endocr Pract 23:4 (2017), 432–441.
3. Ross, A.C., Taylor, C.L., Yakine, A.L., et al. Report on dietary reference intakes for vitamin D and calcium. 2011, Institute of Medicine. The National Academies Press, Washington, DC.
4. Holick, M.F., Binkley, N.C., Bischoff-Ferrari, H.A., et al. Guidelines for preventing and treating vitamin D deficiency and insufficiency revisited. J Clin Endocrinol Metab 97 (2012), 1153–1158.
5. Scientific Advisory Committee on Nutrition (SACN). SACN vitamin D and health report. 2016, Public Health England, London.
6. de la Hunty, A., Wallace, A.M., Gibson, S., et al. UK foods standards agency workshop consensus report: the choice of method for measuring 25-hydroxyvitamin D to estimate vitamin D status for the UK National Diet and Nutrition Survey. Br J Nutr 104 (2010), 612–619.
7. Wallace, A.M., Gibson, S., de la Hunty, A., et al. Measurement of 25-hydroxyvitamin D in the clinical laboratory: current procedures, performance characteristics and limitations. Steroids 75 (2010), 477–488.
8. Carter, G.D., Carter, R., Jones, J., et al. How accurate are assays for 25-hydroxyvitamin D? Data from the international vitamin D external quality assessment scheme. Clin Chem 50 (2004), 2195–2197.
9. Binkley, N., Krueger, D., Cowgill, C.S., et al. Assay variation confounds the diagnosis of hypovitaminosis D: a call for standardization. J Clin Endocrinol Metab 89:7 (2004), 3152–3157.
10. Binkley, N., Dawson-Hughes, B., Durazo-Arvizu, R., et al. Vitamin D measurement standardization: the way out of the chaos. J Steroid Biochem Mol Biol 173 (2017), 117–121.
11. Le Goff, C., Cavalier, E., Souberbielle, J.-C., et al. Measurement of circulating 25-hydroxyvitamin D: a historical review. Pract Lab Med 2 (2015), 1–14.
12. Sempos, C.T., Vesper, H.W., Phinney, K.W., et al. Vitamin D status as an international issue: National surveys and the problem of standardization. Scand J Clin Lab Invest 72:S243 (2012), 32–40.
13. Haddad, J.G., Chyu, K.J., Competitive protein-binding radioassay for 25-hydroxycholecalciferol. J Clin Endocrinol Metab 33 (1971), 992–995.
14. Belsey, R.E., DeLuca, H.F., Potts, J.T., A rapid assay for 25-(OH)vitamin D3 without preparative chromatography. J Clin Endocrinol Metab 38 (1974), 1046–1051.
15. Carter, G.D., Jones, J.C., Berry, J.L., The anomalous behaviour of exogenous 25-hydroxyvitamin D in competitive binding assays. J Steroid Biochem Mol Biol 103:3–5 (2007), 480–482.
16. Jones, G.R.D., Jackson, C., The Joint Committee for Traceability in Laboratory Medicine (JCTLM) - its history and operation. Clin Chim Acta 453 (2016), 86–94.
17. Anonymous. SRM 972a - Vitamin D metabolites in frozen human serum. Standard reference materials. Available at: https://catalog.data.gov/dataset/srm-972a-vitamin-d-metabolites-in-frozen-human-serum. Accessed March 31, 2017.
18. Tai, S.S., Nelson, M.A., Candidate reference measurement procedure for the determination of (24R),25-dihydroxyvitamin D3 in human serum using isotope-dilution liquid chromatography-tandem mass spectrometry. Anal Chem 87:15 (2015), 7964–7970.
19. Heijboer, A.C., Blankenstein, M.A., Kema, I.P., et al. Accuracy of 6 routine 25-hydroxyvitamin D assays: influence of vitamin D binding protein concentration. Clin Chem 58:3 (2012), 543–548.
20. Shah, I., James, R., Barker, J., et al. Misleading measures in vitamin D analysis: a novel LC-MS/MS assay to account for epimers and isobars. Nutr J, 10, 2011, 46.
21. Vesper, H.W., Thienpont, L.M., Traceability in laboratory medicine. Clin Chem 55:6 (2009), 1067–1075.
22. Myers, G.L., Introduction to standardization of laboratory results. Steroids 73:13 (2008), 1293–1296.
23. Greg Miller, W., Myers, G.L., Lou Gantzer, M., et al. Roadmap for harmonization of clinical laboratory measurement procedures. Clin Chem 57:8 (2011), 1108–1117.
24. Tai, S.S.C., Bedner, M., Phinney, K.W., Development of a candidate reference measurement procedure for the determination of 25-hydroxyvitamin D3 and 25-hydroxyvitamin D2 in human serum using isotope-dilution liquid chromatography-tandem mass spectrometry. Anal Chem 82 (2010), 1942–1948.
25. Thienpont, L.M., Stepman, H.C., Vesper, H.W., Standardization of measurements of 25-hydroxyvitamin D3 and D2. Scand J Clin Lab Invest 72:S243 (2012), 41–49.
26. Mineva, E.M., Schleicher, R.L., Chaudhary-Webb, M., et al. A candidate reference measurement procedure for quantifying serum concentrations of 25-hydroxyvitamin D(3) and 25-hydroxyvitamin D(2) using isotope-dilution liquid chromatography-tandem mass spectrometry. Anal Bioanal Chem 407:19 (2015), 5615–5624.
27. Stepman, H.C., Vanderroost, A., Van Uytfanghe, K., et al. Candidate reference measurement procedures for serum 25-hydroxyvitamin D3 and 25-hydroxyvitamin D2 by using isotope-dilution liquid chromatography-tandem mass spectrometry. Clin Chem 57:3 (2011), 441–448.
28. Binkley, N., Sempos, C.T., Standardizing vitamin D assays: the way forward. J Bone Miner Res 29:8 (2014), 1709–1714.
29. Sempos, C.T., Carter, G.D., Merkel, J.M., et al. The path to serum total 25-hydroxyvitamin D assay standardization. Austin J Nutr Metab, 3(2), 2016, 1039.
30. College of American Pathologists. Accuracy-based vitmain D (ABVD). Proficiency testing/EQA 2016. Available at: https://estore.cap.org. Accessed February 22, 2016.
31. DEQAS (Vitamin D external quality assessment scheme). Available at: http://www.deqas.org/. Accessed August 9, 2016.
32. Stockl, D., Sluss, P.M., Thienpont, L.M., Specifications for trueness and precision of a reference measurement system for serum/plasma 25-hydroxyvitamin D analysis. Clin Chim Acta 408:1–2 (2009), 8–13.
33. Cashman, K.D., Kiely, M., Kinsella, M., et al. Evaluation of vitamin D standardization program protocols for standardizing serum 25-hydroxyvitamin D data: a case study of the program's potential for national nutrition and health surveys. Am J Clin Nutr 97:6 (2013), 1235–1242.
34. Sarafin, K., Durazo-Arvizu, R., Tian, L., et al. Standardizing 25-hydroxyvitamin D values from the Canadian health measures survey. Am J Clin Nutr 102:5 (2015), 1044–1050.
35. Cashman, K.D., Dowling, K.G., Skrabakova, Z., et al. Standardizing serum 25-hydroxyvitamin D data from four Nordic population samples using the vitamin D standardization program protocols: shedding new light on vitamin D status in Nordic individuals. Scand J Clin Lab Invest 75:7 (2015), 549–561.
36. Cashman, K.D., Dowling, K.G., Skrabakova, Z., et al. Vitamin D deficiency in Europe: pandemic?. Am J Clin Nutr 103:4 (2016), 1033–1044.
37. Schleicher, R.L., Sternberg, M.R., Lacher, D.A., et al. The vitamin D status of the US population from 1988 to 2010 using standardized serum concentrations of 25-hydroxyvitamin D shows recent modest increases. Am J Clin Nutr 104:2 (2016), 454–461.
38. Healy, M.J.R., Outliers in clinical chemistry quality-control schemes. Clin Chem 25 (1979), 675–677.
39. Leventis, P., Garrison, L., Sibley, M., et al. Underestimation of serum 25-hydroxyvitamin D by the Nichols advantage assay in patients receiving vitamin D replacement therapy. Clin Chem 51:6 (2005), 1072–1074 [author reply: 1074].
40. Holick, M.F., Binkley, N., Bischoff-Ferrari, H.A., et al. Evaluation, treatment, and prevention of vitamin D deficiency: an endocrine society clinical practice guideline. J Clin Endocrinol Metab 96 (2011), 1911–1930.
41. Heaney, R.P., Guidelines for optimizing design and analysis of clinical studies of nutrient effects. Nutr Rev 72:1 (2014), 48–54.
42. 2 in humans. J Clin Endocrinol Metab, 2011, 10.1210/jc.2010-2230.
43. Gaksch, M., Jorde, R., Grimnes, G., et al. Vitamin D and mortality: Individual participant data meta-analysis of standardized 25-hydroxyvitamin D in 26916 individuals from a European consortium. PLoS One, 12(2), 2017, e0170791.
44. Luxwolda, M.F., Kuipers, R.S., Kema, I.P., et al. Traditionally living populations in East Africa have a mean serum 25-hydroxyvitamin D concentration of 115 nmol/L. Br J Nutr 108 (2012), 1557–1561.
45. Binkley, N., Novotny, R., Krueger, D., et al. Low vitamin D status despite abundant sun exposure. J Clin Endocrinol Metab 92 (2007), 2130–2135.
46. Miljkovic, I., Bodnar, L.M., Cauley, J.A., et al. Low prevalence of vitamin D deficiency in elderly Afro-Caribbean men. Ethn Dis 21:1 (2011), 79–84.