Automated Competitive Protein-Binding Assay for Total 25-OH Vitamin D, Multicenter Evaluation and Practical Performance

Journal of Clinical Laboratory Analysis

Volumn 29, Issue 6, 2015, Pages 451-461

  Wielders, Jos P M ^a   Carter, Graeme F ^b   Eberl, Heike ^c   Morris, Gary ^b   Jürgen Roth, Heinz ^d   Vogl, Christian ^c  

^a MEANDER MEDICAL CENTER   (Netherlands)

^b Healthscope Pathology ^*  (Australia)

^c ROCHE DIAGNOSTICS GMBH   (Germany)

^d Limbach Laboratory   (Germany)

Author keywords

25 hydroxyvitamin D; Elecsys vitamin D total; Electrochemiluminescence; Robustness; VDBP; Vitamin D; Vitamin D binding protein

Indexed keywords

25 HYDROXYVITAMIN D; 25 HYDROXYERGOCALCIFEROL; PROTEIN BINDING; VITAMIN D BINDING PROTEIN;

ACCURACY; ARTICLE; BLOOD SAMPLING; COMPETITIVE BINDING ASSAY; CONTROLLED STUDY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; IMMUNOASSAY; IMMUNOASSAY ANALYZER; INTERMETHOD COMPARISON; LIQUID CHROMATOGRAPHY; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; TANDEM MASS SPECTROMETRY; AUTOMATION; BINDING COMPETITION; BLOOD ANALYSIS; CLINICAL TRIAL; DIAGNOSTIC TEST; EVALUATION STUDY; METABOLISM; MULTICENTER STUDY; PROCEDURES; STANDARDS;

25-HYDROXYVITAMIN D 2; AUTOMATION; BINDING, COMPETITIVE; BLOOD CHEMICAL ANALYSIS; CHROMATOGRAPHY, LIQUID; DIAGNOSTIC TESTS, ROUTINE; HUMANS; PROTEIN BINDING; TANDEM MASS SPECTROMETRY; VITAMIN D-BINDING PROTEIN;

EID: 85000023995     PISSN: 08878013     EISSN: 10982825     Source Type: Journal    
DOI: 10.1002/jcla.21793     Document Type: Article

References (40)

1. Christakos S, Ajibade DV, Dhawan P, Fechner AJ, Mady LJ. Vitamin D: Metabolism. Endocrinol Metab Clin North Am 2010;39:243-253.
2. Farrell CJL, 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;58:531-542.
3. Holick MF. Vitamin D deficiency. N Engl J Med 2007;357:266-281.
4. Wang Y, Zhu J, DeLuca HF. Where is the vitamin D receptor? Arch Biochem Biophys 2012;523:123-133.
5. Phinney KW, Bedner M, Tai SS, et al. Development and certification of a standard reference material for vitamin D metabolites in human serum. Anal Chem 2012;84:956-962.
6. Holick MF, Chen TC, Lu Z, Sauter E. Vitamin D and skin physiology: A D-lightful story. J Bone Miner Res 2007;22(S2):V28-V33.
7. Carter GD. 25-hydroxyvitamin D. A difficult analyte. Clin Chem 2012;58:486-488.
8. Hart GR, Furniss JL, Laurie D, Durham SK. Measurement of vitamin D status: Background, clinical use, and methodologies. Clin Lab 2006;52:335-343.
9. Houghton LA, Vieth R. The case against ergocalciferol (vitamin D2) as a vitamin supplement. Am J Clin Nutr 2006;84:694-697.
10. Bischoff-Ferrari HA, Giovannucci E, Willett WC, Dietrich T, Dawson-Hughes B. Estimation of optimal serum concentrations of 25-hydroxyvitamin D for multiple health outcomes. Am J Clin Nutr 2006;84:18-28.
11. Ross AC, Taylor CL, Yaktine AL, Del Valle HB for the Institute of Medicine of the National Academies Committee to Review Dietary Reference Intakes for Vitamin D and Calcium. Dietary reference intakes for calcium and vitamin D. Washington, D.C.: 2010. www.iom.edu/vitamind -Last accessed 28 October 2012.
12. Dawson-Hughes B, Mithal A, Bonjour J-P, Boonen S, Burckhardt P, Fuleihan F, et al. IOF position statement: Vitamin D recommendations for older adults. Osteoporos Int 2010;21:1151-1154.
13. Holick MF, Binkley NC, Bischoff-Ferrari HA, et al. Evaluation, treatment, and prevention of vitamin D deficiency: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2011;96:1911-1930.
14. Carter GD. Accuracy of 25-hydroxyvitamin D assays: Confronting the issues. Curr Drug Targets 2011;12:19-28.
15. Lai JKC, Lucas RM, Clements MS, Harrison SL, Banks E. Assessing vitamin D status: Pitfalls for the unwary. Mol Nutr Food Res 2010;54:1062-1071.
16. Higashi T, Shimada K, Toyo'oka T. Advances in determination of vitamin D related compounds in biological samples using liquid chromatography-mass spectrometry: A review. J Chromatogr B 2010;878:1654-1661.
17. Ong L, Saw S, Sahabdeen NB, Tey KT, Ho CS, Sethi SK. Current 25-hydroxyvitamin D assays: Do they pass the test? Clin Chim Acta 2012;413:1127-1134.
18. Sempos CT, Vesper HW, Phinney KW, Thienpont LM, Coates PM, VDSP. Vitamin D status as an international issue: National surveys and the problem of standardization. Scand J Clin Lab Invest 2012;72(S243):32-40.
19. Thienpont LM, Stepman HCM, Vesper HW. Standardization of measurements of 25-hydroxyvitamin D3 and D2. Scand J Clin Lab Invest 2012;243(S243):41-49.
20. Erler K. Elecsys immunoassay systems using electrochemiluminescence detection. Wien Klin Wochenschr 1998;110(S3):5-10.
21. Phinney KW. Development of a standard reference material for vitamin D in serum. Am J Clin Nutr 2008;88(Suppl):511S-512S.
22. Vogeser M, Kyriatsoulis A, Huber E, Kobold U. Candidate reference method for the quantification of circulating 25-hydroxyvitamin D3 by liquid chromatography-tandem mass spectrometry. Clin Chem 2004;50:1415-1417.
23. Deutsche Vereinte Gesellschaft fuer Klinische Chemie und Laboratoriumsmedizin. 25-Hydroxy-Vitamin D3 LC-MS/MS Referenzmethode: 2006 http://www.dgkl.de/PA100126_DE_VAR100100 -Last accessed 100129 August 102012.
24. CLSI. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition. CLSI document EP05-A2. Wayne, PA: Clinical Laboratory Standards Institute; 2004.
25. Ding S, Schoenmakers I, Jones K, Koulman A, Prentice A, Volmer DA. Quantitative determination of vitamin D metabolites in plasma using UHPLC-MS/MS. Anal Bioanal Chem 2010;398:779-789.
26. U.S. Food and Drug Administration. 510(k) premarket notification [database on the Internet]. 2012 [cited 08 October 2012]. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm.
27. Passing H, Bablok W. A new biometrical procedure for testing the equality of measurements from two different analytical methods. Application of linear regression procedures for method comparison studies in clinical chemistry, Part I. J Clin Chem Clin Biochem 1983;21:709-720.
28. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986;1:307-310.
29. 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;58:543-548.
30. Stepman HCM, Vanderroost A, Stockl 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;49:253-256.
31. 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.
32. Knudsen CS, Nexo E, Hojskov CS, Heickendorff L. Analytical validation of the Roche 25-OH vitamin D total assay. Clin Chem Lab Med 2012;50:1965-1968.
33. van den Ouweland JMW, Beijers AM, Demacker PNM, 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 2010;878:1163-1168.
34. Kelley JM, Melanson SEF, Snyder ML, Cremers S, Jarolim P. Method comparison of a 25-hydroxy vitamin D enzyme immunoassay to liquid chromatography tandem mass spectroscopy. Clin Chem Lab Med 2012;50:1137-1138.
35. El-Khoury JM, Reineks EZ, Wang S. Progress of liquid chromatography-mass spectrometry in measurement of vitamin D metabolites and analogues. Clin Biochem 2011;44:66-76.
36. Farrell C, Soldo J, Williams P, Herrmann M. 25-Hydroxyvitamin D testing: Challenging the performance of current automated immunoassays. Clin Chem Lab Med 2012;50:1953-1963.
37. Le Goff C, Peeters S, Crine Y, Lukas P, Souberbielle JC, Cavalier E. Evaluation of the cross-reactivity of 25-hydroxyvitamin D2 on seven commercial immunoassays on native samples. Clin Chem Lab Med 2012;50:2031-2032.
38. 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;52:373-380.
39. Herrmann M. The measurement of 25-hydroxy vitamin D - An analytical challenge. Clin Chem Lab Med 2012;50:1873-1875.
40. Emmen JM, Wielders JPM, Boer AK, van den Ouweland JMW, Vader HL. The new Roche Vitamin D Total assay: Fit for its purpose? Clin Chem Lab Med 2012;50:1969-1972.