25-hydroxy-vitamin D status: Limitations in comparison and clinical interpretation of serum-levels across different assay methods

Clinical Laboratory

Volumn 60, Issue 9, 2014, Pages 1541-1550

  Enko, Dietmar ^a   Fridrich, Leo ^b   Rezanica, Erwin ^a   Stolba, Robert ^a   Ernst, Juliane ^c   Wendler, Iris ^c   Fabian, Daniel ^d   Hauptlorenz, Susanne ^a   Halwachs Baumann, Gabriele ^a  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

^b General Hospital Steyr   (Austria)

^c RECIPE Chemicals + Instruments GmbH   (Germany)

^d Viollier AG   (Switzerland)

Author keywords

25 hydroxy vitaniin D; Clinical interpretation; Method comparison

Indexed keywords

25 HYDROXYVITAMIN D; CALCIUM; PARATHYROID HORMONE; 25-HYDROXYVITAMIN D; BIOLOGICAL MARKER; DRUG DERIVATIVE; VITAMIN D;

ADULT; AGED; ARTICLE; CHEMILUMINESCENCE IMMUNOASSAY; CHEMOLUMINESCENCE; CONTROLLED STUDY; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; INTERMETHOD COMPARISON; LABORATORY TEST; MAJOR CLINICAL STUDY; MALE; RADIOIMMUNOASSAY; REFERENCE VALUE; TANDEM MASS SPECTROMETRY; VITAMIN BLOOD LEVEL; AUSTRIA; BLOOD; BLOOD ANALYSIS; COMPARATIVE STUDY; LUMINESCENCE; PREDICTIVE VALUE; PROSPECTIVE STUDY; QUALITY CONTROL; REPRODUCIBILITY; STANDARD; VITAMIN D DEFICIENCY;

AUSTRIA; BIOLOGICAL MARKERS; BLOOD CHEMICAL ANALYSIS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; HUMANS; LUMINESCENT MEASUREMENTS; PREDICTIVE VALUE OF TESTS; PROSPECTIVE STUDIES; QUALITY CONTROL; RADIOIMMUNOASSAY; REPRODUCIBILITY OF RESULTS; TANDEM MASS SPECTROMETRY; VITAMIN D; VITAMIN D DEFICIENCY;

EID: 84908099316     PISSN: 14336510     EISSN: None     Source Type: Journal    
DOI: 10.7754/Clin.Lab.2014.131114     Document Type: Article

References (37)

1. Tangpricha V, Judd SE, Kamen D, Li YC, Malabanan A. Vitamin d. Int J Endocrinol 2010; doi: 10.1155/2010/631052.
2. 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: 1911-30.
3. Kanekar A, Sharma M, Joshi VR. Vitamin d deficiency - A clinical spectrum: Is there a symptomatic nonosteomalacic state? Int J Endocrinol 2010; doi: 10.1155/2010/521457.
4. Chakhtoura M, Azar ST. The role of vitamin d deficiency in the incidence, progression, and complications of type 1 diabetes mellitus. Int J Endocrinol 2013; doi: 10.1155/2013/148673.
5. Papandreou D, Malindretos P, Karabouta Z, Rousso I. Possible health implications and low vitamin D status during childhood and adolescence: An updated mini review. Int J Endocrinol 2010; doi: 10.1155/2010/472173.
6. Hocher B, Reichetzeder C. Vitamin D and cardiovascular risk in postmenopausal women: How to translate preclinical evidence into benefit for patients. Kidney Int 2013;84: 9-11.
7. Emmen JM, Wielders JP, Boer AK, van den Ouweland JM, Vad-er HL. The new Roche Vitamin D Total assay: Fit for the purpose? Clin Chem Lab Med 2012;0: 1-4.
8. Holick MF. Vitamin D status: Measurement, interpretation, and clinical application. Ann Epidemiol 2009;19: 73-8.
9. Krasowski MD. Pathology consultation on vitamin D testing. Am J Clin Pathol 2011;136: 507-14.
10. Cavalier E, Fache W, Souberbielle JC. A randomised, double-blinded, placebo-controlled, parallel study of vitamin D3 supplementation with different schémas based on multiples of 25.000 IU doses. Int J Endocrinol 2013; doi: 10.1155/2013/327265.
11. Inda Filho AJ, Melamed ML. Vitamin D and Kidney disease: What we know and what we do not know. J Bras Nefrol 2013;35: 323-31.
12. Gonzalez EA, Sachdeva A, Oliver DA, Martin KJ. Vitamin D insufficiency and deficiency in chronic kidney disease. A single center observational study. Am J Nephrol 2004;24: 503-10.
13. Al-Badr W, Martin KJ. Vitamin D and kidney disease. Clin J Am Soc Nephrol 2008;3: 1555-60.
14. Report of a WHO Scientific Group. Prevention and management of osteoporosis. WHO Technical Report Series 2003;921: 1-192.
15. Gallagher JC, Sai AJ. Vitamin D insufficiency, deficiency, and bone health. J Clin Endocrinol and Metab 2010;95: 2630-3.
16. Snellman G, Melhus H, Gedeborg R, et al. Determining vitamin D status: A comparison between commercially available assays. PLoS One 2010;5: El 1555.
17. Jafri L, Khan AH, Siddiqui AA, et al. Comparison of high performance liquid chromatography, radio immunoassay and electro-chemiluminescence immunoassay for quantification of serum 25 hydroxy vitamin D. Clin Biochem 2011;44: 864-8.
18. Binkley N, Krueger D, Cowgill CS, et al. Assay variation confounds the diagnosis of hypovitaminosis D: A call for standardization. J Clin Endocrinol and Metab 2004;89: 3152-7.
19. Barake M, Daher RT, Salti 1, et al. 25-hydroxyvitamin D assay variations and impact on clinical decision making. J Clin Endocrinol Metab 2012;97: 835-43.
20. Connell AB, Jenkins N, Black M, Pasco JA, Kotowicz MA, Schneider HG. Overreporting of vitamin D deficiency with the Roche Elecsys Vitamin D3 (25-OH) method. Pathology 2011;43: 368-71.
21. Cavalier E, Huberty V, Cormier C, Souberbielle JC. Overestima-tion of the 25(OH)D serum concentration with the automated IDS EIA kit. J Bone Miner Res 2011 ;26: 434-6.
22. Carter GD. Accuracy of 25-hydroxyvitamin D assays: Confronting the issues. Curr Drug Targets 2011 ; 12: 19-28.
23. Carter GD. 25-hydroxyvitamin D: A difficult analyte. Clin Chem 2012;58: 486-8.
24. Binkley N, Krueger DC, Morgan S, Wiebe D. Current status of clinical 25-hydroxyvitamin D measurement: An assessment of between-laboratory agreement. Clin Chim Acta 2010;411: 1976-82.
25. de la Hunty A, Wallace AM, Gibson S, Viljakainen H, Lamberg-Allardt C, Ashwell M. UK Food 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 2010; 104: 612-9.
26. 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.
27. Shah I, James R, Barker J, Petroczi A, Naughton DP. Misleading measures in Vitamin D analysis: A novel LC-MS/MS assay to account for epimers and isobars. Nutr J 2011; doi: 10.1186/1475-2891-10-46.
28. Leung KS, Fong BM. LC-MS/MS in the routine clinical laboratory: Has its time come? Anal Bioanal Chem 2013; doi: 10.007/s 00216-013-7542-5.
29. Koivula MK, Matinlassi N, Laitinen P, Risteli J. Four automated 25-OH total vitamin D immunoassays and commercial liquid chromatography tandem-mass spectrometry in Finnish population. Clin Lab 2013;59: 397-405.
30. Kleerekoper M, Schleicher RL, Eisman J, Bouillon R, Singh RJ, Holick MF. Clinical applications for vitamin D assays: What is known and what is wished for. Clin Chem 2011;57: 1227-32.
31. Farrell CJ, 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.
32. Romagnoli E, Pepe J, Piemonte S, Cipriani C, Minisola S. Management of endocrine disease: Value and limitations of assessing vitamin D nutritional status and advised levels of vitamin D supplementation. Eur J Endocrinol 2013;169: R59-69.
33. Phinney KW. Development of a standard reference material for vitamin D in serum. Am J Clin Nutr 2008;88: 511S-2S.
34. 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.
35. Hollis BW. Measuring 25-hydroxyvitamin D in a clinical environment: Challenges and needs. Am J Clin Nutr 2008;88: 507S-10S.
36. Hollis BW. Assessment of vitamin D status and definition of a normal circulating range of 25-hydroxyvitamin D. Curr Opin in Endocrinol Diabetes Obes 2008;15: 489-94.
37. Carter GD, Berry JL, Gunter E, et al. Proficiency testing of 25-hydroxyvitamin D (25-OHD) assays. J Steroid Biochem Mol Biol 2010;121: 176-9.