Towards harmonization of directly measured free 25-hydroxyvitamin D using an enzyme-linked immunosorbent assay.

Tytuł:: Towards harmonization of directly measured free 25-hydroxyvitamin D using an enzyme-linked immunosorbent assay.
Autorzy:: Sempos CT; Office of Dietary Supplements, National Institutes of Health, Bethesda, MD, 20892, USA.; Vitamin D Standardization Program, LLC, Havre de Grace, MD, 21078, USA.
Lindhout E; Future Diagnostics, Nieuweweg 279, 6603 BN, Wijchen, Netherlands.
Heureux N; DIAsource Immunoassays, B-1348, Louvain-La-Neuve, Belgium.; BioSweet srl, B-5030, Lonzee, Belgium.
Hars M; DIAsource Immunoassays, B-1348, Louvain-La-Neuve, Belgium.
Parkington DA; Nutritional Biomarker Laboratory, MRC Epidemiology Unit, University of Cambridge, Cambridge, CB2 0AH, UK.
Dennison E; Immuno-Biological Laboratories Inc (IBL-America), Minneapolis, MN, 55432, USA.
Durazo-Arvizu R; The Saban Research Institute, Children's Hospital Los Angeles, Los Angeles, CA, 90027, USA.
Jones KS; Nutritional Biomarker Laboratory, MRC Epidemiology Unit, University of Cambridge, Cambridge, CB2 0AH, UK. .
Wise SA; Office of Dietary Supplements, National Institutes of Health, Bethesda, MD, 20892, USA.
Źródło:: Analytical and bioanalytical chemistry [Anal Bioanal Chem] 2022 Nov; Vol. 414 (27), pp. 7793-7803. Date of Electronic Publication: 2022 Sep 16.
Typ publikacji:: Journal Article
Język:: English
Imprint Name(s):: Original Publication: Heidelberg : Springer-Verlag, 2002-
MeSH Terms:: Vitamin D*/analogs & derivatives
Vitamin D*/metabolism
Vitamin D-Binding Protein*/metabolism
25-Hydroxyvitamin D 2 ; Calcifediol ; Enzyme-Linked Immunosorbent Assay ; Female ; Humans ; Pregnancy ; Vitamins
References:: Alexandridou A, Schorr P, Stokes CS, Volmer DA. Analysis of vitamin D metabolic markers by mass spectrometry: recent progress regarding the "gold standard" method and integration into clinical practice. Mass Spectrom Rev. 2021;1–41.
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(2):231–47. (PMID: 31907366)
Makris K, Sempos C, Cavalier E. The measurement of vitamin D metabolites: part I-metabolism of vitamin D and the measurement of 25-hydroxyvitamin D. Horm-Int J Endocrinol Metab. 2020;19(2):81–96.
Makris K, Sempos C, Cavalier E. The measurement of vitamin D metabolites part II-the measurement of the various vitamin D metabolites. Horm-Int J Endocrinol Metab. 2020;19(2):97–107.
Sempos CT, Binkley N. 25-Hydroxvitamin D assay standardization and vitamin D guidelines paralysis. Public Health Nutr. 2020;23(7):1153–64. (PMID: 323016887167380)
Wise SA, Camara JE, Sempos CT, Burdette CQ, Hahm G, Nalin F, et al. Interlaboratory comparison of 25-hydroxyvitamin D assays: Vitamin D Standardization Program (VDSP) intercomparison study 2 – part 1 liquid chromatography – tandem mass spectrometry (LC-MS/MS) assays – impact of 3-epi-25-hydroxyvitamin D3 on assay performance. Anal Bioanal Chem. 2022;414:333–49. (PMID: 34432104)
Wise SA, Camara JE, Sempos CT, Burdette CQ, Hahm G, Nalin F, et al. Interlaboratory comparison of 25-hydroxyvitamin D assays: Vitamin D Standardization Program (VDSP) intercomparison study 2 - part 2 ligand binding assays – impact of 25-hydroxyvitamin D 2 and 24R,25-dihydroxyvitamin D 3 on assay performance. Anal Bioanal Chem. 2022;414:351–66. (PMID: 34435207)
Wise SA, Camara JE, Sempos CT, Lukas P, Le Goff C, Peeters S, et al. Vitamin D Standardization Program (VDSP) Intralaboratory study for the assessment of 25-hydroxyvitamin D assay performance. J Steroid Biochem Mol Biol. 2021;212: 105917. (PMID: 340106878403635)
Elsenberg E, ten Boekel E, Huijgen H, Heijboer AC. Standardization of automated 25-hydroxyvitamin D assays: how successful is it? Clin Biochem. 2017;50(18):1126–30. (PMID: 28668468)
Garnett E, Li JL, Rajapakshe D, Tam E, Meng QH, Devaraj S. Efficacy of two vitamin D immunoassays to detect 25-OH vitamin D 2 and D 3 . Pract Lab Med. 2019;17:4.
Bjerg LN, Halgreen JR, Hansen SH, Morris HA, Jorgensen NR. An evaluation of total 25-hydroxyvitamin D assay standardization: where are we today? J Steroid Biochem Mol Biol. 2019;190:224–33. (PMID: 30940597)
Bikle DD, Malmstroem S, Schwartz J. Current controversies are free vitamin metabolite levels a more accurate assessment of vitamin d status than total levels? Endocrinol Metabol Clin North Amer. 2017;46(4):901–18.
Heureux N. Vitamin D testing-where are we and what is on the horizon? In: Makowski GS, editor. Advances in Clinical Chemistry, Vol 78. Advances in Clinical Chemistry. 78. San Diego: Elsevier Academic Press Inc. 2017; p. 59–101.
Tsuprykov O, Buse C, Skoblo R, Hocher B. Comparison of free and total 25-hydroxyvitamin D in normal human pregnancy. J Steroid Biochem Mol Biol. 2019;190:29–36. (PMID: 30904637)
Bikle D, Bouillon R, Thadhani R, Schoenmakers I. Vitamin D metabolites in captivity? Should we measure free or total 25(OH)D to assess vitamin D status? J Steroid Biochem Mol Biol. 2017;173:105–16. (PMID: 280933539005158)
Tsuprykov O, Elitok S, Buse C, Chu C, Kramer BK, Hocher B. Opposite correlation of 25-hydroxy-vitamin D- and 1,25-dihydroxy-vitamin D-metabolites with gestational age, bone- and lipid-biomarkers in pregnant women. Sci Rep. 2021;11(1):10.
Bikle DD, Schwartz J. Vitamin D binding protein, total and free vitamin D levels in different physiological and pathophysiological conditions. Front Endocrinol. 2019;10:12.
Tsuprykov O, Chen X, Hocher CF, Skoblo R, Yin LH, Hocher B. Why should we measure free 25(OH) vitamin D? J Steroid Biochem Mol Biol. 2018;180:87–104. (PMID: 29217467)
Bikle DD, Gee E, Halloran B, Kowalski MA, Ryzen E, Haddad JG. Assessment of the free fraction of 25-hydroxyvitamin-D in serum and its regulation by albumin and the vitamin-D-binding protein. J Clin Endocrinol Metab. 1986;63(4):954–9. (PMID: 3745408)
Bikle DD, Halloran BP, Gee E, Ryzen E, Haddad JG. Free 25-hydroxyvitamin-D levels are normal in subjects with liver-disease and reduced total 25-hydroxyvitamin-D levels. J Clin Invest. 1986;78(3):748–52. (PMID: 3745436423667)
Heureux N, Lindhout E, Swinkels L. A direct assay for measuring free 25-hydroxyvitamin D. J AOAC Int. 2017;100(5):1318–22. (PMID: 28492143)
Wang DC, Yu SL, Zou YT, Zhang YY, Qiu L, Chen LM. Distribution of free 25OHD in elderly population based on LC-MS/MS. J Steroid Biochem Mol Biol. 2020;200:5.
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;72:32–40.
Wise SA, Tai SSC, Burdette CQ, Camara JE, Bedner M, Lippa KA, et al. Role of the National Institute of Standards and Technology (NIST) in support of the vitamin D initiative of the National Institutes of Health, Office of Dietary Supplements. J AOAC Int. 2017;100(5):1260–76. (PMID: 28863788)
Tai SSC, Bedner M, Phinney KW. Development of a candidate reference measurement procedure for the determination of 25-hydroxyvitamin D 3 and 25-hydroxyvitamin D 2 in human serum using isotope-dilution liquid chromatography-tandem mass spectrometry. Anal Chem. 2010;82(5):1942–8. (PMID: 201361282838390)
Tai SSC, Nelson MA. Candidate reference measurement procedure for the determination of (24R),25-dihydroxyvitamin D 3 in human serum using isotope-dilution liquid chromatography-tandem mass spectrometry. Anal Chem. 2015;87(15):7964–70. (PMID: 26171884)
Stepman HCM, Vanderroost A, Van Uytfanghe K, Thienpont LM. Candidate reference measurement procedures for serum 25-hydroxyvitamin D 3 and 25-hydroxyvitamin D 2 by using isotope-dilution liquid chromatography-tandem mass spectrometry. Clin Chem. 2011;57(3):441–8. (PMID: 21248072)
Mineva EM, Schleicher RL, Chaudhary-Webb M, Maw KL, Botelho JC, Vesper HW, 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. 2015;407(19):5615–24. (PMID: 259671494823009)
Phinney KW, Bedner M, Tai SSC, Vamathevan VV, Sander LC, Sharpless KE, et al. Development and certification of a Standard Reference Material for vitamin D metabolites in human serum. Anal Chem. 2012;84(2):956–62. (PMID: 22141317)
Phinney KW, Tai SSC, Bedner M, Camara JE, Chia RRC, Sander LC, et al. Development of an improved Standard Reference Material for vitamin D metabolites in human serum. Anal Chem. 2017;89(9):4907–13. (PMID: 283750025575745)
Tai SSC, Nelson MA, Bedner M, Lang BE, Phinney KW, Sander LC, et al. Development of Standard Reference Material (SRM) 2973 vitamin D metabolites in frozen human serum (high level). J AOAC Int. 2017;100(5):1294–303. (PMID: 28917261)
CDC. Vitamin D Standardization — Certification Program https://www.cdc.gov/labstandards/vdscp.html Centers for Disease Control and Prevention. Accessed 8 Sept 2022.
Erdman P, Palmer-Toy DE, Horowitz G, Hoofnagle A. Accuracy-based vitamin D survey six years of quality improvement guided by proficiency testing. Arch Pathol Lab Med. 2019;143(12):1531–8. (PMID: 31116045)
Carter GD, Berry J, Durazo-Arvizu R, Gunter E, Jones G, Jones J, et al. Hydroxyvitamin D assays: an historical perspective from DEQAS. J Steroid Biochem Mol Biol. 2018;177:30–5. (PMID: 28734989)
Burdette CQ, Camara JE, Nalin F, Pritchett J, Sander LC, Carter GD, et al. Establishing an accuracy basis for the Vitamin D External Quality Assessment Scheme (DEQAS). J AOAC Int. 2017;100(5):1277–87. (PMID: 28847346)
Boggs ASP, Kilpatrick LE, Burdette CQ, Tevis DS, Fultz ZA, Nelson MA, et al. Development of a pregnancy-specific reference material for thyroid biomarkers, vitamin D, and nutritional trace elements in serum. Clin Chem Lab Med. 2021;59(4):671–9. (PMID: 33098630)
Miller WG, Myers GL, Gantzer ML, Kahn SE, Schonbrunner ER, Thienpont LM, et al. Roadmap for harmonization of clinical laboratory measurement procedures. Clin Chem. 2011;57(8):1108–17.
Myers GL, Miller WG. Challenge to coordinate harmonization activities on an international level. Clin Chem. 2017;63(9):1429–30. (PMID: 28684553)
Myers GL, Miller WG. The roadmap for harmonization: status of the International Consortium for Harmonization of Clinical Laboratory Results. Clin Chem Lab Med. 2018;56(10):1667–72. (PMID: 29672262)
Thienpont LM, Van uytfanghe K, De Leenheer AP. Reference measurement systems in clinical chemistry. Clin Chim Acta. 2002;323(1–2):73–87. (PMID: 12135808)
Sempos C, Bouillon R, Billen J, Gross M, Whitake J, Carlson H, et al. Interlaboratory comparison study of Future Diagnostics kit for the direct measurement of free 25OHD. 22nd Vitamin D Workshop, Poster Session I, Board 44, Thursday May 30, 2019, New York.
Best CM, Pressman EK, Queenan RA, Cooper E, O’Brien KO. Longitudinal changes in serum vitamin D binding protein and free 25-hydroxyvitamin D in a multiracial cohort of pregnant adolescents. J Steroid Biochem Mol Biol. 2019;186:79–88. (PMID: 30278215)
Jones KS, Assar S, Prentice A, Schoenmakers I. Vitamin D expenditure is not altered in pregnancy and lactation despite changes in vitamin D metabolite concentrations. Sci Rep. 2016;6:26795. (PMID: 272221094879580)
Tsuprykov O, Buse C, Skoblo R, Hocher B. Free 25 (OH) vitamin D, but not total 25 (OH) vitamin D, is strongly correlated with gestational age and calcium in normal human pregnancy. J Bone Miner Res. 2017;32:S323.
Zhang JY, Lucey AJ, Horgan R, Kenny LC, Kiely M. Impact of pregnancy on vitamin D status: a longitudinal study. Br J Nutr. 2014;112(7):1081–7. (PMID: 25159824)
Durazo-Arvizu RA, Tian L, Brooks SPJ, Sarafin K, Cashman KD, Kiely M, et al. The Vitamin D Standardization Program (VDSP) manual for retrospective laboratory standardization of serum 25-hydroxyvitamin D data. J AOAC Int. 2017;100(5):1234–43. (PMID: 28718397)
Sempos CT, Betz JM, Camara JE, Carter GD, Cavalier E, Clarke MW, et al. General steps to standardize the laboratory measurement of serum total 25-hydroxyvitamin D. J AOAC Int. 2017;100(5):1230–3. (PMID: 28766476)
Wise SA. What if using certified reference materials (CRMs) was a requirement to publish in analytical/bioanalytical chemistry journals? Anal Bioanal Chem. 2022, in press.
Schoenmakers I, Fraser WD, Forbes A. Vitamin D and acute and severe illness - a mechanistic and pharmacokinetic perspective. Nutr Res Rev. 2021;1–16.
Contributed Indexing:: Keywords: Enzyme-linked immunosorbent assay (ELISA); Free 25-hydroxyvitamin D; Standard Reference Materials (SRMs); Total 25-hydroxyvitamin D; Vitamin D binding protein
Substance Nomenclature:: 0 (Vitamin D-Binding Protein)
0 (Vitamins)
1406-16-2 (Vitamin D)
21343-40-8 (25-Hydroxyvitamin D 2)
A288AR3C9H (25-hydroxyvitamin D)
P6YZ13C99Q (Calcifediol)
Entry Date(s):: Date Created: 20220915 Date Completed: 20221018 Latest Revision: 20221025
Update Code:: 20240105
PubMed Central ID:: PMC9568476
DOI:: 10.1007/s00216-022-04313-y
PMID:: 36109397
: Czasopismo naukowe

Pełny tekst

The majority of circulating 25-hydroxyvitamin D (25(OH)D) is protein bound and perhaps less available than the free fraction of 25(OH)D; therefore, researchers have proposed that the measurement of free 25(OH)D in human serum may be a better indicator of vitamin D health status than total 25(OH)D. The availability of a new enzyme-linked immunosorbent assay (ELISA) for the determination of free 25(OH)D provides a method for direct measurement of the low levels of non-protein bound 25(OH)D. As an initial step towards harmonization of measurements of free 25(OH)D, the ELISA was used to measure free 25(OH)D in three existing Standard Reference Materials (SRMs): SRM 972a Vitamin D Metabolites in Frozen Human Serum, SRM 2973 Vitamin D Metabolites in Frozen Human Serum (High Level), and SRM 1949 Frozen Prenatal Human Serum. Target values for free 25(OH)D in the nine SRM serum pools, obtained by combining the results from two laboratories, ranged from 3.76 ± 0.36 to 10.0 ± 0.58 pg/mL. Of particular significance is the assignment of free 25(OH)D target values to SRM 1949, which consists of four serum pools from non-pregnant female donors of reproductive age and pregnant women in each of the three trimesters and which also has values assigned for vitamin D binding protein, which increases during pregnancy. The availability of target values for free 25(OH)D in these SRMs will allow researchers to validate new analytical methods and to compare their results with other researchers as an initial step towards harmonization of measurements among different studies and laboratories.
(© 2022. The Author(s).)

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