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.
Wise, Stephen A.; Camara, Johanna E.; Burdette, Carolyn Q.et al.
24R,25-Dihydroxyvitamin D3 [24R,25(OH)2D3]; 25-Hydroxyvitamin D2 [25(OH)D2]; 25-Hydroxyvitamin D3 [25(OH)D3]; Ligand binding assay; Liquid chromatography–tandem mass spectrometry (LC-MS/MS); Total 25-hydroxyvitamin D [25(OH)D]
Abstract :
[en] An interlaboratory comparison study was conducted by the Vitamin D Standardization Program (VDSP) to assess the performance of ligand binding assays (Part 2) for the determination of serum total 25-hydroxyvitamin D [25(OH)D]. Fifty single-donor samples were assigned target values for concentrations of 25-hydroxyvitamin D(2) [25(OH)D(2)], 25-hydroxyvitamin D(3) [25(OH)D(3)], 3-epi-25-hydroxyvitamin D(3) [3-epi-25(OH)D(3)], and 24R,25-dihydroxyvitamin D(3) [24R,25(OH)(2)D(3)] using isotope dilution liquid chromatography-tandem mass spectrometry (ID LC-MS/MS). VDSP Intercomparison Study 2 Part 2 includes results from 17 laboratories using 32 ligand binding assays. Assay performance was evaluated using mean % bias compared to the assigned target values and using linear regression analysis of the test assay mean results and the target values. Only 50% of the ligand binding assays achieved the VDSP criterion of mean % bias ≤ |± 5%|. For the 13 unique ligand binding assays evaluated in this study, only 4 assays were consistently within ± 5% mean bias and 4 assays were consistently outside ± 5% mean bias regardless of the laboratory performing the assay. Based on multivariable regression analysis using the concentrations of individual vitamin D metabolites in the 50 single-donor samples, most assays underestimate 25(OH)D(2) and several assays (Abbott, bioMérieux, DiaSorin, IDS-EIA, and IDS-iSYS) may have cross-reactivity from 24R,25(OH)(2)D(3). The results of this interlaboratory study represent the most comprehensive comparison of 25(OH)D ligand binding assays published to date and is the only study to assess the impact of 24R,25(OH)(2)D(3) content using results from a reference measurement procedure.
Disciplines :
Laboratory medicine & medical technology
Author, co-author :
Wise, Stephen A.
Camara, Johanna E.
Burdette, Carolyn Q.
Hahm, Grace
Nalin, Federica
Kuszak, Adam J.
Merkel, Joyce
Durazo-Arvizu, Ramón A.
Williams, Emma L.
Popp, Christian
Beckert, Christian
Schultess, Jan
Van Slooten, Glen
Tourneur, Carole
Pease, Camille
Kaul, Ravi
Villarreal, Alfredo
Batista, Marcelo Cidade
Pham, Heather
Bennett, Alex
Jansen, Eugene
Khan, Dilshad Ahmed
Kilbane, Mark
Twomey, Patrick J.
Freeman, James
Parker, Neil
Mushtaq, Sohail
Simpson, Christine
LUKAS, Pierre ; Centre Hospitalier Universitaire de Liège - CHU > Unilab > Bone and cartilage markers laboratory
Cavalier, Etienne ; Université de Liège - ULiège > Département de pharmacie > Chimie médicale
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.
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. 10.3109/00365513.2012.681935. DOI: 10.3109/00365513.2012.681935
Binkley N, Dawson-Hughes B, Durazo-Arvizu R, Thamm M, Tian L, Merkel JM, et al. Vitamin D measurement standardization: the way out of the chaos. J Steroid Biochem Mol Biol. 2017;173:117–21. 10.1016/j.jsbmb.2016.12.002. DOI: 10.1016/j.jsbmb.2016.12.002
Binkley N, Krueger D, Cowgill CS, Plum L, Lake E, Hansen KE, et al. Assay variation confounds the diagnosis of hypovitaminosis D: a call for standardization. J Clin Endocrinol Metab. 2004;89(7):3152–7. 10.1210/jc.2003-031979. DOI: 10.1210/jc.2003-031979
Wise SA, Phinney KW, Tai SSC, Camara JE, Myers GL, Durazo-Arvizu R, et al. Baseline assessment of 25-hydroxyvitamin D assay performance: a Vitamin D Standardization Program (VDSP) interlaboratory comparison study. J AOAC Int. 2017;100(5):1244–52. 10.5740/jaoacint.17-0258. DOI: 10.5740/jaoacint.17-0258
Sempos CT, Binkley N. 25-Hydroxvitamin D assay standardization and vitamin D guidelines paralysis. Public Health Nutrition. 2020;23(7):1153–64. 10.1017/S1368980019005251. DOI: 10.1017/S1368980019005251
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. European Journal of Clinical Nutrition. 2020;74(2):231–47. 10.1038/s41430-019-0553-3. DOI: 10.1038/s41430-019-0553-3
Bivona G, Lo Sasso B, Iacolino G, Gambino CM, Scazzone C, Agnello L, et al. Standardized measurement of circulating vitamin D 25(OH)D and its putative role as a serum biomarker in Alzheimer’s disease and Parkinson’s disease. Clin Chim Acta. 2019;497:82–7. 10.1016/j.cca.2019.07.022. DOI: 10.1016/j.cca.2019.07.022
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. 10.1016/j.jsbmb.2019.03.015. DOI: 10.1016/j.jsbmb.2019.03.015
Fraser WD, Tang JCY, Dutton JJ, Schoenmakers I. Vitamin D measurement, the debates continue, new analytes have emerged, developments have variable outcomes. Calcified Tissue International. 2020;106(1):3–13. 10.1007/s00223-019-00620-2. DOI: 10.1007/s00223-019-00620-2
Herrmann M, Farrell CJL, Pusceddu I, Fabregat-Cabello N, Cavalier E. Assessment of vitamin D status - a changing landscape. Clin Chem Lab Med. 2017;55(1):3–26. 10.1515/cclm-2016-0264. DOI: 10.1515/cclm-2016-0264
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. 10.1007/s42000-019-00169-7. DOI: 10.1007/s42000-019-00169-7
Stokes CS, Lammert F, Volmer DA. Analytical methods for quantification of vitamin D and implications for research and clinical practice. Anticancer Res. 2018;38(2):1137–44. 10.21873/anticanres.12332. DOI: 10.21873/anticanres.12332
Wise SA, Camara JE, Sempos CT, Burdette CQ, Hahm G, Nalin F, et al. (2022) 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, doi: 10.1007/s00216-021-3576-1 DOI: 10.1007/s00216-021-3576-1
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. 10.1021/ac202047n. DOI: 10.1021/ac202047n
Phinney KW, Sempos CT, Tai SSC, Camara JE, Wise SA, Eckfeldt JH, et al. Baseline assessment of 25-hydroxyvitamin D reference material and proficiency testing/external quality assurance material commutability: a Vitamin D Standardization Program Study. J AOAC Int. 2017;100(5):1288–93. 10.5740/jaoacint.17-0291. DOI: 10.5740/jaoacint.17-0291
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. 10.5740/jaoacint.17-0182. DOI: 10.5740/jaoacint.17-0182
Binkley N, Sempos CT, VDSP. Standardizing vitamin D assays: the way forward. J Bone Miner Res. 2014;29(8):1709–14. 10.1002/jbmr.2252. DOI: 10.1002/jbmr.2252
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(1-2):8–13. 10.1016/j.cca.2009.06.027. DOI: 10.1016/j.cca.2009.06.027
Depreter B, Heijboer AC, Langlois MR. Accuracy of three automated 25-hydroxyvitamin D assays in hemodialysis patients. Clin Chim Acta. 2013;415:255–60. 10.1016/j.cca.2012.10.056. DOI: 10.1016/j.cca.2012.10.056
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(3):543–8. 10.1373/clinchem.2011.176545. DOI: 10.1373/clinchem.2011.176545
Cavalier E, Lukas P, Bekaert AC, Carlisi A, Le Goff C, Delanaye P, et al. Analytical and clinical validation of the new Abbot Architect 25(OH) D assay: fit for purpose? Clin Chem Lab Med. 2017;55(3):378–84. 10.1515/cclm-2016-0566. DOI: 10.1515/cclm-2016-0566
Cavalier E, Lukas P, Bekaert AC, Peeters S, Le Goff C, Yayo E, et al. Analytical and clinical evaluation of the new Fujirebio Lumipulse (R) G non-competitive assay for 25(OH)-vitamin D and three immunoassays for 25(OH) D in healthy subjects, osteoporotic patients, third trimester pregnant women, healthy African subjects, hemodialyzed and intensive care patients. Clin Chem Lab Med. 2016;54(8):1347–55. 10.1515/cclm-2015-0923. DOI: 10.1515/cclm-2015-0923
Cavalier E, Lukas P, Crine Y, Peeters S, Carlisi A, Le Goff C, et al. Evaluation of automated immunoassays for 25(OH)-vitamin D determination in different critical populations before and after standardization of the assays. Clin Chim Acta. 2014;431:60–5. 10.1016/j.cca.2014.01.026. DOI: 10.1016/j.cca.2014.01.026
Cavalier E, Rousselle O, Ferrante N, Carlisi A, Le Goff C, Souberbielle JC. Technical and clinical evaluation of the VITROS (R) Immunodiagnostic Products 25-OH Vitamin D Total Assay - comparison with marketed automated immunoassays and a liquid chromatography-tandem mass spectrometry method. Clin Chem Lab Med. 2013;51(10):1983–9. 10.1515/cclm-2013-0138. DOI: 10.1515/cclm-2013-0138
Moreau E, Bacher S, Mery S, Le Goff C, Piga N, Vogeser M, et al. Performance characteristics of the VIDAS (R) 25-OH Vitamin D Total assay - comparison with four immunoassays and two liquid chromatography-tandem mass spectrometry methods in a multicentric study. Clin Chem Lab Med. 2016;54(1):45–53. 10.1515/cclm-2014-1249. DOI: 10.1515/cclm-2014-1249
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. 10.1016/j.clinbiochem.2017.06.011. DOI: 10.1016/j.clinbiochem.2017.06.011
Hutchinson K, Healy M, Crowley V, Loew M. Verification of Abbott 25-(OH)-vitamin D assay on the architect system. Practical Laboratory Medicine. 2017;7:27–35. 10.1016/j.plabm.2017.01.001. DOI: 10.1016/j.plabm.2017.01.001
Annema W, Nowak A, von Eckardstein A, Saleh L. Evaluation of the new restandardized Abbott Architect 25-OH Vitamin D assay in vitamin D-insufficient and vitamin D-supplemented individuals. J Clin Lab Anal. 2018;32(4). 10.1002/jcla.22328.
Garnett E, Li J, Rajapakshe D, Tam E, Meng QH, Devaraj S. Efficacy of two vitamin D immunoassays to detect 25-OH vitamin D2 and D3. Practical Laboratory Medicine. 2019;17:e00130. 10.1016/j.plabm.2019.e00130. DOI: 10.1016/j.plabm.2019.e00130
Lim YK, Park AJ, Kweon OJ, Choi JH. Performance evaluation and measurement uncertainty determination of the new version of the Abbott Architect 25-OH Vitamin D 5P02 Assay. Am J Clin Pathol. 2019;151(2):209–16. 10.1093/ajcp/aqy131. DOI: 10.1093/ajcp/aqy131
Camara J, Hoofnagle A, Carter G, Sempos C (2015) Take two: gearing up for the next vitamin D commutability study. Clinical Laboratory News (February 1, 2015)
Tai SSC, Bedner M, Phinney KW. 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. 2010;82(5):1942–8. 10.1021/ac9026862. DOI: 10.1021/ac9026862
Tai SSC, Nelson MA. 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. 2015;87(15):7964–70. 10.1021/acs.analchem.5b01861. DOI: 10.1021/acs.analchem.5b01861
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. 10.1016/j.jsbmb.2021.105917. DOI: 10.1016/j.jsbmb.2021.105917
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. 10.1016/j.jsbmb.2017.07.018. DOI: 10.1016/j.jsbmb.2017.07.018
Schleicher RL, Sternberg MR, Lacher DA, Sempos CT, Looker AC, Durazo-Arvizu RA, 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. 2016;104(2):454–61. 10.3945/ajcn.115.127985. DOI: 10.3945/ajcn.115.127985
Schleicher RL, Sternberg MR, Looker AC, Yetley EA, Lacher DA, Sempos CT, et al. National estimates of serum total 25-hydroxyvitamin D and metabolite concentrations measured by liquid chromatography-tandem mass spectrometry in the US population during 2007-2010. J Nutr. 2016;146(5):1051–61. 10.3945/jn.115.227728. DOI: 10.3945/jn.115.227728
Cavalier E, Wallace AM, Carlisi A, Chapelle JP, Delanaye P, Souberbielle JC. Cross-reactivity of 25-hydroxy vitamin D2 from different commercial immunoassays for 25-hydroxy vitamin D: an evaluation without spiked samples. Clin Chem Lab Med. 2011;49(3):555–8. 10.1515/cclm.2011.072. DOI: 10.1515/cclm.2011.072
Cashman KD, Hayes A, Galvin K, Merkel J, Jones G, Kaufmann M, et al. Significance of serum 24,25-dihydroxyvitamin D in the assessment of vitamin D status: a double-edged sword? Clin Chem. 2015;61(4):636–45. 10.1373/clinchem.2014.234955. DOI: 10.1373/clinchem.2014.234955
Wyness SP, Straseski JA. Performance characteristics of six automated 25-hydroxyvitamin D assays: mind your 3s and 2s. Clin Biochem. 2015;48(16-17):1089–96. 10.1016/j.clinbiochem.2015.08.005. DOI: 10.1016/j.clinbiochem.2015.08.005
Black LJ, Anderson D, Clarke MW, Ponsonby AL, Lucas RM, Ausimmune Investigator G. Analytical bias in the measurement of serum 25-hydroxyvitamin D concentrations impairs assessment of vitamin D status in clinical and research settings. PLoS One. 2015;10(8). 10.1371/journal.pone.0135478.
de Koning L, Al-Turkmani MR, Berg AH, Shkreta A, Law T, Kellogg MD. Variation in clinical vitamin D status by DiaSorin Liaison and LC-MS/MS in the presence of elevated 25-OH vitamin D-2. Clin Chim Acta. 2013;415:54–8. 10.1016/j.cca.2012.09.002. DOI: 10.1016/j.cca.2012.09.002
Stepman HCM, Vanderroost A, Van Uytfanghe K, Thienpont LM. Candidate reference measurement procedures for serum 25-hydroxyvitamin D3 and 25-hydroxyvitamin D2 by using isotope-dilution liquid chromatography-tandem mass spectrometry. Clin Chem. 2011;57(3):441–8. 10.1373/clinchem.2010.152553. DOI: 10.1373/clinchem.2010.152553
Denimal D, Roux S, Duvillard L. Evaluation of the new restandardized 25-hydroxyvitamin D assay on the iSYS platform. Clin Biochem. 2018;52:156–60. 10.1016/j.clinbiochem.2017.11.011. DOI: 10.1016/j.clinbiochem.2017.11.011
