Vitamin D Standardization Program (VDSP) Intralaboratory Study for the Assessment of 25-Hydroxyvitamin D Assay Variability and Bias.

Wise, Stephen A.; Camara, Johanna E.; Sempos, Christopher T.; LUKAS, Pierre; Le Goff, Caroline; PEETERS, Stéphanie; Burdette, Carolyn Q.; Nalin, Federica; Hahm, Grace; Durazo-Arvizu, Ramón A.; Kuszak, Adam J.; Merkel, Joyce; Cavalier, Etienne

doi:10.1016/j.jsbmb.2021.105917

Article (Scientific journals)

Vitamin D Standardization Program (VDSP) Intralaboratory Study for the Assessment of 25-Hydroxyvitamin D Assay Variability and Bias.

Wise, Stephen A.; Camara, Johanna E.; Sempos, Christopher T. et al.

2021 • In The Journal of steroid biochemistry and molecular biology, 212, p. 105917

Peer reviewed

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https://hdl.handle.net/2268/262281

DOI
10.1016/j.jsbmb.2021.105917

PubMed
34010687

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Keywords :

25-hydroxyvitamin D(2); 25-hydroxyvitamin D(3); 3-epi-25hydroxyvitamin D(3); Vitamin D Standardization Program (VDSP); immunoassay; liquid chromatography – tandem mass spectrometry (LCMS/MS); reference measurement procedure (RMP); serum total 25-hydroxyvitamin D

Abstract :

[en] An intralaboratory study assessing assay variability and bias for determination of serum total 25-hydroxyvitamin D [25(OH)D] was conducted by the Vitamin D Standardization Program (VDSP). Thirteen assays for serum total 25(OH)D were evaluated in a single laboratory including 11 unique immunoassays and one liquid chromatography - tandem mass spectrometry (LC-MS/MS) assay. Fifty single-donor serum samples, including eight samples with high concentrations of 25(OH)D(2) (> 30 nmol/L), were assigned target values for 25(OH)D(2) and 25(OH)D(3) using reference measurement procedures (RMP). Using four replicate measurements for each sample, the mean total percent coefficient of variation (%CV) and mean % bias from the target values were determined for each assay using the 50 single-donor samples and a 42-sample subset, which excluded 8 high 25(OH)D(2) concentration samples, and compared with VDSP performance criteria of ≤ 10% CV and ≤ ±5% mean bias. All 12 assays achieved the performance criterion for %CV, and 9 of the 12 assays were within ≤ ±5 % mean bias. The Fujirebio Inc. assay exhibited the lowest %CV and highest percentage of individual measurements within ≤ ±5% mean bias. Ten immunoassays exhibited changes in response due to the high 25(OH)D(2) samples with Abbott, Biomérieux, DiaSorin, DIAsource, and IDS-iSYS assays having the largest deviations. The Fujirebio Inc. and Beckman Coulter assays were only minimally affected by the presence of the high 25(OH)D(2) samples. Samples with high concentrations of 25(OH)D(2) provided a critical performance test for immunoassays indicating that some assays may not have equal response or recovery for 25(OH)D(2) and 25(OH)D(3).

Disciplines :

Laboratory medicine & medical technology

Author, co-author :

Wise, Stephen A.

Camara, Johanna E.

Sempos, Christopher T.

LUKAS, Pierre ; Centre Hospitalier Universitaire de Liège - CHU > Unilab > Bone and cartilage markers laboratory

Le Goff, Caroline ; Université de Liège - ULiège > Département des sciences de la santé publique > Département des sciences de la santé publique

PEETERS, Stéphanie ; Centre Hospitalier Universitaire de Liège - CHU > Unilab > Laboratoire techniques séparatives et stress oxydant

Burdette, Carolyn Q.

Nalin, Federica

Hahm, Grace

Durazo-Arvizu, Ramón A.

More authors (3 more)

Language :

English

Title :

Vitamin D Standardization Program (VDSP) Intralaboratory Study for the Assessment of 25-Hydroxyvitamin D Assay Variability and Bias.

Publication date :

September 2021

Journal title :

The Journal of steroid biochemistry and molecular biology

ISSN :

0960-0760

eISSN :

1879-1220

Volume :

212

Pages :

105917

Peer reviewed :

Peer reviewed

Commentary :

Available on ORBi :

since 26 July 2021

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Bibliography

Binkley, N., Dawson-Hughes, B., Durazo-Arvizu, R., Thamm, M., Tian, L., Merkel, J.M., Jones, J.C., Carter, G.D., Sempos, C.T., Vitamin D measurement standardization: the way out of the chaos. J. Steroid Biochem. Mol. Biol. 173 (2017), 117–121.
Binkley, N., Krueger, D., Cowgill, C.S., Plum, L., Lake, E., Hansen, K.E., DeLuca, H.F., Drezner, M.K., Assay variation confounds the diagnosis of hypovitaminosis D: a call for standardization. J. Clin. Endocrinol. Metab. 89 (2004), 3152–3157.
Wise, S.A., Phinney, K.W., Tai, S.S.C., Camara, J.E., Myers, G.L., Durazo-Arvizu, R., Tian, L., Hoofnagle, A.N., Bachmann, L.M., Young, I.S., Pettit, J., Caldwell, G., Liu, A., Brooks, S.P.J., Sarafin, K., Thamm, M., Mensink, G.B.M., Busch, M., Rabenberg, M., Cashman, K.D., Kiely, M., Kinsella, M., Galvin, K., Zhang, J.Y., Oh, K., Lee, S.W., Jung, C.L., Cox, L., Goldberg, G., Guberg, K., Prentice, A., Carter, G.D., Jones, J., Brannon, P.M., Lucas, R.M., Crump, P.M., Cavalier, E., Merkel, J., Betz, J.M., Sempos, C.T., Baseline assessment of 25-hydroxyvitamin D assay performance: a Vitamin D Standardization Program (VDSP) interlaboratory comparison study. J. AOAC Int. 100 (2017), 1244–1252.
Sempos, C.T., Binkley, N., 25-Hydroxvitamin D assay standardization and vitamin D guidelines paralysis. Public Health Nutr. 23 (2020), 1153–1164.
Sempos, C.T., Heijboer, A.C., Bikle, D.D., Bollerslev, J., Bouillon, R., Brannon, P.M., DeLuca, H.F., Jones, G., Munns, C.F., Bilezikian, J.P., Giustina, A., Binkley, N., Vitamin D assays and the definition of hypovitaminosis D: results from the First International Conference on Controversies in Vitamin D. Br. J. Clin. Pharmacol. 84 (2018), 2194–2207.
Altieri, B., Cavalier, E., Bhattoa, H.P., Perez-Lopez, F.R., Lopez-Baena, M.T., Perez-Roncero, G.R., Chedraui, P., Annweiler, C., Della Casa, S., Zelzer, S., Herrmann, M., Faggiano, A., Colao, A., Holick, M.F., Vitamin D testing: advantages and limits of the current assays. Eur. J. Clin. Nutr. 74 (2020), 231–247.
Bivona, G., Lo Sasso, B., Iacolino, G., Gambino, C.M., Scazzone, C., Agnello, L., Ciaccio, M., 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 497 (2019), 82–87.
Bjerg, L.N., Halgreen, J.R., Hansen, S.H., Morris, H.A., Jorgensen, N.R., An evaluation of total 25-hydroxyvitamin D assay standardization: where are we today?. J. Steroid Biochem. Mol. Biol. 190 (2019), 224–233.
Dirks, N.F., Martens, F., Vanderschueren, D., Billen, J., Pauwels, S., Ackermans, M.T., Endert, E., den Heijer, M., Blankenstein, M.A., Heijboer, A.C., Determination of human reference values for serum total 1,25-dihydroxyvitamin D using an extensively validated 2D ID-UPLC–MS/MS method. J. Steroid Biochem. Mol. Biol. 164 (2016), 127–133.
Fraser, W.D., Tang, J.C.Y., Dutton, J.J., Schoenmakers, I., Vitamin D measurement, the debates continue, new analytes have emerged, developments have variable outcomes. Calcif. Tissue Int. 106 (2020), 3–13.
Herrmann, M., Farrell, C.J.L., Pusceddu, I., Fabregat-Cabello, N., Cavalier, E., Assessment of vitamin D status - a changing landscape. Clin. Chem. Lab. Med. 55 (2017), 3–26.
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. 19 (2020), 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. 19 (2020), 97–107.
Stokes, C.S., Lammert, F., Volmer, D.A., Analytical methods for quantification of vitamin D and implications for research and clinical practice. Anticancer Res. 38 (2018), 1137–1144.
Wise, S.A., Tai, S.S.C., Burdette, C.Q., Camara, J.E., Bedner, M., Lippa, K.A., Nelson, M.A., Nalin, F., Phinney, K.W., Sander, L.C., Betz, J.M., Sempos, C.T., Coates, P.M., 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. 100 (2017), 1260–1276.
Sempos, C.T., Vesper, H.W., Phinney, K.W., Thienpont, L.M., Coates, P.M., Vdsp, Vitamin D status as an international issue: national surveys and the problem of standardization. Scand. J. Clin. Lab. Invest. 72 (2012), 32–40.
Tai, S.S.C., Bedner, M., Phinney, K.W., 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. 82 (2010), 1942–1948.
Stepman, H.C.M., Vanderroost, A., Van Uytfanghe, K., Thienpont, L.M., 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. 57 (2011), 441–448.
Mineva, E.M., Schleicher, R.L., Chaudhary-Webb, M., Maw, K.L., Botelho, J.C., Vesper, H.W., Pfeiffer, C.M., 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 (2015), 5615–5624.
Phinney, K.W., Bedner, M., Tai, S.S.C., Vamathevan, V.V., Sander, L.C., Sharpless, K.E., Wise, S.A., Yen, J.H., Schleicher, R.L., Chaudhary-Webb, M., Pfeiffer, C.M., Betz, J.M., Coates, P.M., Picciano, M.F., Development and certification of a Standard Reference Material for vitamin D metabolites in human serum. Anal. Chem. 84 (2012), 956–962.
Phinney, K.W., Tai, S.S.C., Bedner, M., Camara, J.E., Chia, R.R.C., Sander, L.C., Sharpless, K.E., Wise, S.A., Yen, J.H., Schleicher, R.L., Chaudhary-Webb, M., Maw, K.L., Rahmani, Y., Betz, J.M., Merkel, J., Sempos, C.T., Coates, P.M., Durazo-Arvizu, R.A., Sarafin, K., Brooks, S.P.J., Development of an improved Standard Reference Material for vitamin D metabolites in human serum. Anal. Chem. 89 (2017), 4907–4913.
Tai, S.S.C., Nelson, M.A., Bedner, M., Lang, B.E., Phinney, K.W., Sander, L.C., Yen, J.H., Betz, J.M., Sempos, C.T., Wise, S.A., Development of standard reference material (SRM) 2973. Vitamin D Metabolites in Frozen Human Serum (High Level), J. AOAC Int. 100 (2017), 1294–1303.
CDC, Vitamin D Standardization — Certification Program https://www.cdc.gov/labstandards/vdscp.html, Centers for Disease Control and Prevention.
Erdman, P., Palmer-Toy, D.E., Horowitz, G., Hoofnagle, A., Accuracy-based vitamin D survey six years of quality improvement guided by proficiency testing. Arch. Pathol. Lab. Med. 143 (2019), 1531–1538.
Burdette, C.Q., Camara, J.E., Nalin, F., Pritchett, J., Sander, L.C., Carter, G.D., Jones, J., Betz, J.M., Sempos, C.T., Wise, S.A., Establishing an accuracy basis for the vitamin d external quality assessment scheme (DEQAS). J. AOAC Int. 100 (2017), 1277–1287.
Carter, G.D., Berry, J., Durazo-Arvizu, R., Gunter, E., Jones, G., Jones, J., Makin, H.L.J., Pattni, P., Sempos, C.T., Twomey, P., Williams, E.L., Wise, S.A., Hydroxyvitamin d assays: an historical perspective from DEQAS. J. Steroid Biochem. Mol. Biol. 177 (2018), 30–35.
DEQAS, Vitamin D External Quality Assessment Scheme (DEQAS); www.deqas.org.
Binkley, N., Sempos, C.T., Vitamin, D.S.P., Standardizing vitamin D assays: the way forward. J. Bone Miner. Res. 29 (2014), 1709–1714.
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 (2009), 8–13.
Phinney, K.W., Sempos, C.T., Tai, S.S.C., Camara, J.E., Wise, S.A., Eckfeldt, J.H., Hoofnagle, A.N., Carter, G.D., Jones, J., Myers, G.L., Durazo-Arvizu, R., Miller, W.G., Bachmann, L.M., Young, I.S., Pettit, J., Caldwell, G., Liu, A., Brooks, S.P.J., Sarafin, K., Thamm, M., Mensink, G.S.M., Busch, M., Rabenberg, M., Cashman, K.D., Kiely, M., Galvin, K., Zhang, J.Y., Kinsella, M., Oh, K., Lee, S.W., Jung, C.L., Cox, L., Goldberg, G., Guberg, K., Meadows, S., Prentice, A., 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. 100 (2017), 1288–1293.
Wise, S.A., Camara, J.E., Sempos, C.T., Burdette, C.Q., Hahm, G., Nalin, F., Kuszak, A.J., Merkel, J., Durazo-Arvizu, R., Hoofnagle, A.N., Williams, E.L., Ivison, F., Fischer, R., Van den Ouweland, J.M.W., Ho, C.S., Law, E.W.K., Simard, J.-N., Gonthier, R., Holmquist, B., Meadows, S., Cox, L., Robyak, K., Creer, M.H., Fitzgerald, R., Clarke, M.W., Breen, N., Lukas, P., Cavalier, E., 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, to be submitted to anal. Anal. Bioanal. Chem., 2021 submitted to.
Wise, S.A., Camara, J.E., Sempos, C.T., Burdette, C.Q., Hahm, G., Nalin, F., Kuszak, A.J., Merkel, J., Durazo-Arvizu, R., Williams, E.L., Popp, C., Beckert, C., Schultess, C., Van Slooten, G., Tourneur, C., Pease, C., Kaul, R., Villarreal, A., Batista, M.C., Pham, H., Bennett, A., Jansen, E., Khan, D.A., Kilbane, M., Freeman, J., Parker, N., Yuan, J., Mushtaq, S., Simpson, C., Lukas, P., Cavalier, E., Interlaboratory comparison of 25-Hydroxyvitamin d assays: vitamin d standardization program (VDSP) intercomparison study 2 - part 2 immunoassays – impact of 25-Hydroxyvitamin D2 and 24R,25-Dihydroxyvitamin D3 on assay performance. Anal. Bioanal. Chem., 2021 submitted to.
Camara, J.E., Wise, S.A., Hoofnagle, A.N., Williams, E.L., Carter, G.D., Jones, J., Burdette, C.Q., Hahm, G., Nalin, F., Kuszak, A.J., Cavalier, E., Lukas, P., Durazo-Arvizu, R., Popp, C., Beckert, C., Schultess, C., Van Slooten, G., Tourneur, C., Pease, C., Kaul, K., Villarreal, A., Emanuelli, B., Maggio, A., Ivison, F., Fischer, R., van den Ouweland, J.M.W., Ho, C.S., Law, E.W.K., Simard, J.-N., Gonthier, R., Holmquist, B., Batista, M.C., Pham, H., Bennett, A., Meadows, S., Cox, L., Jansen, E., Khan, D.A., Robyak, K., Creer, M.H., Kilbane, M., Freeman, J., Parker, N., Chen, V., Fitzgerald, R., Mushtaq, S., Clarke, M.W., Breen, N., Simpson, C., Sempos, C.T., Assessment of serum total 25-hydroxyvitamin d assay commutability of standard reference materials, college of American Pathologists Accuracy-Based vitamin d (ABVD) scheme and vitamin d external quality assessment scheme (DEQAS) materials: vitamin D Standardization Program (VDSP) commutability study 2. Anal. Bioanal. Chem., 2021 in press.
CLSI, Preparation and Validation of Commutable Frozen Human Serum Pools As Secondary Reference Materials for Cholesterol Measurement Procedures, CLSI Document C37-A. 1999, Clinical and Laboratory Standards Institute, Wayne, PA.
Danilenko, U., Vesper, H.W., Myers, G.L., Clapshaw, P.A., Camara, J.E., Miller, W.G., An updated protocol based on CLSI document C37 for preparation of off-the-clot serum from individual units for use alone or to prepare commutable pooled serum reference materials. Clin. Chem. Lab. Med. 58 (2020), 368–374.
Fabregat-Cabello, N., Farre-Segura, J., Huyghebaert, L., Peeters, S., Le Goff, C., Souberbielle, J.C., Cavalier, E., A fast and simple method for simultaneous measurements of 25(OH)D, 24, 25(OH)(2)D and the Vitamin D Metabolite Ratio (VMR) in serum samples by LC–MS/MS. Clin. Chim. Acta 473 (2017), 116–123.
Cavalier, E., Wallace, A.M., Carlisi, A., Chapelle, J.P., Delanaye, P., Souberbielle, J.C., 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. 49 (2011), 555–558.
Schleicher, R.L., Sternberg, M.R., Lacher, D.A., Sempos, C.T., Looker, A.C., Durazo-Arvizu, R.A., Yetley, E.A., Chaudhary-Webb, M., Maw, K.L., Pfeiffer, C.M., Johnson, C.L., 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 (2016), 454–461.
Schleicher, R.L., Sternberg, M.R., Looker, A.C., Yetley, E.A., Lacher, D.A., Sempos, C.T., Taylor, C.L., Durazo-Arvizu, R.A., Maw, K.L., Chaudhary-Webb, M., Johnson, C.L., Pfeiffer, C.M., 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. 146 (2016), 1051–1061.
CLSI, Measurement Procedure Comparison and Bias Estimation Using Patient Samples,. CSLI Document EP09c. 2018, Clinical and Laboratory Standards Institute, Wayne, PA.
Freeman, J., Wilson, K., Spears, R., Shalhoub, V., Sibley, P., Performance evaluation of four 25-hydroxyvitamin D assays to measure 25-hydroxyvitamin D-2. Clin. Biochem. 48 (2015), 1097–1104.
Garnett, E., Li, J.L., Rajapakshe, D., Tam, E., Meng, Q.H., Devaraj, S., Efficacy of two vitamin D immunoassays to detect 25-OH vitamin D2 and D3. Pract. Lab. Med., 17, 2019, 4.