Baseline assessment of 25-hydroxyVitamin D assay performance: A Vitamin D standardization program (VDSP) interlaboratory comparison study

Stephen A. Wise; Karen W. Phinney; Susan S.C. Tai; Johanna E. Camara; Gary L. Myers; Ramon Durazo-Arvizu; Lu Tian; Andrew N. Hoofnagle; Lorin M. Bachmann; Ian S. Young; Juanita Pettit; Grahame Caldwell; Andrew Liu; Stephen P.J. Brooks; Kurtis Sarafin; Michael Thamm; Gert B.M. Mensink; Markus Busch; Martina Rabenberg; Kevin D. Cashman; Mairead Kiely; Michael Kinsella; Karen Galvin; Joy Y. Zhang; Kyungwon Oh; Sun Wha Lee; Chae L. Jung; Lorna Cox; Gail Goldberg; Kate Guberg; Ann Prentice; Graham D. Carter; Julia Jones; Patsy M. Brannon; Robyn M. Lucas; Peter M. Crump; Etienne Cavalier; Joyce Merkel; Joseph M. Betz; Christopher T. Sempos

doi:10.5740/jaoacint.17-0258

Baseline assessment of 25-hydroxyVitamin D assay performance: A Vitamin D standardization program (VDSP) interlaboratory comparison study

Stephen A. Wise^*, Karen W. Phinney, Susan S.C. Tai, Johanna E. Camara, Gary L. Myers, Ramon Durazo-Arvizu, Lu Tian, Andrew N. Hoofnagle, Lorin M. Bachmann, Ian S. Young, Juanita Pettit, Grahame Caldwell, Andrew Liu, Stephen P.J. Brooks, Kurtis Sarafin, Michael Thamm, Gert B.M. Mensink, Markus Busch, Martina Rabenberg, Kevin D. CashmanMairead Kiely, Michael Kinsella, Karen Galvin, Joy Y. Zhang, Kyungwon Oh, Sun Wha Lee, Chae L. Jung, Lorna Cox, Gail Goldberg, Kate Guberg, Ann Prentice, Graham D. Carter, Julia Jones, Patsy M. Brannon, Robyn M. Lucas, Peter M. Crump, Etienne Cavalier, Joyce Merkel, Joseph M. Betz, Christopher T. Sempos

^*Corresponding author for this work

Research output: Contribution to journal › Review article › peer-review

52 Citations (Scopus)

Abstract

The Vitamin D Standardization Program (VDSP) coordinated an interlaboratory study to assess the comparability of measurements of total 25-hydroxyVitamin D [25(OH)D] in human serum, which is the primary marker of Vitamin D status. A set of 50 individual donor samples were analyzed by 15 different laboratories representing national nutrition surveys, assay manufacturers, and clinical and/or research laboratories to provide results for total 25(OH)D using both immunoassays (IAs) and LC tandem MS (MS/MS). The results were evaluated relative to bias compared with the target values assigned based on a combination of measurements at Ghent University (Belgium) and the U.S. National Institute of Standards and Technology using reference measurement procedures for the determination of 25(OH)D2 and 25(OH)D3. CV and mean bias for each laboratory and assay platform were assessed and compared with previously established VDSP performance criteria, namely CV ≤ 10% and mean bias ≤ 5%. Nearly all LC-MS/MS results achieved VDSP criteria, whereas only 50% of IAs met the criterion for a ≤10% CV and only three of eight IAs achieved the ≤5% bias. These results establish a benchmark for the evaluation of 25(OH)D assay performance and standardization activities in the future.

Original language	English
Pages (from-to)	1244-1252
Number of pages	9
Journal	Journal of AOAC International
Volume	100
Issue number	5
DOIs	https://doi.org/10.5740/jaoacint.17-0258
Publication status	Published - 1 Sept 2017

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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., ... Sempos, C. T. (2017). Baseline assessment of 25-hydroxyVitamin D assay performance: A Vitamin D standardization program (VDSP) interlaboratory comparison study. Journal of AOAC International, 100(5), 1244-1252. https://doi.org/10.5740/jaoacint.17-0258

@article{42fa173011c146f29b27d63a826b4dd6,

title = "Baseline assessment of 25-hydroxyVitamin D assay performance: A Vitamin D standardization program (VDSP) interlaboratory comparison study",

abstract = "The Vitamin D Standardization Program (VDSP) coordinated an interlaboratory study to assess the comparability of measurements of total 25-hydroxyVitamin D [25(OH)D] in human serum, which is the primary marker of Vitamin D status. A set of 50 individual donor samples were analyzed by 15 different laboratories representing national nutrition surveys, assay manufacturers, and clinical and/or research laboratories to provide results for total 25(OH)D using both immunoassays (IAs) and LC tandem MS (MS/MS). The results were evaluated relative to bias compared with the target values assigned based on a combination of measurements at Ghent University (Belgium) and the U.S. National Institute of Standards and Technology using reference measurement procedures for the determination of 25(OH)D2 and 25(OH)D3. CV and mean bias for each laboratory and assay platform were assessed and compared with previously established VDSP performance criteria, namely CV ≤ 10% and mean bias ≤ 5%. Nearly all LC-MS/MS results achieved VDSP criteria, whereas only 50% of IAs met the criterion for a ≤10% CV and only three of eight IAs achieved the ≤5% bias. These results establish a benchmark for the evaluation of 25(OH)D assay performance and standardization activities in the future.",

author = "Wise, {Stephen A.} and Phinney, {Karen W.} and Tai, {Susan S.C.} and Camara, {Johanna E.} and Myers, {Gary L.} and Ramon Durazo-Arvizu and Lu Tian and Hoofnagle, {Andrew N.} and Bachmann, {Lorin M.} and Young, {Ian S.} and Juanita Pettit and Grahame Caldwell and Andrew Liu and Brooks, {Stephen P.J.} and Kurtis Sarafin and Michael Thamm and Mensink, {Gert B.M.} and Markus Busch and Martina Rabenberg and Cashman, {Kevin D.} and Mairead Kiely and Michael Kinsella and Karen Galvin and Zhang, {Joy Y.} and Kyungwon Oh and Lee, {Sun Wha} and Jung, {Chae L.} and Lorna Cox and Gail Goldberg and Kate Guberg and Ann Prentice and Carter, {Graham D.} and Julia Jones and Brannon, {Patsy M.} and Lucas, {Robyn M.} and Crump, {Peter M.} and Etienne Cavalier and Joyce Merkel and Betz, {Joseph M.} and Sempos, {Christopher T.}",

year = "2017",

month = sep,

day = "1",

doi = "10.5740/jaoacint.17-0258",

language = "English",

volume = "100",

pages = "1244--1252",

journal = "Journal of AOAC International",

issn = "1060-3271",

publisher = "AOAC International",

number = "5",

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Wise, SA, Phinney, KW, Tai, SSC, Camara, JE, Myers, GL, Durazo-Arvizu, R, Tian, L, Hoofnagle, AN, Bachmann, LM, Young, IS, Pettit, J, Caldwell, G, Liu, A, Brooks, SPJ, Sarafin, K, Thamm, M, Mensink, GBM, Busch, M, Rabenberg, M, Cashman, KD, Kiely, M, Kinsella, M, Galvin, K, Zhang, JY, Oh, K, Lee, SW, Jung, CL, Cox, L, Goldberg, G, Guberg, K, Prentice, A, Carter, GD, Jones, J, Brannon, PM, Lucas, RM, Crump, PM, Cavalier, E, Merkel, J, Betz, JM & Sempos, CT 2017, 'Baseline assessment of 25-hydroxyVitamin D assay performance: A Vitamin D standardization program (VDSP) interlaboratory comparison study', Journal of AOAC International, vol. 100, no. 5, pp. 1244-1252. https://doi.org/10.5740/jaoacint.17-0258

TY - JOUR

T1 - Baseline assessment of 25-hydroxyVitamin D assay performance

T2 - A Vitamin D standardization program (VDSP) interlaboratory comparison study

AU - Wise, Stephen A.

AU - Phinney, Karen W.

AU - Tai, Susan S.C.

AU - Camara, Johanna E.

AU - Myers, Gary L.

AU - Durazo-Arvizu, Ramon

AU - Tian, Lu

AU - Hoofnagle, Andrew N.

AU - Bachmann, Lorin M.

AU - Young, Ian S.

AU - Pettit, Juanita

AU - Caldwell, Grahame

AU - Liu, Andrew

AU - Brooks, Stephen P.J.

AU - Sarafin, Kurtis

AU - Thamm, Michael

AU - Mensink, Gert B.M.

AU - Busch, Markus

AU - Rabenberg, Martina

AU - Cashman, Kevin D.

AU - Kiely, Mairead

AU - Kinsella, Michael

AU - Galvin, Karen

AU - Zhang, Joy Y.

AU - Oh, Kyungwon

AU - Lee, Sun Wha

AU - Jung, Chae L.

AU - Cox, Lorna

AU - Goldberg, Gail

AU - Guberg, Kate

AU - Prentice, Ann

AU - Carter, Graham D.

AU - Jones, Julia

AU - Brannon, Patsy M.

AU - Lucas, Robyn M.

AU - Crump, Peter M.

AU - Cavalier, Etienne

AU - Merkel, Joyce

AU - Betz, Joseph M.

AU - Sempos, Christopher T.

PY - 2017/9/1

Y1 - 2017/9/1

N2 - The Vitamin D Standardization Program (VDSP) coordinated an interlaboratory study to assess the comparability of measurements of total 25-hydroxyVitamin D [25(OH)D] in human serum, which is the primary marker of Vitamin D status. A set of 50 individual donor samples were analyzed by 15 different laboratories representing national nutrition surveys, assay manufacturers, and clinical and/or research laboratories to provide results for total 25(OH)D using both immunoassays (IAs) and LC tandem MS (MS/MS). The results were evaluated relative to bias compared with the target values assigned based on a combination of measurements at Ghent University (Belgium) and the U.S. National Institute of Standards and Technology using reference measurement procedures for the determination of 25(OH)D2 and 25(OH)D3. CV and mean bias for each laboratory and assay platform were assessed and compared with previously established VDSP performance criteria, namely CV ≤ 10% and mean bias ≤ 5%. Nearly all LC-MS/MS results achieved VDSP criteria, whereas only 50% of IAs met the criterion for a ≤10% CV and only three of eight IAs achieved the ≤5% bias. These results establish a benchmark for the evaluation of 25(OH)D assay performance and standardization activities in the future.

AB - The Vitamin D Standardization Program (VDSP) coordinated an interlaboratory study to assess the comparability of measurements of total 25-hydroxyVitamin D [25(OH)D] in human serum, which is the primary marker of Vitamin D status. A set of 50 individual donor samples were analyzed by 15 different laboratories representing national nutrition surveys, assay manufacturers, and clinical and/or research laboratories to provide results for total 25(OH)D using both immunoassays (IAs) and LC tandem MS (MS/MS). The results were evaluated relative to bias compared with the target values assigned based on a combination of measurements at Ghent University (Belgium) and the U.S. National Institute of Standards and Technology using reference measurement procedures for the determination of 25(OH)D2 and 25(OH)D3. CV and mean bias for each laboratory and assay platform were assessed and compared with previously established VDSP performance criteria, namely CV ≤ 10% and mean bias ≤ 5%. Nearly all LC-MS/MS results achieved VDSP criteria, whereas only 50% of IAs met the criterion for a ≤10% CV and only three of eight IAs achieved the ≤5% bias. These results establish a benchmark for the evaluation of 25(OH)D assay performance and standardization activities in the future.

UR - http://www.scopus.com/inward/record.url?scp=85029536930&partnerID=8YFLogxK

U2 - 10.5740/jaoacint.17-0258

DO - 10.5740/jaoacint.17-0258

M3 - Review article

SN - 1060-3271

VL - 100

SP - 1244

EP - 1252

JO - Journal of AOAC International

JF - Journal of AOAC International

IS - 5

ER -

Baseline assessment of 25-hydroxyVitamin D assay performance: A Vitamin D standardization program (VDSP) interlaboratory comparison study

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