Baseline Assessment of 25-Hydroxyvitamin D Assay Performance: A Vitamin D Standardization Program (ASP) Interlaboratory Comparison Study

被引：46

作者：

Wise, Stephen A. ^{[1
,2
]}

Phinney, Karen W. ^{[2
]}

Tai, Susan S. -C. ^{[2
]}

Camara, Johanna E. ^{[2
]}

Myers, Gary L. ^{[3
]}

Durazo-Arvizu, Ramon ^{[4
]}

Tian, Lu ^{[5
]}

Hoofnagle, Andrew N. ^{[6
]}

Bachmann, Lorin M. ^{[7
]}

Young, Ian S. ^{[8
]}

Pettit, Juanita ^{[9
]}

Caldwell, Grahame ^{[10
]}

Liu, Andrew ^{[10
]}

Brooks, Stephen P. J. ^{[11
]}

Sarafin, Kurtis ^{[11
]}

Thamm, Michael ^{[12
]}

Mensink, Gert B. M. ^{[12
]}

Busch, Markus ^{[12
]}

Rabenberg, Martina ^{[12
]}

Cashman, Kevin D. ^{[13
]}

Kiely, Mairead ^{[13
]}

Kinsella, Michael ^{[13
]}

Galvin, Karen ^{[13
]}

Zhang, Joy Y. ^{[13
]}

Oh, Kyungwon ^{[14
]}

Lee, Sun-Wha ^{[15
]}

Jung, Chae L. ^{[15
]}

Cox, Lorna ^{[16
]}

Goldberg, Gail ^{[16
]}

Guberg, Kate ^{[16
]}

Prentice, Ann ^{[16
]}

Carter, Graham D. ^{[17
]}

Jones, Julia ^{[17
]}

Brannon, Patsy M. ^{[18
]}

Lucas, Robyn M. ^{[19
]}

Crump, Peter M. ^{[20
]}

Cavalier, Etienne ^{[21
]}

Merkel, Joyce ^{[1
]}

Betz, Joseph M. ^{[1
]}

Sempos, Christopher T. ^{[1
]}

机构：

[1] NIH, Off Dietary Supplements, Bethesda, MD 20892 USA

[2] NIST, Chem Sci Div, Gaithersburg, MD 20899 USA

[3] Joint Comm Traceabil Lab Med, Smyrna, GA USA

[4] Loyola Univ Chicago, Dept Publ Hlth Sci, Chicago, IL USA

[5] Stanford Univ, Dept Hlth Res & Policy Biostat, Palo Alto, CA 94304 USA

[6] Univ Washington, Dept Lab Med, Seattle, WA 98195 USA

[7] Virginia Commonwealth Univ, Richmond, VA USA

[8] Queens Univ, Belfast, Antrim, North Ireland

[9] Australian Bur Stat, Canberra, ACT, Australia

[10] Son Healthcare, Douglass Hanly Moir Pathol, Sydney, NSW, Australia

[11] Hlth Canada, Nutr Res Div, Ottawa, ON, Canada

[12] Robert Koch Inst, Berlin, Germany

[13] Univ Coll Cork, Sch Food & Nutr Sci, Cork Ctr Vitamin & Nutr Res D, Cork, Ireland

[14] Korea Ctr Dis Control & Prevent, Seoul, South Korea

[15] Neodin Med Inst, Seoul, South Korea

[16] MRC, Elsie Widdowson Lab, Cambridge, England

[17] Charing Cross Hosp, Vitamin External Qual Assessment Scheme D, London, England

[18] Cornell Univ, Div Nutr Sci, Ithaca, NY 14853 USA

[19] Australian Natl Univ, Res Sch Populat Hlth, Natl Ctr Epidemiol & Populat Hlth, Canberra, ACT, Australia

[20] Univ Wisconsin Madison, Comp & Biometry, Madison, WI USA

[21] Univ Liege, CHU Liege Sart Tilman, Liege, Belgium

来源：

JOURNAL OF AOAC INTERNATIONAL | 2017年 / 100卷 / 05期

基金：

英国医学研究理事会;

关键词：

TANDEM MASS-SPECTROMETRY; HUMAN SERUM; D-2;

D O I：

10.5740/jaoacint.17-0258

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

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)D-2 and 25(OH)D-3. 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.

引用

页码：1244 / 1252

页数：9

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