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

Research output: Contribution to journalReview articlepeer-review

37 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 languageEnglish
Pages (from-to)1244-1252
Number of pages9
JournalJournal of AOAC International
Volume100
Issue number5
DOIs
Publication statusPublished - 01 Sep 2017
Externally publishedYes

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