[en] 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.
Disciplines :
Laboratory medicine & medical technology
Author, co-author :
Wise, Stephen A.
Phinney, Karen W.
Tai, Susan S.-C.
Camara, Johanna E.
Myers, Gary L.
Durazo-Arvizu, Ramon
Tian, Lu
Hoofnagle, Andrew N.
Bachmann, Lorin M.
Young, Ian S.
Pettit, Juanita
Caldwell, Grahame
Liu, Andrew
Brooks, Stephen P. J.
Sarafin, Kurtis
Thamm, Michael
Mensink, Gert B. M.
Busch, Markus
Rabenberg, Martina
Cashman, Kevin D.
Kiely, Mairead
Kinsella, Michael
Galvin, Karen
Zhang, Joy Y.
Oh, Kyungwon
Lee, Sun-Wha
Jung, Chae L.
Cox, Lorna
Goldberg, Gail
Guberg, Kate
Prentice, Ann
Carter, Graham D.
Jones, Julia
Brannon, Patsy M.
Lucas, Robyn M.
Crump, Peter M.
Cavalier, Etienne ; Université de Liège - ULiège > Département de pharmacie > Chimie médicale
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