Baseline Assessment of 25-Hydroxyvitamin D Assay Performance: A Vitamin D Standardization Program (VDSP) Interlaboratory Comparison Study
Autor: | Kevin D. Cashman, Lorin M. Bachmann, Gail R Goldberg, Martina Rabenberg, Kurtis Sarafin, P.M. Crump, Andrew Liu, Johanna E. Camara, Michael Kinsella, Joyce Merkel, R. Durazo-Arvizu, Gert B. M. Mensink, Etienne Cavalier, Gary L. Myers, Kate Guberg, Stephen P. J. Brooks, Susan S.-C. Tai, Chae L. Jung, Kyungwon Oh, Michael Thamm, G D Carter, Ann Prentice, Karen Galvin, Lu Tian, Lorna Cox, Juanita Pettit, Sun-Wha Lee, Julia Jones, Stephen A. Wise, Robyn M. Lucas, Christopher T. Sempos, Patsy M. Brannon, J. Y. Zhang, Grahame Caldwell, Joseph M. Betz, Karen W. Phinney, Markus A. Busch, Ian S. Young, Mairead Kiely, Andrew N. Hoofnagle |
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Rok vydání: | 2017 |
Předmět: |
0301 basic medicine
Standardization 030209 endocrinology & metabolism Analytical Chemistry 03 medical and health sciences 0302 clinical medicine Tandem Mass Spectrometry Vitamin D and neurology Environmental Chemistry Medicine Humans Vitamin D Reference standards Pharmacology Immunoassay 030109 nutrition & dietetics Chromatography business.industry Reference Standards Reference measurement Comparison study business Agronomy and Crop Science Blood Chemical Analysis Food Science Chromatography Liquid |
Zdroj: | Journal of AOAC International. 100(5) |
ISSN: | 1944-7922 |
Popis: | 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 laboratoriesrepresenting 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 resultswere 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. |
Databáze: | OpenAIRE |
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