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, Merkel Joyce, Betz Joseph M, Sempos Christopher T
National Institutes of Health, Office of Dietary Supplements, Bethesda, MD 20892.
National Institute of Standards and Technology, Chemical Sciences Division, Gaithersburg, MD.
J AOAC Int. 2017 Sep 1;100(5):1244-1252. doi: 10.5740/jaoacint.17-0258. Epub 2017 Aug 19.
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.
维生素D标准化计划（VDSP）协调了一项实验室间研究，以评估人血清中总25-羟基维生素D [25(OH)D] 测量值的可比性，25(OH)D是维生素D状态的主要标志物。来自代表国家营养调查、检测试剂盒制造商以及临床和/或研究实验室的15个不同实验室，对一组50份个体捐赠者样本进行了分析，以使用免疫测定法（IAs）和液相色谱串联质谱法（MS/MS）提供总25(OH)D的检测结果。将结果与基于比利时根特大学和美国国家标准与技术研究院使用参考测量程序测定25(OH)D2和25(OH)D3的测量值组合所指定的目标值进行偏差比较评估。评估了每个实验室和检测平台的变异系数（CV）和平均偏差，并与先前确定的VDSP性能标准进行比较，即CV≤10%且平均偏差≤5%。几乎所有的液相色谱-质谱联用（LC-MS/MS）结果都达到了VDSP标准，而只有50%的免疫测定法满足CV≤10%的标准，并且8种免疫测定法中只有3种达到了≤5%的偏差。这些结果为未来评估25(OH)D检测性能和标准化活动建立了一个基准。
