Binkley Neil, Sempos Christopher T
Osteoporosis Clinical Research Program and Institute on Aging, University of Wisconsin-Madison, Madison, WI, USA.
J Bone Miner Res. 2014 Aug;29(8):1709-14. doi: 10.1002/jbmr.2252.
For a number of years it has been widely assumed that measurement of serum 25-hydroxyvitamin D [25(OH)D] concentration is the best approach to assessing an individual's vitamin D status. However, it has also been recognized that there is substantial within-assay variation in 25(OH)D measurement and even greater between-assay variability. Such assay variation clearly confounds attempts to define what constitutes the diagnosis of hypovitaminosis D. Importantly, assay variability makes pooling of 25(OH)D results from different studies in systematic reviews for the specific purpose of determining dose-response and/or clinical cut points at best problematic. Therefore, to develop and implement evidence-based clinical guidelines, it is essential that 25(OH)D measurement be standardized in both clinical and research laboratories. In this Perspective we outline a way forward toward achieving this goal-the Vitamin D Standardization Program (VDSP).
多年来,人们普遍认为测量血清25-羟维生素D[25(OH)D]浓度是评估个体维生素D状态的最佳方法。然而,人们也认识到,25(OH)D测量存在显著的批内变异,批间变异甚至更大。这种检测变异显然混淆了维生素D缺乏症诊断标准的界定。重要的是,检测变异性使得在系统评价中为确定剂量反应和/或临床切点这一特定目的而汇总不同研究的25(OH)D结果变得极具问题。因此,为了制定和实施基于证据的临床指南,临床和研究实验室对25(OH)D测量进行标准化至关重要。在本观点文章中,我们概述了实现这一目标的前进方向——维生素D标准化计划(VDSP)。