Assay variation confounds the diagnosis of hypovitaminosis D: A call for standardization
Assay variation confounds the diagnosis of hypovitaminosis D: A call for standardization
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DOI：
10.1210/jc.2003-031979
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发表时间：
2004-07-01
影响因子：
5.8
通讯作者：
Drezner, MK
中科院分区：
文献类型：
--
作者：
Binkley, N;Krueger, D;Drezner, MK
地方性维生素D缺乏导致骨质疏松症的发生。然而，25-羟基维生素D(25OHD)测定的变异被报道并混淆了维生素D不足/缺乏的诊断。这份报告强调了不同实验室间血清25OHD测定的显著变异性。最初，绝经后妇女进行了血清25OHD测定：A实验室42人，B实验室20人。A和B实验室的血清25OHD平均浓度(扫描电子显微镜)分别为46(2.1)和21(2.3)ng/ml。此外，在这些临床相似的个体中，血清25OHD几乎没有重叠。具体地说，在实验室A测得的样本中有17%低于32 ng/毫升的任意阈值，而在实验室B中测得的样本中有90%低于32 ng/毫升的任意阈值。从每个人身上取两份等量，其中一份添加了20 ng/ml25OHD，被送往六个实验室。注意到这六个实验室之间存在很大的差异。血清25OHD的平均浓度范围为17.1-35.6 ng/ml。同样，添加20 ng/ml的浓度所产生的平均增加范围为7.7-18.0 ng/ml。总而言之，25OHD的检测结果明显不同；一个人是否被发现维生素D水平低下或正常取决于所使用的实验室。如果医学界要在纠正普遍的维生素D缺乏症方面取得进展，25OHD测量必须标准化。
Endemic hypovitaminosis D contributes to osteoporosis development. However, variation in 25-hydroxyvitamin D (25OHD) measurement is reported and confounds the diagnosis of vitamin D insufficiency/deficiency. This report emphasizes the marked variability observed in serum 25OHD measurements between laboratories.Initially, postmenopausal women had serum 25OHD determinations: 42 in laboratory A, 20 in laboratory B. Their mean (SEM) serum 25OHD concentrations were 46 (2.1) and 21 (2.3) ng/ml in laboratories A and B, respectively. Furthermore, there was little overlap in serum 25OHD among these clinically similar individuals. Specifically, 17% of those measured in laboratory A but 90% in laboratory B were below an arbitrary threshold value of 32 ng/ml.Subsequently, serum was obtained from 10 healthy adults. Two aliquots from each individual, one of which was spiked with 20 ng/ml 25OHD, were sent to six laboratories. Substantial variability was noted between these six laboratories. The mean serum 25OHD concentration ranged from 17.1-35.6 ng/ml. Similarly, the mean increase produced by spiking with 20 ng/ml ranged from 7.7-18.0 ng/ml.In conclusion, 25OHD assays yield markedly differing results; whether an individual is found to have low or normal vitamin D status is a function of the laboratory used. If the medical community is to make progress in correcting widespread hypovitaminosis D, 25OHD measurement must be standardized.