Correlation among 25-hydroxy-vitamin D assays
Correlation among 25-hydroxy-vitamin D assays
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DOI：
10.1210/jc.2007-2340
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发表时间：
2008-05-01
影响因子：
5.8
通讯作者：
Drezner, M. K.
中科院分区：
文献类型：
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作者：
Binkley, N.;Krueger, D.;Drezner, M. K.
背景：测量循环中的25-羟基维生素D [ 25（OH）D]是公认的维生素D状态的临床指标。然而，实验室之间的差异，在测量这种分析物的存在，这可能会混淆clinicalcare.Objectives：我们调查了目前的协议25（OH）D测量在临床实验室和探讨的可能性，简单的校准将提高实验室之间的协议。设计和参与者：从健康志愿者获得的血清（年龄20-60岁）和一个“校准品”（选择具有接近30 ng/ml的25（OH）D值）被送到四个临床实验室进行25（OH）D测量（实验室A-D）使用HPLC、液相色谱串联质谱法和RIA方法。根据自我报告，将具有最低批间变异系数百分比的实验室指定为参考，使用线性回归和Bland-Altman分析（Analyse-it; Analyse-it Software，Ltd.，利兹，英国）。实验室A和实验室B-D之间的25（OH）D测量结果具有良好的相关性（R-2分别= 0.99、0.81和0.95）。观察到实验室间存在中度变异;平均偏倚范围为2.9-5.2 ng/ml。与系统偏移一致，实验室B的每个值均高于实验室A，实验室B-D的89%的值高于实验室A。使用单一校准品和校正因子降低了实验室B和D的平均实验室间偏倚。结论：临床实验室测量25（OH）D产生相似的结果。即使使用单个校准品也会改善但不能解决实验室间的变异性。基于这些数据，结合报告的个体内变异性，我们建议临床医生将患者的目标值设定为大于30 ng/ml。
Context: Measurement of circulating 25-hydroxy-vitamin D [ 25(OH) D]) is the accepted clinical indicator of vitamin D status. However, between-laboratory differences in measurement of this analyte exist, which may confound clinical care.Objectives: We investigated the current agreement of 25(OH) D measurement in clinical laboratories and explored the possibility that simple calibration would improve between-laboratory agreement.Design and Participants: Serum obtained from healthy volunteers (age 20-60 yr) and one "calibrator," selected to have a 25(OH) D value near 30 ng/ml, were sent for 25(OH) D measurement in four clinical laboratories (laboratories A-D) using HPLC, liquid chromatography tandem mass spectroscopy, and RIA methodologies.Main Outcome Measures: Serum 25(OH) D. Based upon self-report, the laboratory with the lowest interassay percent coefficient of variation was assigned as the reference to which the others were compared using linear regression and Bland-Altman analyses (Analyse-it; Analyse-it Software, Ltd., Leeds, UK).Results: Good correlation was observed for 25(OH) D measurement between laboratory A and laboratories B-D(R-2 = 0.99, 0.81, and 0.95, respectively). Modest between-laboratory variation was noted; the mean bias ranged from 2.9-5.2 ng/ml. Consistent with a systematic offset, each value in laboratory B was higher than in laboratory A, and 89% of values from laboratories B-D were higher than laboratory A. The use of a single calibrator and correction factor reduced mean between-laboratory bias for laboratories B and D.Conclusions: Measurement of 25(OH) D by clinical laboratories yields similar results. The use of even a single calibrator will improve, but not resolve, between-laboratory variability. Based upon these data, in combination with reported within-individual variability, we recommend that clinicians aim for values greater than 30 ng/ml in their patients.