Performance evaluation of four 25-hydroxyvitamin D assays to measure 25-hydroxyvitamin D2
Performance evaluation of four 25-hydroxyvitamin D assays to measure 25-hydroxyvitamin D2
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DOI：
10.1016/j.clinbiochem.2015.05.021
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发表时间：
2015-11-01
影响因子：
2.8
通讯作者：
Sibley, Paul
中科院分区：
文献类型：
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作者：
Freeman, James;Wilson, Kimberly;Sibley, Paul
目的：当前免疫分析准确测量等摩尔量 25(OH)D-2 和 25(OH)D-3 的能力最近受到质疑。本研究通过同位素稀释液相色谱质谱法 (ID-LC-MS/MS) 测定了补充维生素 D-2 的健康受试者的血清 25(OH)D-2、25(OH)D-3 和总血清 25(OH)D 浓度；并评估了西门子、DiaSorin、Roche 和 Abbott 维生素 D 总测定法与可追溯至美国国家标准与技术研究院 (NIST) 的 ID-LC-MS/MS 方法相比监测总血清 25(OH)D 浓度的能力，该方法已获得美国疾病控制与预防中心 (CDC) 维生素 D 标准化认证计划 (VDSCP) 的认证。 设计和方法： 二十 (20) 名之前没有补充维生素 D 史的健康成年人口服维生素 D-2（2400 IU/天，持续 6 个月）。对基线和每月抽血的血清样本 (140) 进行了测试。结果：1 个月后，平均血清 25(OH)D-2 浓度从 0.8 nmol/L 上升至 43.6 nmol/L，而 25(OH)D3 浓度从 84.0 nmol/L 下降至 63.4 nmol/L；血清总 25(OH)D 浓度从 86.6 nmol/L 升至 107.0 nmol/L。对于西门子 ADVIA Centaur 测定，ID-LC-MS/MS 的总体平均偏差为 -7.1%；对于 DiaSorin LIAISON 测定，ID-LC-MS/MS 的总体平均偏差为 -15.3%； Roche ELECSYS 测定为 -8.4%，Abbott ARCHITECT 测定为 -16.3%。相关系数（r）为0.94、0.79、0.74和0.73；基线[含有 25(OH)D-3] 与六个月[含有 25(OH)D-2 和 25(OH)D-3] 样本的平均偏差分别为 -13.4% 和 -5.7%；分别为 -3.5% 和 20.3%、9.6% 和 -12.1%、0.2% 和 -17.8%。 结论：Siemens ADVIA Centaur 测定和 Roche ELECSYS 测定获得的偏倚结果略低于 DiaSorin LIAISON 测定和 Abbott ARCHITECT 测定的偏倚结果，但所有 25(OH)D 测定均表现出可接受的性能。 (C) 2015 年西门子医疗诊断公司。加拿大临床化学家协会。由爱思唯尔公司出版
Objectives: The ability of current immunoassays to accurately measure equimolar amounts of 25(OH)D-2 and 25(OH)D-3 has been recently questioned. This study determined serum 25(OH)D-2, 25(OH)D-3 and total serum 25(OH)D concentrations in healthy vitamin D-2-supplemented subjects by isotope dilution liquid chromatography mass spectrometry (ID-LC-MS/MS); and, evaluated the ability of the Siemens, DiaSorin, Roche, and Abbott Vitamin D Total assays to monitor total serum 25(OH)D concentrations compared to an ID-LC-MS/MS method traceable to the National Institute of Standards and Technology (NIST), and that has achieved certification from the Centers for Disease Control and Prevention (CDC) Vitamin D Standardization Certification Program (VDSCP).Design and methods: Twenty (20) healthy adults, with no history of prior vitamin D supplementation were administered oral vitamin D-2 (2400 IU/day for 6 months). Serum samples (140) from baseline and monthly blood draws were tested.Results: After one month, the mean serum 25(OH)D-2 concentrations rose from 0.8 to 43.6 nmol/L, whereas 25(OH)D3 concentrations declined from 84.0 to 63.4 nmol/L; total serum 25(OH)D concentrations rose from 86.6 to 107.0 nmol/L. The overall mean bias to ID-LC-MS/MS was -7.1% for the Siemens ADVIA Centaur assay, -15.3% for the DiaSorin LIAISON assay; -8.4% for the Roche ELECSYS assay and -16.3% for the Abbott ARCHITECT assay. Correlation coefficients (r) were 0.94, 0.79, 0.74, and 0.73; the mean bias for baseline [25(OH) D-3-containing] versus six-month [25(OH)D-2- and 25(OH)D-3-containing] samples was -13.4% and -5.7%; -3.5% and 20.3%, 9.6% and -12.1%, and 0.2% and -17.8%, respectively.Conclusions: The bias results obtained for the Siemens ADVIA Centaur assay and Roche ELECSYS assay were slightly lower than those for the DiaSorin LIAISON assay and the Abbott ARCHITECT assay, but all 25(OH)D assays demonstrated acceptable performance. (C) 2015 Siemens Healthcare Diagnostics Inc. The Canadian Society of Clinical Chemists. Published by Elsevier Inc.