Freeman James, Wilson Kimberly, Spears Ryan, Shalhoub Victoria, Sibley Paul
Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, NY 10591, USA.
Clin Biochem. 2015 Nov;48(16-17):1097-104. doi: 10.1016/j.clinbiochem.2015.05.021. Epub 2015 Jun 6.
The ability of current immunoassays to accurately measure equimolar amounts of 25(OH)D2 and 25(OH)D3 has been recently questioned. This study determined serum 25(OH)D2, 25(OH)D3 and total serum 25(OH)D concentrations in healthy vitamin D2-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).
Twenty (20) healthy adults, with no history of prior vitamin D supplementation were administered oral vitamin D2 (2400IU/day for 6months). Serum samples (140) from baseline and monthly blood draws were tested.
After one month, the mean serum 25(OH)D2 concentrations rose from 0.8 to 43.6nmol/L, whereas 25(OH)D3 concentrations declined from 84.0 to 63.4nmol/L; total serum 25(OH)D concentrations rose from 86.6 to 107.0nmol/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) D3-containing] versus six-month [25(OH)D2- and 25(OH)D3-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.
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.
当前免疫测定法准确测量等摩尔量的25(OH)D2和25(OH)D3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联用技术（ID-LC-MS/MS）测定了健康的补充维生素D2受试者的血清25(OH)D2、25(OH)D3和总血清25(OH)D浓度；并评估了西门子、索灵、罗氏和雅培维生素D总检测法与可溯源至美国国家标准与技术研究院（NIST）且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）认证的ID-LC-MS/MS方法相比，监测总血清25(OH)D浓度的能力。
二十（20）名无维生素D补充史的健康成年人口服维生素D2（2400IU/天，持续6个月）。对基线和每月采血的血清样本（共140份）进行检测。
一个月后，血清25(OH)D2的平均浓度从0.8nmol/L升至43.6nmol/L，而25(OH)D3的浓度从84.0nmol/L降至63.4nmol/L；总血清25(OH)D浓度从86.6nmol/L升至107.0nmol/L。与ID-LC-MS/MS相比，西门子ADVIA Centaur检测法的总体平均偏差为-7.1%，索灵LIAISON检测法为-15.3%；罗氏ELECSYS检测法为-8.4%，雅培ARCHITECT检测法为-16.3%。相关系数（r）分别为0.94、0.79、0.74和0.73；基线[含25(OH)D3]样本与六个月[含25(OH)D2和25(OH)D3]样本的平均偏差分别为-13.4%和-5.7%；-3.5%和20.3%，9.6%和-12.1%，以及0.2%和-17.8%。
西门子ADVIA Centaur检测法和罗氏ELECSYS检测法的偏差结果略低于索灵LIAISON检测法和雅培ARCHITECT检测法，但所有25(OH)D检测法均表现出可接受的性能。
