Martins-Costa Paula, Martins Helena, Bravo Fernanda, Cruz Madalena, Reis Júlia, Oliveira José Carlos
Centro Hospitalar do Porto, Hospital de Santo António, Serviço de Química Clínica, Porto, Portugal.
Clin Lab. 2013;59(7-8):885-91. doi: 10.7754/clin.lab.2012.120924.
The objective of the study was to compare the analytical performance of three automated immunoassays for the determination of serum 25-hydroxyvitamin D.
Quantitative determination of serum 25(OH)D were performed by "Vitamin D total" (n = 131) and "Vitamin D3(25-OH)" (n = 77) assays (Roche Diagnostics) on a Cobas e411 and by "25-OH Vitamin D" (n = 131) assay (Abbott Laboratories) on an Architect. The inter-assay precision was calculated and methods were compared by the Passing Bablok regression and Bland-Altman analysis.
The "Vitamin D total" demonstrated stronger correlation (r = 0.863) and better agreement (bias = -7.89 nmol/L) with the "25-OH Vitamin D" than with the "Vitamin D3(25-OH)" (r = 0.716; bias = +18.6 nmol/L). The inter-assay precision (% CV) for the "Vitamin D total" and "25-OH Vitamin D" assays, were respectively 3.47 to 6.14 and 4.27 to 8.56.
The results of this study demonstrate that Abbott "25-OH Vitamin D" and Roche "Vitamin D total" are rapid and precise methods for 25(OH)D serum measurement over a wide reportable range on automated immunoassay platforms. The Abbott assay exhibited better correlation and agreement with the new Roche assay than the "Vitamin D3(25-OH)" Roche assay. Between method differences observed in this study still indicates the need for standardization of 25(OH)D assays.
本研究的目的是比较三种自动化免疫测定法测定血清25-羟基维生素D的分析性能。
在Cobas e411上采用“总维生素D”(n = 131)和“维生素D3(25-OH)”(n = 77)测定法(罗氏诊断公司)对血清25(OH)D进行定量测定,并在Architect上采用“25-羟基维生素D”(n = 131)测定法(雅培实验室)进行测定。计算批间精密度,并通过帕氏-巴布洛克回归分析和布兰德-奥特曼分析对方法进行比较。
与“维生素D3(25-OH)”(r = 0.716;偏差 = +18.6 nmol/L)相比,“总维生素D”与“25-羟基维生素D”的相关性更强(r = 0.863),一致性更好(偏差 = -7.89 nmol/L)。“总维生素D”和“25-羟基维生素D”测定法的批间精密度(%CV)分别为3.47至6.14和4.27至8.56。
本研究结果表明,雅培的“25-羟基维生素D”和罗氏的“总维生素D”是在自动化免疫测定平台上对25(OH)D血清进行宽报告范围测量的快速、精确方法。与罗氏的“维生素D3(25-OH)”测定法相比,雅培的测定法与罗氏的新测定法具有更好的相关性和一致性。本研究中观察到的方法间差异仍表明25(OH)D测定法需要标准化。