Nguyen Van Thi Quynh, Li Xianjun, Castellanos Karla Josephine, Fantuzzi Giamila, Mazzone Theodore, Braunschweig Carol Arbron
J AOAC Int. 2014 Jul-Aug;97(4):1048-55. doi: 10.5740/jaoacint.13-305.
Serum samples from 74 obese women were assayed for 25-hydroxyvitamin D [25(OH)D] concentrations using an automated immunoassay [Architect (Abbott)] and ELISA (Alpco Diagnostics), and results were compared with the LC/MS/MS reference method (Quest Diagnostics). The Architect values were significantly lower (mean difference: -13 nmol/L; 95% limits: -54; 28 nmol/L) and the ELISA values were significantly higher (mean difference: 24 nmol/L; 95% limits: -36; 84 nmol/L) than the LC/MSIMS values. The slope of the Passing-Bablok regression line relative to LC/MSIMS was 0.5 [95% confidence interval (CI): 0.41; 0.60] and 1.17 (95% CI: 0.87; 1.56) for Architect and ELISA, respectively, with an intercept of approximately 16 for both assays. Using 50 nmol/L as the cut-point for deficiency, Architect and ELISA misclassified 20 and 27% of the subjects, respectively. In subjects with low circulating 25-hydroxylated ergocalciferol [25(OH)D2] (<10 nmol/L), a Bland-Altman plot and Kappa statistics (Kappa = 0.73; 95% CI: 0.49-0.97) showed good agreement between Architect and LC/MS/MS. However, in subjects with high circulating 25(OH)D2 (>or=10 nmol/L), Architect demonstrated poor agreement (Kappa = 0.40; 95% CI: 0.16-0.65). ELISA demonstrated a higher degree of overestimation in women with minimal 25(OH)D2 than those with high 25(OH)D2, suggesting that ELISA overestimates 25-hydroxylated cholecalciferol [25(OH)D3] but underestimates 25(OH)D2.
采用自动免疫分析法[Architect（雅培公司）]和酶联免疫吸附测定法（Alpco诊断公司）对74名肥胖女性的血清样本进行25-羟基维生素D[25(OH)D]浓度检测，并将结果与液相色谱/串联质谱参考方法（奎斯特诊断公司）进行比较。与液相色谱/串联质谱法的值相比，Architect法的值显著更低（平均差值：-13 nmol/L；95%界限：-54；28 nmol/L），酶联免疫吸附测定法的值显著更高（平均差值：24 nmol/L；95%界限：-36；84 nmol/L）。相对于液相色谱/串联质谱法，Architect法和酶联免疫吸附测定法的帕氏-巴布洛克回归线斜率分别为0.5[95%置信区间（CI）：0.41；0.60]和1.17（95%CI：0.87；1.56），两种检测方法的截距均约为16。以50 nmol/L作为缺乏的切点，Architect法和酶联免疫吸附测定法分别将20%和27%的受试者误分类。在循环中25-羟基麦角钙化醇[25(OH)D2]水平较低（<10 nmol/L）的受试者中，布兰德-奥特曼图和卡帕统计分析（卡帕=0.73；95%CI：0.49-0.97）显示Architect法和液相色谱/串联质谱法之间具有良好的一致性。然而，在循环中25(OH)D2水平较高（≥10 nmol/L）的受试者中，Architect法显示一致性较差（卡帕=0.40；95%CI：0.16-0.65）。酶联免疫吸附测定法在25(OH)D水平最低的女性中比在25(OH)D水平较高的女性中表现出更高程度的高估，这表明酶联免疫吸附测定法高估了25-羟基胆钙化醇[25(OH)D3]但低估了25(OH)D2。
