Division of Clinical Biochemistry, Department of Laboratory Medicine, Dr. Everett Chalmers Regional Hospital, Horizon Health Network, Fredericton, New Brunswick, Canada E3B 5N5.
Clin Biochem. 2012 Nov;45(16-17):1485-90. doi: 10.1016/j.clinbiochem.2012.06.002. Epub 2012 Jun 13.
To evaluate the newly developed Roche MODULAR Analytics E170 Total Vitamin D and the Siemens ADVIA Centaur Vitamin D Total assays.
Assays were evaluated using the Clinical and Laboratory Standards Institute protocols. Split patient samples were compared with LC-MS/MS and DiaSorin LIAISON assays (n=79 including 15 specimens with detectable endogenous 25-OH vitamin D(2)). Assay accuracy was also evaluated using the Vitamin D External Quality Assessment Scheme (DEQAS) samples.
The ADVIA Centaur and E170 assays demonstrated maximum total CVs of 14.1% and 5.9%, respectively. Both showed excellent linearity (R(2)>0.99). The ADVIA Centaur assay demonstrated interference with bilirubin at 800 μmol/L, hemolysis at 1.25 g/L, and triglycerides at 2.8 mmol/L. Compared to LC-MS/MS, the ADVIA Centaur assay demonstrated a R(2) value of 0.893, average bias of -8.8%; the E170 assay an R(2) value of 0.872, average bias of 14.3% with underestimation of 25-OH vitamin D(2). Compared to the LIAISON assay, the ADVIA Centaur assay demonstrated an R(2) value of 0.781, average bias of -17.3%; the E170 assay an R(2) value of 0.823, average bias of 11.4%. The ADVIA Centaur and E170 assays demonstrated a biases of <20% in 10/10 and 8/10 DEQAS samples, respectively.
The ADVIA Centaur and E170 vitamin D assays demonstrated acceptable linearity, imprecision, and accuracy. The E170 assay demonstrated consistent underestimation of 25-OH vitamin D(2) levels. Compared with LC-MS/MS, the ADVIA Centaur assay demonstrated a higher R(2) value and a smaller average bias than the E170 assay.
评估罗氏 MODULAR Analytics E170 总维生素 D 和西门子 ADVIA Centaur 总维生素 D 检测试剂盒。
使用临床和实验室标准协会（CLSI）方案评估检测试剂盒。对患者样本进行拆分并与 LC-MS/MS 和 DiaSorin LIAISON 检测试剂盒进行比较（n=79，包括 15 份可检测到内源性 25-羟维生素 D(2)的样本）。还使用维生素 D 外部质量评估计划（DEQAS）样本评估检测试剂盒的准确性。
ADVIA Centaur 和 E170 检测试剂盒的总最大 CV 分别为 14.1%和 5.9%。两种检测试剂盒均表现出优异的线性（R(2)>0.99）。ADVIA Centaur 检测试剂盒在胆红素 800 μmol/L、血红蛋白 1.25 g/L 和甘油三酯 2.8 mmol/L 时存在干扰。与 LC-MS/MS 相比，ADVIA Centaur 检测试剂盒的 R(2)值为 0.893，平均偏差为-8.8%；E170 检测试剂盒的 R(2)值为 0.872，平均偏差为 14.3%，25-羟维生素 D(2)检测值偏低。与 LIAISON 检测试剂盒相比，ADVIA Centaur 检测试剂盒的 R(2)值为 0.781，平均偏差为-17.3%；E170 检测试剂盒的 R(2)值为 0.823，平均偏差为 11.4%。ADVIA Centaur 和 E170 检测试剂盒在 10/10 和 8/10 的 DEQAS 样本中，偏差均<20%。
ADVIA Centaur 和 E170 维生素 D 检测试剂盒具有良好的线性、不精密度和准确性。E170 检测试剂盒对 25-羟维生素 D(2)水平的检测结果持续偏低。与 LC-MS/MS 相比，ADVIA Centaur 检测试剂盒的 R(2)值高于 E170 检测试剂盒，平均偏差也更小。
