Clin Chem Lab Med. 2016 Jul 1;54(7):1211-9. doi: 10.1515/cclm-2015-0987.
Therapeutic drug monitoring (TDM) of infliximab (IFX, Remicade®) can aid to optimize therapy efficacy. Many assays are available for this purpose. However, a reference standard is lacking. Therefore, we evaluated the analytical performance, agreement and clinically relevant differences of three commercially available IFX ELISA kits on an automated processing system.
The kits of Theradiag (Lisa Tracker Infliximab), Progenika (Promonitor IFX) and apDia (Infliximab ELISA) were implemented on an automated processing system. Imprecision was determined by triplicate measurements of patient samples on five days. Agreement was evaluated by analysis of 30 patient samples and four spiked samples by the selected ELISA kits and the in-house IFX ELISA of Sanquin Diagnostics (Amsterdam, The Netherlands). Therapeutic consequences were evaluated by dividing patients into four treatment groups using cut-off levels of 1, 3 and 7 μg/mL and determining assay concordance.
Within-run and between-run imprecision were acceptable (≤12% and ≤17%, respectively) within the quantification range of the selected ELISA kits. The apDia assay had the best precision and agreement to target values. Statistically significant differences were found between all assays except between Sanquin Diagnostics and the Lisa Tracker assay. The Promonitor assay measured the lowest IFX concentrations, the apDia assay the highest. When patients were classified in four treatment categories, 70% concordance was achieved.
Although all assays are suitable for TDM, significant differences were observed in both imprecision and agreement. Therapeutic consequences were acceptable when patients were divided in treatment categories, but this could be improved by assay standardization.
英夫利昔单抗（IFX，类克）的治疗药物监测（TDM）有助于优化治疗效果。为此目的有许多检测方法，但缺乏参考标准。因此，我们评估了三种市售的 IFX ELISA 试剂盒在自动化处理系统上的分析性能、一致性和临床相关差异。
Theradiag（Lisa Tracker Infliximab）、Progenika（Promonitor IFX）和 apDia（Infliximab ELISA）试剂盒在自动化处理系统上实施。通过在五天内对患者样本进行三次重复测量来确定精密度。通过对 30 个患者样本和 4 个加标样本的分析，评估所选 ELISA 试剂盒与 Sanquin Diagnostics（荷兰阿姆斯特丹）的内部 IFX ELISA 的一致性。通过使用 1、3 和 7μg/mL 的截止值将患者分为四个治疗组，并确定检测方法的一致性，评估治疗结果。
在所选择的 ELISA 试剂盒的定量范围内，批内和批间精密度均在可接受范围内（分别为≤12%和≤17%）。apDia 检测法具有最佳的精密度和与靶值的一致性。除了 Sanquin Diagnostics 和 Lisa Tracker 检测法之间外，所有检测法之间均存在统计学显著差异。Promonitor 检测法测量的 IFX 浓度最低，apDia 检测法测量的 IFX 浓度最高。当将患者分为四个治疗类别时，有 70%的一致性。
尽管所有检测法都适用于 TDM，但在精密度和一致性方面均存在显著差异。当患者按治疗类别分组时，治疗结果可以接受，但通过检测方法标准化可以得到改善。
