Valor Lara, Hernández-Flórez Diana, de la Torre Inmaculada, Llinares Francisca, Rosas José, Yagüe Jordi, Garrido Jesús, Naredo Esperanza
Department of Rheumatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Laboratory Department, Hospital Marina Baixa, Villajoyosa, Alicante, Spain.
Clin Exp Rheumatol. 2015 Sep-Oct;33(5):617-23. Epub 2015 Aug 27.
Infliximab (IFX) and adalimumab (ADL) drug levels and anti-drug antibodies (ADA) are assessed using a variety of techniques, therefore, results cannot accurately be compared for clinical purposes. The aim of this study was to test two infliximab (IFX) and adalimumab (ADL) ELISA versions, for drug levels and ADA, to see whether they yield similar results.
ELISA versions [Promonitor® IFX R1 and R2 (V.1), Promonitor® IFX and Anti-IFX (V.2); Promonitor® ADL R1 and R2 (V.1), Promonitor® ADL and Anti-ADL (V.2) kits (Progenika Biopharma, Spain)] were used to measure drug levels and ADA in IFX (n=24) and ADL (n=24) rheumatoid arthritis-treated patients in three independent laboratories. Quantitative and qualitative agreements were evaluated using intraclass correlation coefficients (ICC), and Cohen's Kappa (κ) respectively. The Bland-Altman plots assessed differences between V.1 and V.2.
Interlaboratory agreement (ICC/κ) with V.1 was poor for IFX (0.66/0.62) and ADL (0.69/0.52) drug levels; meanwhile, high agreement was found with V.2 for IFX (0.98/0.95) and ADL (0.094/1.00). Comparison between V.1 and V.2 in each laboratory resulted in systematically higher values in V.2 than in V.1 and poor agreement (ICC/κ ranges) for IFX (0.12-0.7/ 0.19-0.42) and ADL (0.69-0.89 /0.50-0.73).
Qualitative measurements result in better agreement, as evidenced in our study. Greater agreement in V.2 compared with V.1 for IFX and ADL levels could be due to a better tune up. Further studies are required to standardise methods to establish therapeutic reference ranges.
英夫利昔单抗（IFX）和阿达木单抗（ADL）的药物水平及抗药物抗体（ADA）采用多种技术进行评估，因此，临床目的下的结果无法准确比较。本研究旨在测试两种用于检测英夫利昔单抗（IFX）和阿达木单抗（ADL）药物水平及ADA的酶联免疫吸附测定（ELISA）版本，以观察它们是否产生相似结果。
使用ELISA版本[Promonitor® IFX R1和R2（V.1）、Promonitor® IFX和抗IFX（V.2）；Promonitor® ADL R1和R2（V.1）、Promonitor® ADL和抗ADL（V.2）试剂盒（西班牙Progenika生物制药公司）]在三个独立实验室中测量接受IFX（n = 24）和ADL（n = 24）治疗的类风湿关节炎患者的药物水平及ADA。分别使用组内相关系数（ICC）和科恩kappa系数（κ）评估定量和定性一致性。布兰德 - 奥特曼图评估V.1和V.2之间的差异。
对于IFX（0.66/0.62）和ADL（0.69/0.52）药物水平，V.1的实验室间一致性较差；同时，对于IFX（0.98/0.95）和ADL（0.94/1.00），V.2显示出高度一致性。每个实验室中V.1和V.2的比较结果显示，V.2的值系统性地高于V.1，且IFX（0.12 - 0.7 / 0.19 - 0.42）和ADL（0.69 - 0.89 / 0.50 - 0.73）的一致性较差（ICC/κ范围）。
如本研究所示，定性测量结果的一致性更好。与V.1相比，V.2在IFX和ADL水平上具有更高的一致性，这可能是由于更好的校准。需要进一步研究以标准化方法来建立治疗参考范围。
