Rocha Cátia, Afonso Joana, Lago Paula, Arroja Bruno, Vieira Ana I, Dias Claudia C, Magro Fernando
Department of Biomedicine, University of Porto, Porto, Portugal University of Lisbon, Faculty of Medicine, Instituto de Sáude Ambiental, Lisbon, Portugal.
Department of Biomedicine, University of Porto, Porto, Portugal Centre for Drug Discovery and Innovative Medicines, University of Porto, Porto, Portugal.
Therap Adv Gastroenterol. 2019 Feb 27;12:1756284819828238. doi: 10.1177/1756284819828238. eCollection 2019.
The loss of response to adalimumab (ADL) has been related to low serum concentrations at trough. Currently, most methods commercially available for the quantification of ADL are enzyme-linked immunosorbent assay (ELISA) based, with a turnaround time of approximately 8 h, delaying the target dosage adjustment to the subsequent infusion. In this study, we aimed to evaluate the performance of the newly available rapid-test ADL quantification assay by comparing it with three established ELISA methods, using spiked samples and a set of clinical samples.
Spiked samples from control donors and 120 serum samples from inflammatory bowel disease (IBD) patients undergoing ADL therapy were quantified using lateral flow Quantum Blue Adalimumab and, the ELISA formats from Immundiagnostik, R-Biopharm and an in-house assay.
The rapid-test assay had intraclass correlation coefficients of 0.590, 0.864 and 0.761 when comparing with the Immundiagnostik, R-Biopharm and in-house assays, respectively. For the five therapeutic windows, the accuracy was high: ADL rapid test compared with the Immundiagnostik (58-88%); R-Biopharm, 68-89%; and in house, 60-88%; and kappa statistics revealed 0.492-0.602, 0.531-0.659 and 0.545-0.682, respectively.
The Quantum Blue Adalimumab assay can replace the commonly used ELISA-based ADL quantification kits and it is a reliable alternative to these methods. This rapid-test assay enables the quantitative determination of ADL serum trough level in only 15 min. The developed assay allows measurement of ADL over a wide range. Hence, it represents a valuable tool for the clinician to assess the ADL trough level.
对阿达木单抗（ADL）反应丧失与谷浓度时血清浓度低有关。目前，市面上大多数用于定量ADL的方法都是基于酶联免疫吸附测定（ELISA），周转时间约为8小时，这延迟了对后续输注的目标剂量调整。在本研究中，我们旨在通过将新可用的快速检测ADL定量测定法与三种既定的ELISA方法进行比较，使用加标样本和一组临床样本，来评估其性能。
使用侧向流动量子蓝阿达木单抗以及Immundiagnostik、R-Biopharm的ELISA方法和一种内部测定法，对来自对照供体的加标样本和120例接受ADL治疗的炎症性肠病（IBD）患者的血清样本进行定量。
与Immundiagnostik、R-Biopharm和内部测定法相比，快速检测测定法的组内相关系数分别为0.590、0.864和0.761。对于五个治疗窗，准确性较高：ADL快速检测与Immundiagnostik相比为58 - 88%；R-Biopharm为68 - 89%；内部测定法为60 - 88%；kappa统计分别显示为0.492 - 0.602、0.531 - 0.659和0.545 - 0.682。
量子蓝阿达木单抗测定法可替代常用的基于ELISA的ADL定量试剂盒，是这些方法的可靠替代方法。这种快速检测测定法仅需15分钟就能定量测定ADL血清谷浓度。所开发的测定法能够在很宽的范围内测量ADL。因此，它是临床医生评估ADL谷浓度的有价值工具。
