Accuracy of the new rapid test for monitoring adalimumab levels

Cátia Rocha; Joana Afonso; Paula Lago; Bruno Arroja; Ana I Vieira; Claudia C Dias; Fernando Magro

doi:10.1177/1756284819828238

Accuracy of the new rapid test for monitoring adalimumab levels

Therap Adv Gastroenterol. 2019 Feb 27:12:1756284819828238. doi: 10.1177/1756284819828238. eCollection 2019.

Authors

Cátia Rocha¹, Joana Afonso², Paula Lago³, Bruno Arroja⁴, Ana I Vieira⁵, Claudia C Dias⁶, Fernando Magro⁷

Affiliations

¹ Department of Biomedicine, University of Porto, Porto, Portugal University of Lisbon, Faculty of Medicine, Instituto de Sáude Ambiental, Lisbon, Portugal.
² Department of Biomedicine, University of Porto, Porto, Portugal Centre for Drug Discovery and Innovative Medicines, University of Porto, Porto, Portugal.
³ Gastroenterology Department, Centro Hospitalar São João, Porto.
⁴ Gastroenterology Department, Hospital de Braga, Braga, Portugal.
⁵ Gastroenterology Department, Hospital Garcia de Orta, Almada, Portugal.
⁶ Health Information and Decision Sciences Department, University of Porto, Porto, Portugal Centre for Health Technology and Services Research, University of Porto, Porto, Portugal.
⁷ Department of Biomedicine, Unit of Pharmacology and Therapeutics, Faculty of Medicine, University of Porto, Alameda Prof. Hernâni Monteiro, 4200-319 Porto, Portugal.

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: Quantum Blue® Adalimumab; adalimumab; therapeutic drug monitoring.