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Accuracy of the new rapid test for monitoring adalimumab levels.
- Source :
-
Therapeutic advances in gastroenterology [Therap Adv Gastroenterol] 2019 Feb 27; Vol. 12, pp. 1756284819828238. Date of Electronic Publication: 2019 Feb 27 (Print Publication: 2019). - Publication Year :
- 2019
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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.<br />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 <superscript>®</superscript> Adalimumab and, the ELISA formats from Immundiagnostik, R-Biopharm and an in-house assay.<br />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.<br />Conclusions: The Quantum Blue <superscript>®</superscript> 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.<br />Competing Interests: Conflict of interest statement: FM served as speaker and received honoraria from Merck Sharp & Dohme, Abbvie, Vifor, Falk, Laboratorios Vitoria, Ferring, Hospira and Biogen.
Details
- Language :
- English
- ISSN :
- 1756-283X
- Volume :
- 12
- Database :
- MEDLINE
- Journal :
- Therapeutic advances in gastroenterology
- Publication Type :
- Academic Journal
- Accession number :
- 30833984
- Full Text :
- https://doi.org/10.1177/1756284819828238