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Licensed Unlicensed Requires Authentication Published by De Gruyter May 14, 2019

Comparison of a new rapid method for the determination of adalimumab serum levels with two established ELISA kits

Emilio J. Laserna-Mendieta, Sara Salvador-Martín, Laura Arias-González, Miriam Ruiz-Ponce, Luis A. Menchén, César Sánchez, Luis A. López-Fernández and Alfredo J. Lucendo

Abstract

Background

Therapeutic drug monitoring (TDM) of adalimumab (ADA) in inflammatory bowel diseases (IBDs) has gained increased attention since several studies showed a correlation between drug levels and mucosal healing. The limitations of routine usage of enzyme-linked immunoabsorbent assay (ELISA) kits for measuring serum ADA concentrations have prompted the development of rapid methods, such as Quantum Blue (QB). We evaluated the interchangeability and agreement between the QB method and two established ELISA kits, Promonitor (PM) and Lisa-Tracker (LT).

Methods

Fifty samples from patients with IBD were included. Quantitative analysis was performed using the ANOVA test for repeated measures, Deming regression and the Bland-Altman plot. Clinical implications were evaluated by concordance in classifying patients into therapeutic windows according to the proposed cut-off levels for subtherapeutic (either <5 or <7.5 μg/mL) and supratherapeutic (>12 μg/mL) ranges.

Results

Statistical differences were detected between the QB method and the two ELISA kits, with QB overestimating ADA serum values compared to them. A lack of interchangeability was observed between methods, with greater differences as ADA levels increased. An analysis of a sub-set of samples with ADA values below 9 μg/mL (n = 25) showed that QB fulfilled the criteria to be interchangeable with the LT assay. Concordance for patient classification into ADA therapeutic windows was better for QB vs. LT than for QB vs. PM, with high agreement (>75%) for subtherapeutic levels among the three methods.

Conclusions

Although quantitative differences existed between the rapid method and ELISA kits that hampered their interchangeability, the agreement for identifying patients with subtherapeutic values of ADA was high.


Corresponding author: Emilio J. Laserna-Mendieta, EuSpLM, PhD, Department of Gastroenterology, Hospital General de Tomelloso, Véreda de Socuéllamos, s/n, Tomelloso (Ciudad Real) 13700, Spain; and Clinical Laboratory, Hospital General de Villarrobledo, Villarrobledo, Spain

Acknowledgments

We are grateful to Melanie Radcliff for English language revision. EJ Laserna-Mendieta is recipient of a Rio Hortega grant (CM17/00003) from Instituto de Salud Carlos III (ISCIII), Spanish Ministry of Health, Social Services and Equality, which is partly funded by the European Social Fund (period 2014–2020). Sara Salvador-Martín was supported by a predoctoral fellowship from the Gregorio Marañón Health Research Institute. Laura Arias González is recipient of a post-doctoral research grant from Fundación Hospital Nacional de Parapléjicos (II-2018_05). Luis A. Menchén was supported by a grant (PI16/02096) from the Ministry of Economy and Competitiveness ISCIII-FIS. Luis A. López-Fernández was supported by a grant (PI16/00559) from the Ministry of Economy and Competitiveness ISCIII-FIS and PEJ16/MED/AI-1260 from the Consejería de Educación y Deporte de la Comunidad de Madrid. All funding from ISCIII was co-funded by European Regional Development Funds from the European Commission, “A way of making Europe”.

  1. Author contribution: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: No specific funding was used to carry out this study. Palex Medical has generously provided half of the determinations performed in the present study for Quantum Blue ADA and Lisa-Tracker ADA.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interest: The funding organization played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Received: 2019-01-29
Accepted: 2019-03-29
Published Online: 2019-05-14
Published in Print: 2019-11-26

©2019 Walter de Gruyter GmbH, Berlin/Boston

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