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Clinical Chemistry and Laboratory Medicine (CCLM)

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Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


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

Emilio J. Laserna-Mendieta
  • Corresponding author
  • Department of Gastroenterology, Hospital General de Tomelloso, Tomelloso, Spain
  • Clinical Laboratory, Hospital General de Villarrobledo, Villarrobledo, Spain
  • Email
  • Other articles by this author:
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/ Sara Salvador-Martín
  • Department of Pharmacy, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain
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  • De Gruyter OnlineGoogle Scholar
/ Laura Arias-González / Miriam Ruiz-Ponce / Luis A. Menchén
  • Department of Gastroenterology, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain
  • Biomedical Research Network Center for Liver and Digestive Diseases (CIBEREHD), Madrid, Spain
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ César Sánchez
  • Department of Gastroenterology, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain
  • Universidad Complutense de Madrid, Department of Medicine, Madrid, Spain
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  • De Gruyter OnlineGoogle Scholar
/ Luis A. López-Fernández
  • Department of Pharmacy, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain
  • Spanish Clinical Research Network (SCReN), Madrid, Spain
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Alfredo J. Lucendo
  • Department of Gastroenterology, Hospital General de Tomelloso, Tomelloso, Spain
  • Biomedical Research Network Center for Liver and Digestive Diseases (CIBEREHD), Madrid, Spain
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Published Online: 2019-05-14 | DOI: https://doi.org/10.1515/cclm-2019-0202

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.

Keywords: adalimumab; drug monitoring; ELISA; inflammatory bowel diseases; point-of-care testing

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About the article

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


Received: 2019-01-29

Accepted: 2019-03-29

Published Online: 2019-05-14


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

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.

Employment or leadership: None declared.

Honorarium: None declared.

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.


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), 20190202, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2019-0202.

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