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Therapeutic drug monitoring of infliximab: performance evaluation of three commercial ELISA kits

  • Ellen M.H. Schmitz , Daan van de Kerkhof , Dörte Hamann , Joost L.J. van Dongen , Philip H.M. Kuijper , Luc Brunsveld , Volkher Scharnhorst and Maarten A.C. Broeren EMAIL logo
Published/Copyright: November 20, 2015
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 54 Issue 7

Abstract

Background: Therapeutic drug monitoring (TDM) of infliximab (IFX, Remicade®) can aid to optimize therapy efficacy. Many assays are available for this purpose. However, a reference standard is lacking. Therefore, we evaluated the analytical performance, agreement and clinically relevant differences of three commercially available IFX ELISA kits on an automated processing system.

Methods: The kits of Theradiag (Lisa Tracker Infliximab), Progenika (Promonitor IFX) and apDia (Infliximab ELISA) were implemented on an automated processing system. Imprecision was determined by triplicate measurements of patient samples on five days. Agreement was evaluated by analysis of 30 patient samples and four spiked samples by the selected ELISA kits and the in-house IFX ELISA of Sanquin Diagnostics (Amsterdam, The Netherlands). Therapeutic consequences were evaluated by dividing patients into four treatment groups using cut-off levels of 1, 3 and 7 μg/mL and determining assay concordance.

Results: Within-run and between-run imprecision were acceptable (≤12% and ≤17%, respectively) within the quantification range of the selected ELISA kits. The apDia assay had the best precision and agreement to target values. Statistically significant differences were found between all assays except between Sanquin Diagnostics and the Lisa Tracker assay. The Promonitor assay measured the lowest IFX concentrations, the apDia assay the highest. When patients were classified in four treatment categories, 70% concordance was achieved.

Conclusions: Although all assays are suitable for TDM, significant differences were observed in both imprecision and agreement. Therapeutic consequences were acceptable when patients were divided in treatment categories, but this could be improved by assay standardization.

Keywords: assay comparison; ELISA; Infliximab; therapeutic drug monitoring
Corresponding author: Maarten A.C. Broeren, Klinisch chemisch laboratorium, Máxima Medisch Centrum Veldhoven, Postbus 7777, 5500 MB Veldhoven, The Netherlands, E-mail: ; Expert Center Clinical Chemistry Eindhoven, Eindhoven, The Netherlands; and Máxima Medical Center Veldhoven, Clinical Laboratory, Veldhoven, The Netherlands

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Supplemental Material:

The online version of this article (DOI: 10.1515/cclm-2015-0987) offers supplementary material, available to authorized users.

Received: 2015-10-9
Accepted: 2015-10-19
Published Online: 2015-11-20
Published in Print: 2016-7-1

©2016 by De Gruyter

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https://doi.org/10.1515/cclm-2015-0987
Keywords for this article
assay comparison; ELISA; Infliximab; therapeutic drug monitoring

Articles in the same Issue

  1. Frontmatter
  2. In Memoriam: Gérard Siest (1936–2016)
  3. Editorials
  4. Improving diagnosis and reducing diagnostic errors: the next frontier of laboratory medicine
  5. The quality indicator paradox
  6. Review
  7. Clinical utility of the (-2)proPSA and evaluation of the evidence: a systematic review
  8. Mini Review
  9. Why are clinical practice guidelines not followed?
  10. EFLM Position Paper
  11. Patient identification and tube labelling – a call for harmonisation
  12. Genetics and Molecular Diagnostics
  13. A fast and simple method for detecting and quantifying donor-derived cell-free DNA in sera of solid organ transplant recipients as a biomarker for graft function
  14. Performance of two commercially available BCR-ABL1 quantification assays that use an international reporting scale
  15. HAND1 loss-of-function mutation associated with familial dilated cardiomyopathy
  16. General Clinical Chemistry and Laboratory Medicine
  17. Performance criteria and quality indicators for the post-analytical phase
  18. Assessing the commutability of reference material formats for the harmonization of amyloid-β measurements
  19. Quantitative determination of four immunosuppressants by high resolution mass spectrometry (HRMS)
  20. Measurement of plasma vitamin K1 (phylloquinone) and K2 (menaquinones-4 and -7) using HPLC-tandem mass spectrometry
  21. Therapeutic drug monitoring of infliximab: performance evaluation of three commercial ELISA kits
  22. High level of oxysterols in neonatal cholestasis: a pitfall in analysis of biochemical markers for Niemann-Pick type C disease
  23. Reference Values and Biological Variations
  24. Reference intervals of plasma homoarginine from the German Gutenberg Health Study
  25. TSH and fT4 during pregnancy: an observational study and a review of the literature
  26. Cancer Diagnostics
  27. Mean corpuscular volume levels and all-cause and liver cancer mortality
  28. Cardiovascular Diseases
  29. Circulating endothelial-derived apoptotic microparticles and insulin resistance in non-diabetic patients with chronic heart failure
  30. Hematology and Coagulation
  31. Platelet aggregation in response to ADP is highly variable in normal donors and patients on anti-platelet medication
  32. Letters to the Editor
  33. EQA-derived metrics to assess overall instrument performance
  34. Misidentification in laboratory medicine and diagnostic process: a neglected problem calling for action
  35. Impact of the routine implementation of automated indirect immunofluorescence antinuclear antibody analysis: 1 year of experience
  36. The importance of angiogenic markers in the differential diagnosis of HELLP syndrome vs. non-HELLP thrombocytopenia
  37. Bisalbuminemia accompanying bisalbuminuria detected in capillary electrophoresis, not in gel electrophoresis
  38. Prognostic value of red blood cell distribution width in acute pancreatitis patients admitted to intensive care units: an analysis of a publicly accessible clinical database MIMIC II
  39. Differences in analytical and biological results between older and newer lots of a widely used irisin immunoassay question the validity of previous studies
  40. A diagnostic algorithm for the detection of inhibitors against coagulation Factor V
  41. Interference of anticoagulants on coagulation testing
  42. Congress Abstracts
  43. Swiss MedLab 2016 and 74th Annual Meeting of the Swiss Society of Microbiology SSM, Bern, 13–16 June 2016
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