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Analytical and clinical performance evaluation of two POC tests for therapeutic drug monitoring of infliximab

  • Dorien Van den Bossche EMAIL logo , Dieter De Smet , Johan Debrabandere and Hilde Vanpoucke
Published/Copyright: December 18, 2018
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 57 Issue 6

Abstract

Background

Infliximab (IFX) is an effective therapy in patients with inflammatory bowel disease. Serum IFX trough concentrations correlate well with clinical, biological and endoscopic outcomes. Therefore, therapeutic drug monitoring (TDM) of infliximab is useful for dose optimization and prevention of secondary treatment failure. In the present study, analytical and clinical performance of two point-of-care (POC) tests, RIDA®QUICK IFX Monitoring assay (R-biopharm) and Quantum Blue® Infliximab assay (Bühlmann), have been evaluated and compared to our established enzyme-linked immunosorbent assay (ELISA) (apDia IFX ELISA).

Methods

Analytical performance was assessed according to the CLSI EP5-A2 protocol using the manufacturer’s kit controls and different serial dilution series. Method comparison with our established ELISA was done using a wide range of consecutive patient samples (n=180). Clinical concordance was evaluated by categorization based on well-known therapeutic cut-off points (3–7 μg/mL).

Results

The analytical performance of both POC tests was inferior to the established ELISA, but acceptable based on the manufacturer’s quality claims. Eight-point serial dilution confirmed the analytical performance data in the low-level measuring range. Eleven-point serial dilution demonstrated linearity for both POC tests over the studied concentration range. Method comparison with the ELISA showed significant negative proportional bias for the RIDA®QUICK IFX Monitoring assay. However, good correlation and clinical concordance were shown. Quantum Blue® Infliximab assay showed a significant positive proportional and a negative systematic bias in comparison with the ELISA, resulting in overestimation of IFX levels with impact on clinical concordance data.

Conclusions

Both POC tests have their own specific benefits and drawbacks but are suitable for therapeutic drug monitoring of IFX. However, long-term monitoring of IFX trough levels requires measurement of IFX concentrations with the same assay.

Keywords: enzyme-linked immunosorbent assay; infliximab; point-of-care; therapeutic drug monitoring; tumor necrosis factor-α; trough concentration

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

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) 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: 2018-08-16
Accepted: 2018-11-15
Published Online: 2018-12-18
Published in Print: 2019-05-27

©2019 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2018-0891
Keywords for this article
enzyme-linked immunosorbent assay; infliximab; point-of-care; therapeutic drug monitoring; tumor necrosis factor-α; trough concentration

Articles in the same Issue

  1. Frontmatter
  2. Obituary
  3. Professor Howard A. Morris
  4. Editorial
  5. The silk road to total quality in Laboratory Medicine
  6. Reviews
  7. Moving average quality control: principles, practical application and future perspectives
  8. Serum α-fetoprotein in pediatric oncology: not a children’s tale
  9. Mini Review
  10. Value-based healthcare: the role of laboratory medicine
  11. Opinion Paper
  12. Advantages and limitations of total laboratory automation: a personal overview
  13. General Clinical Chemistry and Laboratory Medicine
  14. Analysis and evaluation of the external quality assessment results of quality indicators in laboratory medicine all over China from 2015 to 2018
  15. A pilot study for establishing quality indicators in molecular diagnostics according to the IFCC WG-LEPS initiative: preliminary findings in China
  16. Quality assessment of interpretative commenting and competency comparison of comment providers in China
  17. Lower creatinine concentration values and lower inter-laboratory variation among Swedish hospital laboratories in 2014 compared to 1996: results from the Equalis external quality assessment program
  18. Development of the Point-of-Care Key Evidence Tool (POCKET): a checklist for multi-dimensional evidence generation in point-of-care tests
  19. Analytical and clinical performance evaluation of two POC tests for therapeutic drug monitoring of infliximab
  20. Hematology and Coagulation
  21. Provisional standardization of hepcidin assays: creating a traceability chain with a primary reference material, candidate reference method and a commutable secondary reference material
  22. Danger of false negative (exclusion) or false positive (diagnosis) for ‘congenital thrombophilia’ in the age of anticoagulants
  23. Point-of-care haemostasis monitoring during liver transplantation is cost effective
  24. Reference Values and Biological Variations
  25. Evaluation of reference intervals of haematological and biochemical markers in an Austrian adolescent study cohort
  26. Cancer Diagnostics
  27. A novel machine learning-derived decision tree including uPA/PAI-1 for breast cancer care
  28. Cardiovascular Diseases
  29. Evaluation of analytical performances using standardized analytical protocols and comparison of clinical results of the new ADVIA BNP and NT-proBNP immunoassays for the Centaur XPT platform
  30. Infectious Diseases
  31. Improvement in detecting sepsis using leukocyte cell population data (CPD)
  32. Letters to the Editor
  33. The biological variation of plasma proenkephalin: data from a stable heart failure cohort
  34. Hemoglobin variants found in relation to HbA1c testing: high occurrence of Hb Athens-Georgia in the Northern Jutland, Denmark
  35. Eltrombopag interferes with the measurement of plasma total bilirubin in pediatric patients in an automated colorimetric method
  36. A challenging case: highly variable TSH in a mother and her two children
  37. Suppressing all test results in grossly hemolyzed samples: is this approach appropriate in every case?
  38. Prozone effect observed for heavy chain α in the serum immunofixation electrophoresis of a patient with monoclonal IgA-λ gammopathy
  39. Significant allelic dropout phenomenon of Oncomine BRCA Research Assay on Ion Torrent S5
  40. Evaluation of immature platelet fraction in patients with myelodysplastic syndromes. Association with poor prognosis factors
  41. Influence of temperature of transport of whole blood on plasma Cu, I, Mn, Se and Zn and Mg concentrations in erythrocytes
  42. Absorbent materials to collect urine can affect proteomics and metabolomic biomarker concentrations
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