Home Medicine Comparative evaluation of the My5-FU™ immunoassay and LC-MS/MS in monitoring the 5-fluorouracil plasma levels in cancer patients
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Comparative evaluation of the My5-FU™ immunoassay and LC-MS/MS in monitoring the 5-fluorouracil plasma levels in cancer patients

  • Barbara Büchel , Johanna Sistonen , Markus Joerger , Yolanda Aebi , Stefan Schürch and Carlo R. Largiadèr EMAIL logo
Published/Copyright: February 14, 2013
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 51 Issue 8

Abstract

Background: Chemotherapies of solid tumors commonly include 5-fluorouracil (5-FU). With standard doses of 5-FU, substantial inter-patient variability has been observed in exposure levels and treatment response. Recently, improved outcomes in colorectal cancer patients due to pharmacokinetically guided 5-FU dosing were reported. We aimed at establishing a rapid and sensitive method for monitoring 5-FU plasma levels in cancer patients in our routine clinical practice.

Methods: Performance of the Saladax My5-FU™ immunoassay was evaluated on the Roche Cobas® Integra 800 analyzer. Subsequently, 5-FU concentrations of 247 clinical plasma samples obtained with this assay were compared to the results obtained by liquid chromatography-tandem mass spectrometry (LC-MS/MS) and other commonly used clinical analyzers (Olympus AU400, Roche Cobas c6000, and Thermo Fisher CDx90).

Results: The My-FU assay was successfully validated on the Cobas Integra 800 analyzer in terms of linearity, precision, accuracy, recovery, interference, sample carryover, and dilution integrity. Method comparison between the Cobas Integra 800 and LC-MS/MS revealed a proportional bias of 7% towards higher values measured with the My5-FU assay. However, when the Cobas Integra 800 was compared to three other clinical analyzers in addition to LC-MS/MS including 50 samples representing the typical clinical range of 5-FU plasma concentrations, only a small proportional bias (≤1.6%) and a constant bias below the limit of detection was observed.

Conclusions: The My5-FU assay demonstrated robust and highly comparable performance on different analyzers. Therefore, the assay is suitable for monitoring 5-FU plasma levels in routine clinical practice and may contribute to improved efficacy and safety of commonly used 5-FU-based chemotherapies.

Keywords: Cobas Integra 800; 5-fluorouracil; method comparison; My5-FU; therapeutic drug monitoring
Corresponding author: Carlo R. Largiadèr, Institute of Clinical Chemistry, Inselspital, Bern University Hospital, and University of Bern, INO-F, 3010 Bern, Switzerland, Phone: +41 31 632 95 45, Fax: +41 31 632 48 62

The My5-FU assay reagents, calibrators, pooled plasma samples for validation, 50 clinical plasma samples, and data for a subset of samples (AU400, CDx90, Cobas c6000) for method comparison were kindly provided by Saladax Biomedical. We thank J. Dias and U. Sonnenschein for their support in the My5-FU assay evaluation and P. Rhyn and C. Bühr for their expertise and help with the LC-MS/MS analyses.

Conflict of interest statement

Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article. Research support played no role in the analysis and interpretation of data, in the writing of the report or in the decision to submit the report for publication.

Research funding: Financial support for this study was provided by a research grant from the Swiss National Science Foundation (31003A_138285) to Carlo R. Largiadèr.

Employment or leadership: None declared.

Honorarium: None declared.

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Received: 2012-09-21
Accepted: 2013-01-21
Published Online: 2013-02-14
Published in Print: 2013-08-01

©2013 by Walter de Gruyter Berlin Boston

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https://doi.org/10.1515/cclm-2012-0641
Keywords for this article
Cobas Integra 800; 5-fluorouracil; method comparison; My5-FU; therapeutic drug monitoring

Articles in the same Issue

  1. Letters to the Editors
  2. Clinical utility of serum tumor markers and cytokines in cervical cancer and neoplasia
  3. Establishing reference intervals for LDL subfractions in a Korean population using the Lipoprint LDL system
  4. Measurement imprecision of common urinary biochemical analytes on the Roche Cobas 6000 system
  5. A comparison between turbidimetric inhibition immunoassay and capillary electrophoresis in glycated hemoglobin (HbA1c) measurement
  6. Commutability: a peculiar property of calibration and control materials. Definition and evaluation
  7. Diagnostic sensitivity of a panel of tests to detect monoclonal protein in Korean multiple myeloma patients
  8. Commutability of proficiency testing (PT): status of the matrix-related bias in general clinical chemistry
  9. Masthead
  10. Masthead
  11. Editorial
  12. Why specifications for allowable glucose meter errors should include 100% of the data
  13. Reviews
  14. ABO blood group: old dogma, new perspectives
  15. Trace elements and bone health
  16. Mini Review
  17. The role of transcription factors in laboratory medicine
  18. Opinion Papers
  19. Nobelitis: a common disease among Nobel laureates?
  20. The syndrome of the “obsessive-compulsory scientist”: a new mental disorder?
  21. Can current analytical quality performance of UK clinical laboratories support evidence-based guidelines for diabetes and ischaemic heart disease? – A pilot study and a proposal
  22. Guidelines and Recommendations
  23. Survey of national guidelines, education and training on phlebotomy in 28 European countries: an original report by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PA)
  24. General Clinical Chemistry and Laboratory Medicine
  25. Red cell indices: differentiation between β-thalassemia trait and iron deficiency anemia and application to sickle cell disease and sickle cell thalassemia
  26. Problems in determining thalassemia carrier status in a program for prevention and control of severe thalassemia syndromes: a lesson from Thailand
  27. An enzyme linked immunosorbent assay (ELISA) for the determination of the human haptoglobin phenotype
  28. Blood loss from laboratory diagnostic tests in children
  29. Hematocrit correction does not improve glucose monitor accuracy in the assessment of neonatal hypoglycemia
  30. Evaluation of a mobile clinical pathology laboratory developed for the home care of pediatric patients following transplantation of peripheral blood precursor cells
  31. Folic acid supplementation does not reduce intracellular homocysteine, and may disturb intracellular one-carbon metabolism
  32. Influence of spurious hemolysis on blood gas analysis
  33. Serum procalcitonin predicts development of acute kidney injury in patients with suspected infection
  34. Reference Values and Biological Variations
  35. Nationwide multicenter study aimed at the establishment of common reference intervals for standardized clinical laboratory tests in Japan
  36. Cancer Diagnostics
  37. Application of BRAF, NRAS, KRAS mutations as markers for the detection of papillary thyroid cancer from FNAB specimens by pyrosequencing analysis
  38. Comparative evaluation of the My5-FU™ immunoassay and LC-MS/MS in monitoring the 5-fluorouracil plasma levels in cancer patients
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