Comparative study of two techniques of mycophenolate mofetyl monitoring

Tunis Med. 2019 Aug-Sep;97(8-9):1010-1016.

Abstract

Introduction: Mycophenolic acid (MPA) requires routine therapeutic drug monitoring.

Aim: To evaluate the suitability of a MPA Immunoassay CEDIA performed on Indiko® analyzer (Thermo fisher) for monitoring of MPA by comparing values obtained by HPLC-UV method.

Methods: This study was carried out on 114 blood samples collected from renal transplant, using high performance liquid chromatography combined with ultraviolet detection (HPLC-UV, reference method) and the new immunoassay on CEDIA.

Results: The assay was linear for a mycophenolic acid concentration up to 10 μg/mL. When MPA concentrations in all 114 transplant recipients obtained by the HPLC-UV (x-axis) method were compared with corresponding values obtained by the CEDIA® method (y-axis), the following regression equation was obtained: CEDIA® = 1.558 HPLC + 0.49 (r = 0.86). However more significant positive bias was observed (37 %).

Conclusion: The data presented suggest that the CEDIA® MPA immunoassay, run on the Indiko® analyzer, over-estimates plasma MPA concentrations. However, CEDIA® immunoassay is less laborious and time consuming than chromatographia techniques.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Biomarkers, Pharmacological / analysis
  • Biomarkers, Pharmacological / blood
  • Blood Chemical Analysis / methods*
  • Chromatography, High Pressure Liquid / methods
  • Drug Monitoring / methods*
  • Humans
  • Immunoassay / methods
  • Immunosuppressive Agents / therapeutic use
  • Kidney Transplantation
  • Mycophenolic Acid / therapeutic use*
  • Reproducibility of Results

Substances

  • Biomarkers, Pharmacological
  • Immunosuppressive Agents
  • Mycophenolic Acid