Development and validation of an enzyme-linked immunosorbent assay to measure adalimumab concentration

Bioanalysis. 2015;7(10):1253-60. doi: 10.4155/bio.15.30.


Background: Adalimumab is a therapeutic antibody used for treating inflammatory diseases. To understand interindividual PK variability, there is a need to develop and validate an assay to measure serum adalimumab concentrations.

Methods: An ELISA was developed on microtiter plates coated with TNF-α. Seven nonzero adalimumab standards ranging from 0.05 to 50 mg/l and three quality controls (0.2, 2.5 and 7 mg/l) were tested for their intra and interday precision on six occasions.

Results: The LOD, LLOQ and ULOQ of the assay were 0.022, 0.073 and 9 mg/l, respectively.

Conclusion: This method is accurate, reproducible and may be useful for PK studies and for therapeutic drug monitoring of adalimumab.

Publication types

  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Adalimumab / blood*
  • Anti-Inflammatory Agents / blood*
  • Drug Monitoring / methods*
  • Enzyme-Linked Immunosorbent Assay / methods*
  • Humans
  • Limit of Detection
  • Reproducibility of Results


  • Anti-Inflammatory Agents
  • Adalimumab