Towards standardization of immune functional assays

Clin Immunol. 2020 Jan:210:108312. doi: 10.1016/j.clim.2019.108312. Epub 2019 Nov 21.


Recent advances in the immunotherapy field require evaluation of the immune function to adapt therapeutic decisions. Immune functional assays (IFA) are able to reveal the immune status and would be useful to further adapt and/or improve patient's care. However, standardized methods are needed to implement IFA in clinical settings. We carried out an independent validation of a published method used to characterize the underlying host response to infectious conditions using an IFA. We evaluated the reproducibility and robustness of this IFA and the associated readout using an independent healthy volunteers (HV) cohort. Expression of a 44-gene signature and IFNγ protein secretion was assessed after stimulation. We observed a strong host-response correlation between the two cohorts. We also highlight that standardized methods for immune function evaluation exist and could be implemented in larger-scale studies. This IFA could be a relevant tool to reveal innate and adaptive immune dysfunction in immune-related disorders patients.

Keywords: Host response; Immune functional assay; Independent validation; Standardization; Stimulation.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adaptive Immunity
  • Adult
  • Aged
  • Cells, Cultured
  • Cohort Studies
  • Female
  • Healthy Volunteers
  • Humans
  • Immunoassay / standards*
  • Interferon-gamma / metabolism*
  • Male
  • Middle Aged
  • Reference Standards*
  • Reproducibility of Results
  • Transcriptome / immunology


  • Interferon-gamma