Bioanalytical qualification of clinical biomarker assays in plasma using a novel multi-analyte Simple Plex platform

Bioanalysis. 2016 Dec;8(23):2415-2428. doi: 10.4155/bio-2016-0196.

Abstract

Aim: Immune-checkpoint inhibitors are presumed to break down the tolerogenic state of immune cells by activating T-lymphocytes that release cytokines and enhance effector cell function for elimination of tumors. Measurement of cytokines is being pursued for better understanding of the mechanism of action of immune-checkpoint inhibitors, as well as to identify potential predictive biomarkers.

Results: In this study, we show bioanalytical qualification of cytokine assays in plasma on a novel multi-analyte immunoassay platform, Simple Plex. The qualified assays exhibited excellent sensitivity as evidenced by measurement of all samples within the quantifiable range. The accuracy and precision were 80-120% and 10%, respectively.

Conclusion: The qualified assays will be useful in assessing mechanism of action cancer immunotherapies.

Keywords: PD-1; PD-L1; Simple Plex; T-cell activation markers; biomarkers; cytokines; immunoassay; multi-analyte; multiplex.

MeSH terms

  • Biomarkers / blood*
  • Blood Chemical Analysis / instrumentation*
  • Blood Chemical Analysis / methods*
  • Chemokines / blood
  • Cytokines / blood
  • Enzyme-Linked Immunosorbent Assay*
  • Humans
  • Reproducibility of Results
  • T-Lymphocytes / metabolism

Substances

  • Biomarkers
  • Chemokines
  • Cytokines