Bioanalytical qualification of clinical biomarker assays in plasma using a novel multi-analyte Simple Plex™ platform. (December 2016)

• Record Type: Journal Article
• Authors: Gupta, Vinita; Davancaze, Teresa; Good, Jeremy; Kalia, Navdeep; Anderson, Michael; Wallin, Jeffrey J; Brady, Ann; Song, An; Xu, Wenfeng
• Is Part Of: Bioanalysis. Volume 8:Number 23(2016)
• Page Start: 2415
• Page End: 2428
• Publication Date: 2016-12
• Subjects: biomarkers -- cytokines -- immunoassay -- multi-analyte -- multiplex -- PD-1 -- PD-L1 -- Simple Plex -- T-cell activation markers; Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio-2016-0196
• Languages: English
• ISSNs: 1757-6180

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.