BIOANALYSIS

Vinita Gupta, Navdeep Kalia, Mahesh Yadav, Amy Noyes, Jeremy Good, Robert Hendricks & Wenfeng Xu

Bioanalysis. 2018 Sep 5

DOI: https://doi.org/10.4155/bio-2018-0083

Abstract

Aim: 

Cytokine/chemokine levels can reflect the pharmacodynamics of checkpoint inhibitors. The single molecule array (Simoa) HD-1 is a sensitive next-generation immunoassay platform for quantification of low abundance proteins, with potential for cancer immunotherapy mechanism of action studies. 

Results: 

The Simoa IL-12p70 reagents, standard curve and test conditions were optimized for improved precision and linearity of dilution in plasma of cancer patients. The assay achieved a lower limit of quantification of 0.08 pg/ml, with 27/29 samples recording above lower limit of quantification, precision ≤20% CV and accuracy within 80–120%. 

Conclusion:

Simoa enabled quantification of IL-12p70 at sub-pg/ml levels in cancer patients and was superior to Simple-Plex and Aushon in overall performance. This study qualifies the user-modified IL-12p70 immunoassay to measure pharmacodynamic changes in plasma during cancer immunotherapy.