Optimization and qualification of the single molecule array digital immunoassay for IL-12p70 in plasma of cancer patients.

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.

• Authors: Vinita Gupta, Navdeep Kalia, Mahesh Yadav, Amy Noyes, Jeremy Good, Robert Hendricks, Wenfeng Xu
• Journal: Bioanalysis (Bioanalysis) Vol. 10 Issue 17 Pg. 1413-1425 (Sep 01 2018) ISSN: 1757-6199 [Electronic] England
• PMID: 30182727 (Publication Type: Journal Article)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Interleukin-12
• atezolizumab

Topics

• Antibodies, Monoclonal (pharmacology)
• Antibodies, Monoclonal, Humanized
• Blood Chemical Analysis (methods)
• Humans
• Immunoassay (methods)
• Interleukin-12 (blood)
• Limit of Detection
• Neoplasms (blood)