Optimization And Qualification Of The Single Molecule Array Digital Immunoassay For IL-12P70 In Plasma Of Cancer Patients
Vinita Gupta, Navdeep Kalia, Mahesh Yadav, Amy Noyes, Jeremy Good, Robert Hendricks & Wenfeng Xu
Bioanalysis. 2018 Sep 5
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.
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%.
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.
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