Abstract

Abstract The SomaScan™ assay is a highly multiplexed proteomic assay that uses SOMAmer™ reagents to detect proteins in various biological samples. The latest version of the SomaScan assay allows researchers to measure over 11,000 proteins in human blood. The SomaScan assay is designed to provide protein epitope abundance measurements by reporting relative SOMAmer reagent abundance quantified using DNA microarrays. This is common for highly multiplexed proteomic assays but different from clinical protein assays, which report protein concentrations. We set out to develop a Quantitative Immunology Protein Panel (QuIPP) built on the SomaScan 7K assay, focused on a set of 58 immunologically-relevant cytokines, chemokines, and growth factors. Panel qualification was performed by developing calibration curves and demonstrating reproducibility for the biomarker measurements in serum samples with defined LLOQ and ULOQ acceptance criteria. Intra-run and inter-run CVs were calculated for high, medium, and low QC samples. 54 analytes met the standard curve, QC sample reproducibility, and plate edge effect acceptance criteria, with 34 analytes meeting strict parallelism acceptance criteria. We have demonstrated the process for developing the QuIPP using SomaScan assay as a core technology. The ability to generate quantitative results will allow SomaScan users to compare protein concentrations across datasets and further validate biomarker discoveries on the SomaScan platform.

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