Development of NULISAseq™ 250-Plex Inflammation Panel for Immune Profiling of Autoimmune Diseases

Abstract Comprehensive profiling of cytokines and chemokines in blood can provide deeper insights into the mechanisms underlying this highly complex and heterogeneous group of diseases. However, many of these proteins are present at very low concentrations in plasma, below the limit of detection of current immunoassays. We recently developed a novel automated multiplex immunoassay technology, NULISA™, capable of attomolar-level sensitivity and high levels of multiplexing. Here we report the development of a 250-plex inflammation-focused panel targeting a broad range of cytokines/chemokines and other important inflammation and immune response-related proteins. We conducted a pilot study to assess the utility of this panel for autoimmune disease research. We analyzed plasma samples from patients with rheumatoid arthritis (RA), Sjögren's syndrome (SjS), systemic lupus erythematosus (SLE), and ulcerative colitis (UC), and compared to healthy donors. Linear model analysis identified differentially abundant proteins associated with diseases including many low-abundance targets with important roles in autoimmune diseases, such as IL4, IL5, IL20, IL17A, IL17F, IL33, and IL2RB. In summary, with the ultrahigh sensitivity and the most comprehensive inflammatory cytokine/chemokine panel, the NULISA™ Platform promises to be a powerful discovery tool for autoimmune disease research, which may lead to new diagnostic biomarkers and therapeutic targets.