Systemic sclerosis (SSc; also termed scleroderma) is a rare, complex, multi-organ autoimmune disease which manifests as progressive fibrosis of the skin and internal organs and has a high unmet diagnostic need. The disease is associated with the presence of several specific autoantibodies to intracellular targets and the three most frequently observed autoantibodies are only present in about 60-70% of SSc patient’s, anti-topoisomerase I (anti-Scl70), anti-centromere (ACA) and anti-RNA polymerase III (ARA). As autoantibody specificities are strongly associated with patterns of organ involvement and disease outcome, understanding their mechanisms are an essential tool in the clinical management of SSc.
Using its SeroTag® platform Protagen has focused on the identification of a new class of biomarkers for SSC to augment current diagnostic tools. Extensive research revealed several novel SSc-associated antigens. The first of which, BICD2, is now available as a CE-Mark assay and adds to our portfolio of CE-Mark assays, Scl-70 and CENP-B, two standard markers used in the diagnosis of SSc. Together this panel of IVD assays can provide significant improvements to current diagnostic tests with the ability to better distinguish between different forms of the disease.
All our assays are set-up with the user in mind and follow these principles:
Simple Integration and set-up
• Color coded reagents
• Reagents ready to use (except washing buffer)
• Break apart microtiter strips
• Short assay time: < 1.5 h at RT (30 min /30 min /15 min)
• Detection system: HRP/TMB (OD450 nm)
• Low detection limit
• Highly specific discrimination between SSc patients and controls
• Excellent lot to lot correlation
• Low intra- and inter-assay variation
• Excellent linearity