The Protagen® Multilisa® Scl-70 is a CE-approved IVD ELISA for the semi-quantitative determination of anti-Scl-70 autoantibodies in human serum and plasma. The assay is used to aid the diagnosis of Systemic Sclerosis (SSc) together with additional laboratory tests and clinical findings.
Scl-70 – a fundamental biomarker for SSc diagnosis
Scl-70 (Topoisomerase 1) is a nuclear and nucleolar enzyme. Circulating IgG autoantibodies targeted against Scl-70) are considered as being highly specific for the diagnosis of SSc. Scl-70 occur in 20-40 % of SSc patients and are highly prevalent in patients with a diffuse form of SSc, mostly accompanied by an increased risk of pulmonary fibrosis and digital ischemia (or digital ulcerations, DU). The existence of Scl-70 is highly specific, and therefore were included in the ACR EULAR classification criteria for the diagnosis of SSc. Protagen’s Multilisa Scl-70 has been developed to be used alongside other assays such as Multilisa CENP-B and BICD2, to provide a more complete diagnostic picture for SSc patients and their clinicians.
Application of Scl-70 to a CE-approved IVD assay
The new Multilisa® Scl-70 assay has received CE certification and is a market-ready IVD product available for purchase within the EU. If you would like to place an order or gather further information on Multilisa® Scl-70 please contact our team by filling in the form on the right.