Enzyme immunoassay for the qualitative and quantitative determination of IgG antibodies against double stranded (ds)DNA in human serum. Systemic lupus erythematosus (SLE) is an autoimmune-mediated, chronic inflammatory illness with variable clinical presentation, ranging from localised skin lesions to a destructive systemic disorder without cutaneous changes. Antibodies to double-stranded (ds)DNA are a well-known, specific marker for SLE with a prevalence from 50-90%, depending on disease severity. Their titre often correlates with disease activity and provides a tool for therapy control. Circulating DNA/anti-DNA immune complexes are considered to play a role in the pathogenesis of SLE. dsDNA-antibodies constitute a SLE criterion according to the American Rheumatism Association (ARA).