Systemic lupus erythematosus is a systemic autoimmune disease belonging to the collagenosis group. Diagnosis of SLE is base on the 11 ACR criteria (ACR = American College of Rheumatology) . If 4 of 11 criteria are present, the probability of SLE presence is between 80 and 90%. Antibodies against dsDNA are among the most important criteria of diagnosis of SLE due to their high specificity: 70% to 98% depending on the method of detection. Since the concentration of these antibodies correlates with the disease activity, particularly with the activity of lupus nephritis, titer deteminations are suitable for monitoring therapy.

Anti-dsDNA antibodies are found almost exclusively in systemic SLE, also known as lupus erythematosus disseminatus. The prevalence of antibodies against dsDNA amounts to 20% to 90% depending on the detection method and disease activity. Antibodies against dsDNA are also occasionally detected in patient with other autoimmune diseases and infection and in rare cases, in clinically healthy people. 85% of people in the latter group develop SLE within 5 years of initial detection of anti-dsDNA. However, SLE cannot be entirely excluded if anti-dsDNA antibodies are not detected.