4015 – Anti-dsDNA

Highlights

• Use of purified double-stranded DNA
• Ready-to-use (exception: wash buffer) and barcoded reagents
• Quality assured handling in routine laboratories
• Short incubation times (60 min / 30 min / 15 min) at room temperature
• Quantitative determination of IgG antibodies
• Calibrated with the international reference preparation WO/80
• Results expressed in IU/mL
• Excellent diagnostic sensitivity and specificity
• High precision within the measurement range
• CE marked
• Automatable

Intended Purpose

The Anti-dsDNA is a quantitative immunoassay for the determination of IgG antibodies against double-stranded desoxyribonucleic acid (dsDNA) in human serum. The Anti-dsDNA is intended as an aid in the diagnosis of systemic lupus erythematosus (SLE) in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Systemic lupus erythematosus (SLE) is an autoimmune disease that manifests with the formation of anti-nuclear antibodies (ANA), especially antibodies against double-stranded deoxyribonucleic acid (dsDNA). The disease is rare. Women get sick much more often than men. Depending on which organs or organ systems are affected, systemic lupus erythematosus manifests with different symptoms, which usually occur in phases and can also change over the course of the disease. Butterfly erythema occurs in a large number of patients and spreads symmetrically from the bridge of the nose to the cheeks. General symptoms such as tiredness and fever are also described. Kidney involvement, joint inflammation and other clinical manifestations are also often observed.

The diagnosis is made on the basis of the clinical symptoms and laboratory medical examinations. Laboratory examinations are based in particular on the detection of anti-nuclear antibodies (ANA). Antibodies against double-stranded deoxyribonucleic acid (dsDNA) are pathognomonic for systemic lupus erythematosus (SLE). They occur in about 65 % of patients and, along with antibodies against Smith antigen (Sm) and against phospholipids, are part of the classification criteria of American and European rheumatologists (ACR: American College of Rheumatology, EULAR: European League Against Rheumatism).