dsDNA-Ab RIA

dsDNA-Ab RIA  is now available as IVDR product!*

Intended Purpose

Radio immunoassay for the quantitative determination of antibodies against double-stranded DNA (dsDNA) in adult human serum. The device is intended as an aid in the diagnosis of SLE in patients suspected of Systemic lupus erythematosus (SLE) disease, a systemic and clinically heterogeneous autoimmune disease characterized by autoantibody formation. The presence of anti-dsDNA-Ab is highly characteristic for patients with SLE. It is intended as an aid in the diagnosis of SLE, as well as for antibody quantification before and during disease and as a followup/monitoring e.g. of treatments and disease progression. The test kit is intended for manual and professional laboratory use by trained personnel. The test kit is not for home or layperson use.

Clinical Significance

Systemic lupus erythematosus (SLE) is classified among the diseases of the collagenosis. It is a systemic and clinically heterogeneous autoimmune disease characterized by autoantibody formation. The disease can affect almost any part of the body and is characterized by remission and relapses. It is mostly affecting women of reproductive age (women are ten times more affected than men) but can be present at any age and gender. [1-4] Anti-nuclear antibodies (ANA), a heterogeneous group of autoantibodies to nuclear antigens in human serum or plasma, are frequently tested as a screening tool in patients with suspected systemic lupus erythematosus (SLE) or other connective tissue diseases. Anti-double-stranded DNA antibodies (anti-dsDNA) are part of antibodies detected by ANA and are commonly tested in SLE. ANA and anti-dsDNA are two well established criteria for classification of SLE. [5,6] Analysis of antibodies against double-stranded (ds) DNA is an important diagnostic tool for determination of SLE, and changes in anti-dsDNA antibody levels are also used to assess disease activity. [7,8] Several factors can influence the formation and amount of dsDNA autoantibodies in SLE patients. These include smoking, vitamin D deficiency, hormone therapy, but also past viral or bacterial infections as well as environmental influences or drugs. The patient's history must be taken into account for a detailed analysis of the development of the antibodies. Farr-RIA assay detects high-avidity antibodies quantitatively. This assay has the best correlation with disease activity and the highest specificity for lupus compared to other methods. The Farr assay is considered as the ‘gold standard’ for clinicians as so far it is the most specific assay for positive diagnosis of SLE and discrimination between other autoimmune diseases [1,9,10]

* Product availability and regulatory status may vary across regions outside the EU depending on local country-specific registration. Consult with your Tecan associate for further information.