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Project

Development and validation of an assay to quantify anti-dsDNA antibody levels and avidity for more accurate diagnosis and monitoring of SLE (ANTI DS DNA)

Systemic lupus erythematosus (SLE) is a heterogeneous and chronic multisystem autoimmune disease that mainly affects women between puberty and menopause. Typical in these patients is the presence of circulating anti-dsDNA and other anti-nuclear autoantibodies, which serve as serological markers for SLE diagnosis. Anti-dsDNA autoantibodies are the most important biomarkers as their concentration is directly linked to disease activity. The ideal test for antidsDNA autoantibody measurement should be able to distinguish high versus low avidity antidsDNA antibodies, since low avidity antibodies are also present in healthy individuals and in other (auto)immune diseases. Assays to detect anti-dsDNA antibodies include the Crithidia luciliae assay, the Farr radioimmunoassay (RIA) and solid-phase immunoassays (e.g. ELISA). Farr-RIA has the highest specificity, but is not automated and requires radio-active material for detection of antidsDNA autoantibodies and is thus destined to disappear in the clinical laboratories. ELISA is the most commonly used test, but has a low specificity regarding SLE diagnosis as it also detects low avidity anti-dsDNA antibodies. The low specificity of ELISA in SLE diagnosis is not commonly known, resulting in high numbers of SLE misdiagnoses and these patients consequently incorrectly treated with harmful therapies. Additionally, due to the heterogeneity and rarity of SLE, many patients are diagnosed late, causing irreversible organ damage and increased morbidity in the patients. Therefore, this project aims to develop and validate an Evalution®-based method for reliable, easy and safe measurement of the high avidity anti-dsDNA autoantibodies to guide SLE diagnosis and treatment.

We aim to provide an Evalution® test for measuring anti-dsDNA antibodies (level and avidity) for SLE diagnosis and disease monitoring. To achieve the general goal, several milestones need to be reached: WP1: Development of the Evalution® dsDNA test WP2: Technical validation of the Evalution® dsDNA test WP3: Clinical validation of the newly developed Evalution® dsDNA test by running a retrospective and a non-interventional multicenter prospective study. WP4: Online education platform to better inform healthcare professionals and patients.
 

Date:1 Oct 2019 →  30 Sep 2023
Keywords:Systemic lupus erythematosus (SLE), anti-dsDNA
Disciplines:Autoimmunity