5033 – Anti-dsDNA

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

The appearance of autoantibodies directed against components of the cell nucleus are characteristic features of systemic autoimmune diseases, especially systemic lupus erythematosus (SLE), Sjögren’s syndrome, progressive systemic sclerosis (PSS), mixed connective tissue disease (MCTD), rheumatoid arthritis (RA) and dermatomyositis. The detection of autoantibodies in patient sample e.g. plasma and serum, is well established and plays an essential role in the diagnosis of systemic autoimmune diseases. The American College of Rheumatology for SLE identifies antibodies to dsDNA as the hallmark for SLE diagnostics. Generic Assays offers a complete range of serological markers for systemic autoimmune diseases. All assays employ the same scheme and pre-dilution, maximizing laboratory efficiency.

Product Specifications

Title Anti-dsDNA
Product code 5033
Indication Systemic lupus erythematosus
Description Enzyme immunoassay for the quantitative determination of IgG antibodies against dsDNA in human serum
Format Microtiter plate coated with with purified dsDNA
Total incubation time 105 min.
Sample volume 10 µL serum
No. of determinations 96 (90 x 1) + 5 x Calibrators + 1 x Control

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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.