5069 – DotDiver Scleroderma 10

Highlights

• Qualitative dot immunoassay for the detection of IgG antibodies against nuclear and cytoplasmic antigens
• Supports the diagnosis of systemic sclerosis and CREST syndrome
• Detects Scl-70, CENP-A, CENP-B, PM/Scl-100, PM/Scl-75, Ku, RNA polymerase III, RNP (68kDa/A/C), Fibrillarin and Th/To antibodies
• Enables simultaneous multi-antigen testing on a single strip
• Semi-automated processing with the DotDiver instrument
• Ready-to-use breakable test strips with integrated positive and negative controls
• Highly purified antigens for reliable and specific antibody detection
• Enzyme-based color development for clear visual interpretation
• Designed for professional in vitro diagnostic use
• CE marked

Intended Use

The DotDiver Scleroderma 10 is a qualitative dot immunoassay for the determination of IgG antibodies against nuclear and cytoplasmic antigens (Scl-70, CENP-A, CENP-B, PM/Scl-100, PM/Scl-75, Ku, RNA Polymerase III, RNP (68kD/A/C), Fibrillarin and Th/To) in human serum. The DotDiver Scleroderma 10 is intended as an aid in the diagnosis of scleroderma diseases in conjunction with other clinical and laboratory findings. The immunoassay is designed for semi-automated use with the DotDiver instrument. The immunoassay is designed for professional in vitro diagnostic use.

Diagnostic Relevance

Progressive systemic sclerosis (PSS), also known as systemic scleroderma, occurs when the immune system attacks connective tissue, causing fibrosis that gradually thickens and hardens the skin. The disease can also affect internal organs, including the heart, lungs, and kidneys. In CREST syndrome, a limited form of scleroderma, patients produce autoantibodies against centromere proteins (CENP) and often show clinical features such as calcinosis, Raynaud’s phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia.

In indirect immunofluorescence assays, patients with scleroderma often exhibit positive nucleolar staining caused by autoantibodies to fibrillarin, PM/Scl, or RNA polymerases. These autoantibodies are highly specific markers for scleroderma and provide valuable information for distinguishing between limited and diffuse forms of the disease. Early and accurate detection of these antibodies supports timely diagnosis, risk assessment, and monitoring of disease progression, enabling clinicians to implement appropriate therapeutic interventions and manage potential complications effectively.