5020 – DotDiver Quantrix ANA

Intended Purpose

The DotDiver Quantrix ANA is a quantitative dot immunoassay for the determination of IgG antibodies against nuclear and cytoplasmic antigens (nucleosomes, dsDNA, histones, Sm, RNP, Sm/RNP, SS-A/Ro60, SS-A/Ro52, SS-B, Scl-70, Ku, PM/Scl-100, Mi-2, Jo-1, PL-7, PL-12, SRP, ribosomes, CENP-A/B, PCNA, sp100, gp210, M2 recombinant, M2/nPDC and f-actin) in human serum. The DotDiver Quantrix ANA is intended as an aid in the diagnosis of systemic autoimmune 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

The appearance of autoantibodies directed against components of the cell nucleus is a characteristic feature 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 anti-nuclear autoantibodies (ANA) in patient sample, e.g. plasma and serum, is well established and plays an essential role in the diagnosis of systemic autoimmune diseases.