4291 – ANA 18 LINE

Highlights

• Determination of IgG antibodies against 18 nuclear and cytoplasmic antigens
• LINE immunoblot for simultaneous multi-antigen testing
• Quality assured handling in routine laboratories
• Ready-to-use test strips with positive, negative, and conjugate controls
• Provides clear visual results using an interpretation template
• Aids in the diagnosis of systemic autoimmune and inflammatory rheumatic diseases
• Parallel detection of DFS70 antibodies enables differentiation of positive IFA patterns without clinical relevance
• Automated
• CE marked

Intended Use

The ANA 18 LINE is a qualitative LINE immunoblot for the determination of IgG antibodies against nuclear and cytoplasmic antigens (dsDNA, nucleosome, Sm, Sm/RNP, ribosomes, histone, U1-snRNP, SS-A/Ro60, SS-A/Ro52, SS-B, Scl-70, PM/Scl, CENP-A/B, PCNA, Jo-1, M2, DFS70 and F-actin) in human serum. The ANA 18 LINE is intended as an aid in the diagnosis of systemic inflammatory rheumatic diseases in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

The detection of antibodies in patient samples is well established and plays an essential role in the diagnosis of systemic autoimmune diseases. The appearance of antibodies 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. Parallel detection of DFS70 antibodies allows differentiation of positive immunofluorescence assay (IFA) patterns on HEp-2 cells that do not have clinical relevance for rheumatic diseases, enhancing diagnostic accuracy and confidence.