4277 – AKLIDES® CytoBead® ANA 2

Intended Purpose

The AKLIDES^® CytoBead^® ANA 2 is an immunofluorescence assay (IFA) for the semi-quantitative determination of IgG antibodies against nuclear and cytoplasmic antigens (ANA) and quantitative determination of IgG antibodies against dsDNA, Scl-70, SS-A/Ro60, SS-A/Ro52, SS-B, Jo-1, Sm and Sm/RNP in human serum. The AKLIDES^® CytoBead^® 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 manual processing and automated imaging using the AKLIDES^® or akiron^® system. The immunoassay is designed for professional in vitro diagnostic use only.

Diagnostic Relevance

The appearance of autoantibodies directed against components of the cell nucleus are characteristic features of systemic autoimmune diseases, especially; SLE, Sjögren’s syndrome, progressive systemic sclerosis (PSS), mixed connective tissue disease (MCTD), rheumatoid arthritis (RA) and dermatomyositis. The detection of auto-antibodies in patient sample, e.g. plasma and serum, is well established and plays an essential role in the diagnosis of systemic autoimmune diseases. Determination of these autoantibodies using AKLIDES® CytoBead® ANA 2 indirect immunofluorescence on fixated HEp-2 cells allows further ANA differentiation of relevant antigens via multiplex bead technology in one well.