4277 – AKLIDES® CytoBead® ANA 2

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 2 is intended as an aid in the diagnosis of systemic autoimmune diseases in conjunction with other clinical and laboratory findings.

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.

The Cytobead® is an innovative indirect immunofluorescence immunoassay for the determination of specific antibodies. Tissue sections or cells containing the antigen of interest as well as additional beads coated with specific antigens are immobilized on slides. If specific antibodies are present in the patient´s sample, they bind to the antigen. A secondary antibody conjugated with fluorescein-isothiocyanat (FITC) detects the generated immune complex. The slides are examined using a fluorescence microscope. A specific fluorescent staining pattern demonstrates the presence of specific antibodies in the patient´s sample.

The immunoassay is designed for manual processing and automated imaging using the AKLIDES® or akiron® system.

Worldwide first and fully automated system,  AKLIDES® digital fluorescence microscope is used for the standardized imaging and data processing in immunofluorescence tests on glass slides for the automated determination of ANA, ANCA, nDNA, analysis of microparticles (Cytobead®) and for documentation of tissue sections. Controlled by the AKLIDES® Software, the AKLIDES® system has the ability to produce valid standardized analyses and to document immunofluorescence assays electronically to augment daily laboratory routine in the diagnosis of autoimmune diseases.

The immunoassay is designed for professional in vitro diagnostic use only.