4063 – AKLIDES® ANA plus

The AKLIDES® ANA plus is an immunofluorescence assay (IFA) for the qualitative and semi-quantitative determination of IgG antibodies in human serum against nuclear and cytoplasmic antigens (ANA) on HEp-2 cells. The AKLIDES® ANA plus 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 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. The use of Hep-2 cells in immunofluorescence assay offers a very sensitive screening approach to detect antinuclear antibodies (ANA) directed against components of the cell nucleus. By identifying the staining patterns on HEp-2 cells, the identification of the antigen targeted by ANA and the associated autoimmune disorders is achieved

The IFA (indirect immunofluorescence assay) is an immuno-assay for the determination of specific antibodies. Tissue sections or cells containing the antigen of interest are immobilized on slides. If specific antibodies are present in the patient´s sample, they bind to the antigen in the tissue. 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 for imaging.

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.