4270 – AKLIDES® CytoBead® ANCA

The AKLIDES® CytoBead® ANCA is an immunofluorescence assay (IFA) for the semi-quantitative determination of IgG antibodies in human serum against neutrophil cytoplasmic antigens (ANCA), and quantitative determination of IgG antibodies against proteinase 3 (PR3), myeloperoxidase (MPO) and glomerular basal membrane (GBM). The AKLIDES® CytoBead® ANCA is intended as an aid in the diagnosis of systemic vasculitis as well as autoimmune renal disorders in conjunction with other clinical and laboratory findings.

Determination of IgG autoantibodies (AAb) in human serum specific for Proteinase 3 (PR3), Myeloperoxidase (MPO) as well as glomerular basement membrane (GBM) is done with the help of PR3, MPO or GBM coated beads. Ethanol fixed human granulocytes in the same well allow the determination of the fluorescence pattern, cytoplasmic (cANCA) or perinuclear (pANCA). Using the automated platform technology AKLIDES®, the fluorescence intensity of the cells and the antigen-coated beads is determined and the fluorescence pattern cANCA and pANCA on the granulocytes are differentiated. Standard curves (IU/ml for PR3 and MPO, and U/ml for GBM) help to quantify the amount of specific antibodies in the serum in specific units.

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 evaluation 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.