8063 – CytoBead® ANCA
The CytoBead® ANCA is an immunofluorescence assay (IFA) for the qualitative and semi-quantitative determination of IgG antibodies in human serum against neutrophil cytoplasmic antigens (ANCA) and the glomerular basal membrane (GBM). The CytoBead® ANCA is 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.
The appearance of autoantibodies directed against components of the cell nucleus are characteristic features 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 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. Cytobead ANCA is used for the differential diagnosis of ANCA associated vasculitis and systemic vasculitis (Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Eosinophilic Granulomatosis with Polyangiitis) as well as autoimmune renal disorders (Goodpasture-syndrome).
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 professional in vitro diagnostic use.
|Indication||Systemic vasculitis and autoimmune renal disorders|
|Description||Indirect immunofluorescence assay for the determination of IgG antibodies in human serum against neutrophil cytoplasmic antigens (ANCA) and the glomerular basement membrane (GBM)|
|Format||Slides coated with ethanol fixed human granulocytes as well as with beads coated with proteinase 3 (PR3), myeloperoxidase (MPO) and glomerular basement membrane (GBM|
|Total incubation time||60 min.|
|Sample volume||10 µL serum|
|No. of determinations||48 (6 x 8)|