4270 – AKLIDES® CytoBead® ANCA

Intended Purpose

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. The immunoassay is designed for manual processing and automated evaluation using the AKLIDES^® or akiron^® system. The immunoassay is designed for professional in vitro diagnostic use only.

Diagnostic Relevance

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.