4281 – AKLIDES® CytoBead® RPGN

Intended Purpose

The AKLIDES^® CytoBead^® RPGN 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), glomerular basal membrane (GBM) and double stranded deoxyribonucleic acid (dsDNA). The  AKLIDES^® CytoBead^® RPGN is intended as an aid in the 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 imaging using the AKLIDES^® or akiron^® system. The immunoassay is designed for professional in vitro diagnostic use only.

Diagnostic Relevance

The detection of antibodies against neutrophil cytoplasmic antigens (ANCA), the glomerular basement membrane (GBM) and double stranded deoxyribonucleic acid (dsDNA) is used for the differential diagnosis of ANCA associated vasculitis (AAV) and systemic vasculitis (Granulomatosis with Polyangiitis – GPA, Microscopic Polyangiitis – MPA, Eosinophilic Granulomatosis with Polyangiitis – EGPA). It is also employed for the diagnosis of autoimmune kidney diseases (Good pasture syndrome, Rapidly Progressive Glomerulonephritis – RPGN and SLE associated nephritis).