5018 – DotDiver ANCA

Intended Purpose

The DotDiver ANCA is a qualitative dot immunoassay for the determination of IgG antibodies against Myeloperoxidase (MPO), Proteinase 3 (PR3) and Glomerular Basement Membrane Protein (GBM) in human serum. The DotDiver ANCA is intended as an aid in the diagnosis of systemic vasculitis and autoimmune renal disorders in conjunction with other clinical and laboratory findings. The immunoassay is designed for semi-automated use with the DotDiver instrument. The immunoassay is designed for professional in vitro diagnostic use.

Diagnostic Relevance

Anti-neutrophil cytoplasmic antibodies (ANCA), a group of autoantibodies directed against cytoplasmic components of neutrophilic granulocytes, are associated with inflammatory vascular diseases. Some examples are systemic vasculitis (SV) pathogenesis, majorly identified by the inflammation of different blood vessel walls, and Goodpasture syndrome, an autoimmune kidney disorder, characterized by the coexistence of proliferative glomerulonephritis with lung haemorrhage and the formation of anti-GBM antibodies. Detection of the pathogenic circulating autoantibodies to GBM is a key diagnostic parameter of Goodpasture syndrome. Rapid progressive glomerulonephritis (RPGN) is a common feature of many autoimmune disorders. Differential diagnosis of autoimmune nephritides requires the determination of antibodies to GBM together with the determination of antibodies to neutrophilic cytoplasmic antigens (ANCA, characteristic for Wegener’s disease and vasculitis-associated RPGN), and nuclear antibodies (ANA, characteristic for lupus nephritis).