5018 – DotDiver ANCA

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.

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).

Dot immunoassays are frequently used for the determination of specific antibodies directed against multiple antigens. The test strips are coated with various antigens in consistent intervals. If antibodies are present in the patient´s sample, they bind to the respective antigens. A secondary antibody conjugated with the enzyme alkaline phosphatase detects the generated immune complexes. A colorless substrate is converted into a colored, insoluble product. The signal intensity of the precipitated reaction product is proportional to the antibody activity in the sample.

The DotDiver ANCA is designed for semi-automated use with the DotDiver instrument.

The GA Generic Assays DotDiver2.0 is a fully automated processor of Line and Dot immunoassays. The small footprint renders the device an ideal solution for laboratories with small space. With a unique software design, the device provides a completely hands-free experience for quantitative, semi-quantitative and qualitative testing via repeated diving of the antigen coated strips into the ready to use cartridges. This special setup provides an optimal reaction environment with reduced assay processing and result analysis time for up to 24 different tests or samples simultaneously.