4028 – ANCA Dot

Intended Purpose

The ANCA Dot is a qualitative dot immunoassay for the determination of IgG antibodies against myeloperoxidase (MPO), proteinase 3 (PR3) and glomerular basement membrane (GBM) in human serum. The ANCA Dot 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 manual professional in vitro diagnostic use.

Diagnostic Relevance

Systemic vasculitis (SV) pathogenesis is majorly identified by the inflammation of different blood vessel walls, and the resulting morphological changes. Anti-neutrophil cytoplasmic antibodies (ANCA) play an essential role in the serological diagnosis of SV. These antibodies are usually determined by indirect immunofluorescence using ethanol fixed human neutrophils. Cytoplasmic ANCA (cANCA) and perinuclear ANCA (pANCA) are distinguished based on the immunofluorescence pattern.

Goodpasture syndrome, a medical emergency with a high fatality rate if not treated, is characterized by glomerulonephritis, pulmonary haemorrhage and antibody formation against glomerular basement membrane (GBM). The antibodies targeted against GBM component are the primary pathogenic autoantibodies, binding along the glomerular basement membrane and inducing glomerulonephritis in all patients with Goodpasture syndrome. Their determination allows differentiating the syndrome from other causes of glomerular nephritis and pulmonary haemorrhage.

Product Specifications

Title ANCA Dot
Product code 4028
Indication Systemic vasculitis and autoimmune renal disorders
Description Dot Immunoassay for the qualitative determination of IgG antibodies against Myeloperoxidase (MPO), Proteinase 3 (PR3) and Glomerular Basement Membrane (GBM) in human serum
Antigens Myeloperoxidase (MPO), proteinase 3 (PR3) and glomerular basement membrane protein (GBM)
Total incubation time 80 min.
Sample volume 10 µL serum
No. of determinations 24 x 3

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  SDS [REF 4028][eng]   SDS [REF 4028][deu]

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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.