ANCA Screen ELISA

Enzyme immunoassay for the qualitative measurement of IgG class autoantibodies against PR3 and MPO in human serum or plasma.

INTENDED USE:ANCA Screen is is an ELISA test system for the qualitative measurement of IgG class autoantibodies against PR3 and MPO in human serum or plasma. This product is intended for professional in vitro diagnostic use only. Anti-neutrophil cytoplasmic antibodies (ANCA) against proteinase 3 (PR3) or myeloperoxidase (MPO) are diagnostic markers for ANCA-associated vasculitides. PR3 is the landmark antigen in granulomatosis with polyangiitis (GPA, formerly Wegener's granulomatosis). MPO differentiates microscopic polyangiitis (MPA) and eosinophilic granulomatosis with polyangiitis (EGPA). The test supports the differential diagnosis of these diseases when used in combination with other laboratory and clinical findings.

GENERAL INFORMATION:A mixture of purified antigens PR3 and MPO is coated on to microwells. The determination is based on an indirect enzyme linked immune reaction with the following steps: Specific antibodies in the patient sample bind to the antigen coated on the surface of the reaction wells. After incubation, a washing step removes unbound and unspecifically bound serum or plasma components. Subsequently added enzyme conjugate binds to the immobilized antibody-antigencomplexes. After incubation, a second washing step removes unbound enzyme conjugate. After addition of substrate solution the bound enzyme conjugate hydrolyses the substrate forming a blue coloured product. Addition of an acid stops the reaction generating a yellow end-product. The intensity of the yellow color correlates with the concentration of the antibody-antigen-complex and can be measured photometrically at 450 nm.

KIT CHARACTERISTICS:
- Method: ELISA
- 96 tests
- Incubation Time / Conditions: 30, 15, 15, 5 min (RT)
- Standard Range: Cut-off
- Sensitivity analytical: diagn. 95.1 %
- Final Sample Volume: 100 µl
- Sample Type: serum, plasma
- Sample Pretreatment: 1:100 diluted
- Isotope / Substrate: TMB 450 nm
- Regulatory Status: CE