Intended use:
SeraSpot® Vaskulitis-3 IgG is an in vitro diagnostic device (spotimmunoassay, SIA) for the detection of autoantibodies of the IgG isotype directed against the following antigens: Proteinase 3 (PR3), myeloperoxidase (MPO) and glomerular basement membrane (GBM) in human serum or plasma samples.
General information:
Primary systemic vasculitis of small and middle large vessels (1) of unknown ethiopathogenesis is associated with anti-neutrophil cytoplasmic antibodies (ANCA). Because ANCA seem to activate directly neutrophil granulocytes which are accumulated in the lesions of small vessels and thereby initiate an inflammatory destructive process no immunoglobulins or complement components are seen in the vascular lesions (so-called “pauci-immune” vasculitis) (2, 3).
Major antigens of ANCA are: MPO,PR§, GBM all detectable with SeraSpot® Vaskulitis-3 IgG.
Test principle:
SeraSpot® Vaskulitis-3 IgG SIA is a solid phase immunoassay based on the use of recombinant or purified native proteins as capture antigens printed in array arrangement (spot array) on the bottom of the wells of 96well-microtitration plates. The antigens serve as capture molecules for autoantibodies against proteinase 3, myeloperoxidase and glomerular basement membrane. Bound antibodies are detected by horseradish peroxidase-(HRP)-labeled antibodies against human antibodies of IgG-type by substrate reaction with hydrogen peroxide and 3,3’,5,5’-tetramethylbenzidine (TMB). At the site of formed immune complexes blue spots are developed by precipitated product from colorless substrate solution.
Color intensity is correlated to the antibody concentration. Pale blue to dark blue spots are visible by eye.
Art. No.:
- SP-003-3 G-S6 (1×48)
| Art. No. | SP-003-3 G-S6 |
|---|---|
| Test format | Microspot array |
| Incubation time | 1.5 h |
Dear customers,
we have started to provide the documents for our products in an electronic format. These are the Instructions for Use (IFU), the Safety Data Sheets (SDS) and the Certificate of Analysis (CoA). For batches placed on the market after 01 January 2023, you can find our documents on the eIFU portal eifu.r-biopharm.com/clinic.
