Intended use:
The SeraSpot® ANA-17 IgG is an in vitro diagnostic device for the detection of antinuclear (ANA) and cytoplasmic antibodies of the IgG isotype directed against the following antigens: dsDNA, Nucleosomes, Sm, P0, PCNA, Histones, U1 snRNP, Ro/SS-A 60 kDa, Ro/SS-A 52 kDa, La/SS-B, Scl-70, CENP-B, Jo-1, Mi-2, PM/Scl, Ku and AMA/M2 in human serum or plasma samples.
General information:
Connective tissue diseases are systemic inflammatory rheumatic diseases usually characterized by a chronic course (systemic connective tissue diseases) with overlapping symptoms (Overlap- Syndromes). Connective tissue diseases include:
- Systemic lupus erythematosus (SLE) and subsets
- Sjögren`s syndrome
- Systemic sclerosis
- Idiopathic (autoimmune) myositis
- Mixed connective tissue disease (MCTD or Sharp syndrome)
- Overlap syndromes
Connective tissue diseases are characterized by typical autoantibody profiles, all detectable with SeraSpot® ANA-17 IgG.
Test principle:
SeraSpot® ANA-17 IgG is a solid phase immunoassay based on the use of recombinant or purified native proteins / protein complexes and dsDNA as capture antigens printed in array arrangement (spot array) on the bottom of the wells of 96-well microtiter plates. The antigens serve as capture molecules for autoantibodies to nuclear antigens (ANA). 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-002-17 G-S6 (1×48)
- SP-002-17 G-S12 (1×96)
| Art. No. | SP-002-17 G-S12 |
|---|---|
| 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.
