5035 – DotDiver ANA PCNA
Intended Purpose
The DotDiver ANA PCNA is a qualitative dot immunoassay for the determination of IgG antibodies against nuclear and cytoplasmic antigens (Sm, RNP, Sm/RNP, SSA(Ro), SSB(La), Jo-1, Scl-70, PM-Scl, Ku, CENPA/B, PCNA and Ribosome P0) in human serum. The DotDiver ANA PCNA is intended as an aid in the diagnosis of systemic autoimmune diseases in conjunction with other clinical and laboratory findings. The immunoassay is designed for semi-automated use with the DotDiver instrument. The immunoassay is designed for professional in vitro diagnostic use.
Diagnostic Relevance
The appearance of autoantibodies directed against components of the cell nucleus are characteristic features of systemic autoimmune diseases, especially; systemic lupus erythematosus (SLE), Sjögren’s syndrome, progressive systemic sclerosis (PSS), mixed connective tissue disease (MCTD), rheumatoid arthritis (RA) and dermatomyositis. The detection of auto-antibodies in patient sample, e.g. plasma and serum, is well established and plays an essential role in the diagnosis of systemic autoimmune diseases.
Product Specifications
| Title | DotDiver ANA PCNA |
| Product code | 5035 |
| Indication | Systemic autoimmune diseases |
| Description | Dot immunoassay for the qualitative determination of IgG antibodies against nuclear and cytoplasmic antigens in human serum |
| Format | Test strips coated with Sm, RNP, Sm/RNP, SSA(Ro), SSB(La), Jo-1, Scl-70, PM-Scl, Ku, CENPA/B, PCNA and Ribosome P0 |
| Total incubation time | 64 min. |
| Sample volume | 10 µL serum |
| No. of determinations | 24 x 12 |