5291 – DotDiver ANA 18
Intended Purpose
The DotDiver ANA 18 is a qualitative line immunoassay for the determination of IgG antibodies against nuclear and cytoplasmic antigens (dsDNA, nucleosomes, Sm, Sm/RNP, ribosomal P0, histones, U1 snRNP, SS-A/Ro60, SS-A/Ro52, SS-B, Scl-70, PM/Scl-100, CENP-A/B, PCNA, Jo-1, M2, DFS-70 and f-actin) in human serum. The DotDiver ANA 18 is intended as an aid in the diagnosis of systemic inflammatory rheumatic 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 detection of antibodies in patient samples is well established and plays an essential role in the diagnosis of systemic autoimmune diseases. The appearance of antibodies 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.
Product Specifications
| Title | DotDiver ANA 18 |
| Product code | 5291 |
| Indication | Systemic inflammatory rheumatic diseases |
| Description | Line immunoassay for the qualitative determination of IgG antibodies against nuclear and cytoplasmic antigens in human serum |
| Format | Test strips coated with dsDNA, nucleosomes, Sm, Sm/RNP, ribosomal P0, histones, U1 snRNP, SS-A/Ro60, SS-A/Ro52, SS-B, Scl-70, PM/Scl-100, CENP-A/B, PCNA, Jo-1, M2, DFS-70 and f-actin |
| Total incubation time | 64 min. |
| Sample volume | 10 µL serum |
| No. of determinations | 24 x 18 |