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

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  SDS [REF 5291][eng]   SDS [REF 5291][deu]   Flyer [ANA 18 Immunoblot][eng]

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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.