4289 – ANA 12 LINE

Intended Use

The ANA 12 LINE is a qualitative line immunoassay for the determination of IgG antibodies against nuclear and cytoplasmic antigens (dsDNA, nucleosome, Sm, ribosomes, histone, RNP, SS-A 60, SS-A 52, SS-B, Scl-70, CENP-B and Jo-1) in human serum. The ANA 12 LINE 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 manual 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 autoantibodies 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 ANA 12 LINE
Product code 4289
Indication Systemic autoimmune 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, nucleosome, Sm, ribosomes, histone, RNP, SS-A 60, SS-A 52, SS-B, Scl-70, CENP-B and Jo-1
Total incubation time 80 min.
Sample volume 20 µL serum
No. of determinations 20 x 12

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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.