4291 – ANA 18 LINE

Intended Purpose

The ANA 18 LINE is a qualitative line immunoassay for the determination of IgG antibodies against nuclear and cytoplasmic antigens (dsDNA, nucleosome, Sm, Sm/RNP, ribosomes, histone, U1-snRNP, SS-A 60, SS-A 52, SS-B, Scl-70, PM/Scl, CENP-A/B, PCNA, Jo-1, M2, DFS-70 and f-Actin) in human serum. The ANA 18 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 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 ANA 18 LINE
Product code 4291
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, nucleosome, Sm, Sm/RNP, ribosomes, histone, U1-snRNP, SS-A 60, SS-A 52, SS-B, Scl-70, PM/Scl, CENP-A/B, PCNA, Jo-1, M2, DFS-70 and f-Actin
Total incubation time 80 min.
Sample volume 10 µL serum
No. of determinations 20 x 18

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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.