4074 – ANAsclplus Dot

Intended Purpose

The ANAsclplus Dot is a qualitative dot immunoassay for the determination of IgG antibodies against nuclear and cytoplasmic antigens (Sm, Sm/RNP, SS-A, SS-B, Jo-1 (histidyl-t-RNA synthetase), Scl-70 (topoisomerase I), PmScl, Ku, CENP-A/B (Centromer proteins A and B), PCNA (proliferating cell nuclear antigen)) in human serum. The ANAsclplus Dot 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 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 ANAsclplus Dot
Product code 4074
Indication Systemic autoimmune diseases
Description Dot Immunoassay for the determination of IgG antibodies against nuclear and cytoplasmic antigens in human serum
Format Test strips coated with Sm, Sm/RNP, SS-A, SS-B, Jo-1, Scl-70, PmScl, Ku, CENP-A/B and PCNA
Total incubation time 80 min.
Sample volume 10 µL serum
No. of determinations 24 x 10

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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.