4012 – ANApro

Pipetting on enzyme-immunoassay (ELISA) microplate at Medipan and GA Generic Assays Lab.

Intended Purpose

The ANApro is a semi-quantitative immunoassay for the separate determination of IgG antibodies against nuclear and cytoplasmic antigens (dsDNA, RNP, Sm, SS-A, SS-B, Scl-70, CENP, Jo-1) in human serum. The ANApro is intended as an aid in the diagnosis of systemic autoimmune disorders 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 is a characteristic feature 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 antibodies in patient samples is well established and plays an essential role in the diagnosis of systemic autoimmune diseases.

By allowing the detection of autoantibodies to dsDNA as well as autoantibodies to extractable nuclear and cytoplasmic protein antigens, ANApro offers a rapid and practical opportunity for the determination of the whole autoantibody pattern in systemic autoimmune diseases on one test plate. By combining specified recombinant antigens with selected highly purified antigens, maximum specificity for these parameters is guaranteed.

Product Specifications

Title ANApro
Product code 4012
Indication Systemic autoimmune diseases
Description Enzyme immunoassay for the separate semi-quantitative determination of IgG antibodies against nuclear and cytoplasmic antigens in human serum
Format Microtiter plate coated with dsDNA, RNP (68kDa, A, C), Sm, SS-A, SS-B, Scl-70, CENP or Jo-1
Total incubation time 105 min.
Sample volume 10 µL serum
No. of determinations 96 (10 x 8) + 1 x 8 Calibrators + 1 x 8 Controls

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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.