4010 – ANAscreen

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

Intended Purpose

The ANAscreen is a semi-quantitative immunoassay for the determination of IgG antibodies against nuclear and cytoplasmic antigens in human serum. The ANAscreen 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 autoantibodies in patient sample is well established and plays an essential role in the diagnosis of systemic autoimmune diseases.

The use of antigenic combination of complete HeLa nuclei with recombinant proteins and purified native antigens offers a very sensitive screening approach to detect antinuclear antibodies (ANA) directed against nuclear and cytoplasmic antigens. ANAscreen allows the detection of total autoantibodies in one sample as a summary or profile parameter in the diagnosis of systemic autoimmune disorders.

Product Specifications

Title ANAscreen
Product code 4010
Indication Systemic autoimmune diseases
Description Enzyme immunoassay for the semi-quantitative determination of IgG antibodies against nuclear and cytoplasmic antigens in human serum
Format Microtiter plate coated with HeLa nuclei and enriched with recombinant and native antigens
Total incubation time 105 min.
Sample volume 10 µL serum
No. of determinations 96 (93 x 1) + 1 x Calibrators + 2 x 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.