4010 – ANAscreen

Highlights

• Use of recombinant deamidated gliadin
• Semi-quantitative determination in human serum
• Use as an aid in the diagnosis of systemic autoimmune disorders
• Detection of total ANA as a summary parameter in a single sample
•  Quantitative determination of IgA antibodies against deamidated gliadin
• combined HeLa nuclei, recombinant proteins, and native antigens for high sensitivity and specificity
• Manual test for professional in vitro diagnostic use
• CE marked

Intended Purpose

The ANAscreen is a semi-quantitative enzyme immunoassay for the determination of IgG antibodies directed against nuclear and cytoplasmic antigens in human serum. The assay allows the detection of total antinuclear antibodies (ANA) as a screening parameter using a combination of complete HeLa nuclei, recombinant proteins, and purified native antigens.

ANAscreen is intended for use as an aid in the diagnosis of systemic autoimmune disorders in conjunction with other clinical findings and laboratory test results. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

The presence of autoantibodies against nuclear and cytoplasmic components characterizes systemic autoimmune diseases. These diseases include systemic lupus erythematosus (SLE), Sjögren’s syndrome, progressive systemic sclerosis (PSS), mixed connective tissue disease (MCTD), rheumatoid arthritis (RA), and dermatomyositis. Laboratories have well established the detection of these autoantibodies. It plays a central role in the diagnosis and differential diagnosis of systemic autoimmune disorders.

ANAscreen enables the detection of total IgG autoantibodies against nuclear and cytoplasmic antigens in a single serum sample, providing a reliable screening parameter for systemic autoimmune diseases. The assay is based on an optimized antigenic composition combining complete HeLa cell nuclei with recombinant proteins and purified native antigens. This antigen combination ensures broad antigen coverage and supports high diagnostic sensitivity and specificity. Therefore, ANAscreen is suitable as an initial screening assay and as a complement to disease-specific autoantibody testing in routine laboratory diagnostics.