4074 – ANAscl^plus Dot

Highlights

• Slides coated with HEp-2 cells
• Screening test to support for the diagnosis of systemic autoimmune diseases
• Ready-to-use reagents (exception: wash buffer)
• Quality assured handling in routine laboratories
• Short incubation times (30 min / 30 min) at room temperature
• Consistent processing for the parallel use of multiple AKLIDES® IF assays
• Excellent diagnostic sensitivity and specificity
• Imaging by use of AKLIDES® or akiron® systems
• CE marked

Intended Use

The ANAscl^plus Dot is a qualitative dot immunoassay for the determination of IgG antibodies against nuclear and cytoplasmic antigens, including 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), and PCNA (proliferating cell nuclear antigen), in human serum. The ANAsclplus Dot is intended to assist clinicians in the diagnosis of systemic autoimmune diseases, complementing other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Systemic autoimmune diseases are often characterized by the presence of autoantibodies directed against components of the cell nucleus or cytoplasm. These autoantibodies serve as important diagnostic markers and aid in the differentiation of specific autoimmune conditions. Clinicians commonly find anti-Sm and anti-RNP antibodies in patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease (MCTD), while anti-SS-A and anti-SS-B antibodies frequently appear in patients with Sjögren’s syndrome. Clinicians typically detect antibodies targeting topoisomerase I (Scl-70) in systemic sclerosis and antibodies against PmScl in polymyositis-scleroderma overlap syndromes. Autoantibodies to Ku, CENP-A/B, and PCNA also contribute to subclassification and prognosis of autoimmune diseases. The detection of these antibodies in patient samples, such as serum or plasma, is a well-established method and plays a critical role in confirming diagnoses, guiding clinical management, and monitoring disease progression.