8101 ANA HEp-2 plus

Highlights

• Slides coated with HEp-2 cells
• Screening test to support for the diagnosis of systemic autoimmune diseases
• Qualitative and semi-quantitative determination of the IgG antibody activity
• Ready-to-use reagents (exception: PBS 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 IF assays
• High diagnostic sensitivity and specificity
• CE marked

Intended Purpose

The ANA HEp-2 plus is an immunofluorescence assay (IFA) for the qualitative and semi-quantitative determination of IgG antibodies in human serum against nuclear and cytoplasmic antigens using HEp-2 cells. The ANA HEp-2 plus 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 diagnosis of autoimmune diseases is made on the basis of the clinical symptoms and laboratory medical examinations. The clinical suspicion is confirmed in particular by the detection of antibodies against nuclear or cytoplasmic antigens (ANA) as a characteristic feature in systemic autoimmune diseases such as systemic lupus erythematosus (SLE), Sjögren‘s syndrome, progressive systemic sclerosis (PSS), mixed collagenosis (MCTD), rheumatoid arthritis (RA) or dermatomyositis. The use of HEp-2 cells fixed on slides for use in immunofluorescence assays (IFA) has proven to be particularly effective for the determination of antibodies. These immunoassays offer the possibility for a very sensitive detection of antibodies against nuclear or cytoplasmic antigens (ANA). The observed fluorescence pattern also gives an indication of the antigen specificity of the detected antibodies and thus of the autoimmune disease to be diagnosed.