8101 ANA HEp-2 plus

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 appearance of autoantibodies directed against components of the cell nucleus are characteristic features 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 auto-antibodies in patient sample, e.g. plasma and serum, is well established and plays an essential role in the diagnosis of systemic autoimmune diseases.  The use of Hep-2 cells in immunofluorescence assay offers a very sensitive screening approach to detect antinuclear antibodies (ANA) directed against components of the cell nucleus. By identifying the staining patterns on HEp-2 cells, the identification of the antigen targeted by ANA and the associated autoimmune disorders is achieved.

 The IFA (indirect immunofluorescence assay) is an immunoassay for the determination of specific antibodies. Tissue sections or cells containing the antigen of interest are immobilized on slides. If specific antibodies are present in the patient´s sample, they bind to the antigen in the tissue. A secondary antibody conjugated with fluorescein-isothiocyanat (FITC) detects the generated immune complex. The slides are examined using a fluorescence microscope. A specific fluorescent staining pattern demonstrates the presence of specific antibodies in the patient´s sample.

The immunoassay is designed for manual professional in vitro diagnostic use.