Special remarks:

The ANA Profile assay is an indirect solid phase enzyme immunometric assay (ELISA) for the qualitative determination ANA autoantibodies directed against RNP-70, RNP/Sm, Sm, SS-A, SS-B, Scl-70, Centromer B and Jo-1 in human serum or plasma. The assay is intended for in vitro diagnostic use only as an aid in the diagnosis of certain systemic rheumatic diseases.

Inflammatory connective tissue diseases are characterized by idiopathic genesis along with disturbances in terms of cellular and humoral immunity, systemic organ failure and a chronic course of disease.  Additionally, connective tissue diseases exhibit overlapping symptomatic features that render an accurate diagnosis difficult.

Considering the diversity of mixed connective tissue diseases, such disorders exhibit a common serological characteristic; the presence of anti-nuclear antibodies. These antibodies are directed against parts of the cell nucleus and the cytoplasm, and many rheumatic diseases are characterized by the presence of one or more of these ANAs.

Antibodies to double-stranded DNA (dsDNA), single-stranded DNA (ssDNA), histone, nuclear ribonucleoprotein (RNP) and Smith antigen (Sm) are associated with SLE, while antibodies to Sjogren´s Syndrome A (SSA/Ro) and Sjogren´s Syndrome B (SSB/La) can occur in both SLE and Sjogren´s Syndrome (SS). Antibodies to Jo-1 may be observed in polymyositis and dermatomyositis, while antibodies to scleroderma-associated antigen (Scl-70) and centromere can occur in patients with progressive systemic sclerosis (PSS). Anti-histone antibodies are associated with SLE and drug-induced lupus, while anti-RNP antibodies are linked with mixed connective tissue disease (MCTD) and with SLE. Antibodies directed against centromere are associated with CREST syndrome.