Description

The Diagnostic Automation Smith(Sm)ELISA kit is intended for the detection and semi-quantitation of antibodies to Sm in human sera. The assay is to be used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of autoimmune disease. For in vitro diagnostic use. High complexity test.

Systemic autoimmune disease is characterized by the presence of circulating auto antibodies directed to a wide variety of cellular antigens. Systemic lupus erythematosis (SLE) commonly referred to as Lupus is the best known of these diseases. Other possible connective tissue diseases include mixed connective tissue disease (MCTD), Sjogren syndrome, sclerodema, and polymyositis/dermatomyositis. The majority can be diagnosed by clinical presentation and their antibody profiles to the various antigens involved, which include dsDNA, Sm, RNP, Ro, La, Scl-70, Jo-1 and Histones. Therefore, immunoassays for auto antibodies are useful for diagnostic and prognostic evaluations of autoimmune disease. The Sm or Smith antigen is composed of nuclear RNA and several polypeptides. Antibodies to Sm are present in approximately 30% of patients with SLE. Sm is a very specific marker for SLE. Sm antibodies are very rare in other autoimmune diseases and normals. Classically, antibodies to autoimmune antigens are detected by double immunodiffusion. However, the test is lengthy and suffers from weak sensitivity. Enzyme-Linked Immunosorbent Assays (ELISAs) combine greater sensitivity with ease of use. Many ELISAs have been developed and validated for detecting auto antibodies to various antigens.