IMTEC-SmD1-Antibodies is an indirect solid-phase enzyme immunoassay (ELISA) for the quantitative and qualitative measurement of IgG class autoantibodies against SmD1 peptide in human serum. The assay is intended for in vitro diagnostic use only as an aid in the diagnosis of systemic lupus erythematosus (SLE). Because they are highly specific, anti-Sm antibodies are an ACR criterion for systemic lupus erythematosus (SLE) and considered to be a pathognomic feature of the disease. Nonetheless, their diagnostic sensitivity is relatively low.

The use of a synthetic peptide representing the immunodominant epitope of SmD1 increases the sensitivity for anti-Sm antibodies in SLE patients to 70% associated with a specificity of nearly 94%. Relatively well confirmed is a positive association between the occurrence of anti-SmD1 antibodies and severe organ manifestations (e.g. kidney).

Code ITC60029  96Tests