Thermo Fisher Scientific’s EliA SmDP-S test has been cleared by the U.S. Food & Drug Administration (FDA) for aiding the diagnosis of Systemic Lupus Erythematosus (SLE), the most common type of lupus.
The company said the new test enhances specificity without sacrificing sensitivity, leading to a more precise diagnosis while also reducing the number of false positives.
The EliA SmDP-S utilizes a coating technique optimized for binding the synthetic SmD3 peptide antigen, which contains the most specific epitope for Sm peptide antibodies. Antibodies that react with SmD3 peptide do not cross react with other Sm peptides, which improves the specificity of this test for distinguishing SLE from mixed connective tissue disease, Thermo Fisher Scientific said.
