FDA Clears Diagnostic Test for Systemic Lupus Erythematosus

The new SLE test enhances specificity without sacrificing sensitivity.

The US Food and Drug Administration has cleared a new diagnostic test for Systemic Lupus Erythematosus (SLE) that enhances specificity without sacrificing sensitivity.

The approval allows Thermo Fisher Scientific to move forward with the EliA SmDP-S test to provide a more precise diagnosis, while reducing the number of false positives.

"Diagnosing autoimmune diseases is often challenging," said Henry Homburger, MD, Professor Emeritus of Laboratory Medicine at Mayo Clinic College of Medicine, in a statement. "Existing serologic tests have less than ideal diagnostic specificity for SLE. With the new EliA SmDP-S assay, clinicians can have greater confidence for differentiating SLE from mixed connective tissue disease, because of the improved immuno-chemical specificity. This innovative test in turn, has the potential to improve treatment and outcomes for patients with SLE."

How It Works

The new test utilizes an advanced coating technique that is optimized for binding the synthetic SmD3 peptide antigen, which contains the most specific epitope for SmD3 peptide antibodies.

The antibodies that react with the SmD3 peptide do not cross react with other SmD3 peptides. This can improve the specificity of the test for distinguishing SLE from MCTD2.

"The new EliA SmDP-S replaces the former SmDP test to become a best-in-class test for the detection of Sm antibodies, providing clinicians with a higher degree of diagnostic confidence," said Homburger. "With its improved specificity, EliA SmDP-S could be used to further evaluate potential associations with systemic complications, including nephritis."