FDA clears Thermo Fisher's new blood test for lupus

2020 05 07 22 15 9104 Thermo Fisher Scientific 400

The U.S. Food and Drug Administration (FDA) cleared Thermo Fisher Scientific's blood test for diagnosing systemic lupus erythematosus (SLE), the most common type of lupus.

The EliA SmDP-S Test is designed to reduce the number of false-positive results and provide improved diagnostic guidance for SLE. The new test enhances specificity without sacrificing sensitivity, Thermo Fisher said.

Specifically, the EliA SmDP-S test employs 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 the SmD3 peptide do not cross-react with other Sm peptides, which improves the specificity of the test, the company reported.

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