QuidelOrtho Corporation has received US FDA 510(k) clearance for its VITROS syphilis assay. Using the automated VITROS systems, this assay is intended for the qualitative determination of total (IgG and IgM) antibodies to Treponema pallidum (TP)-specific antigens in human serum and plasma using the automated VITROS 3600, 5600, and XT 7600 systems. The presence of antibodies to TP-specific antigens, in conjunction with non-treponemal laboratory tests and clinical findings, may aid in the diagnosis of syphilis infection. The syphilis assay is not intended for blood and tissue donor screening.