August 30, 2024- QuidelOrtho Corporation has received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for its VITROS syphilis assay as part of its menu, strengthening QuidelOrtho’s position as a leader in infectious disease testing. 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 VITROS syphilis assay is not intended for blood and tissue donor screening. With the addition of the U.S., the VITROS syphilis assay is now available globally where QuidelOrtho products are available. This expansion into the U.S. market aims to provide timely and accurate diagnosis, crucial for effective treatment and control of the disease.