VITROS Syphilis Assay Now Available on VITROS 3600 Immunodiagnostic System, VITROS 5600 and VITROS XT 7600 Integrated Systems in the US

QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”) has received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for its VITROS syphilis assay as part of its menu, further 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 combination with nontreponemal laboratory testing and clinical findings, may aid in the diagnosis of syphilis infection. The VITROS syphilis test is not intended for screening blood and tissue donors. With the addition of the U.S., the VITROS syphilis test is now available worldwide wherever QuidelOrtho products are available.

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