Syphilis Assay Is Now Available on VITROS 3600, 5600, and 7600 Systems in the US
There’s been a 36 percent increase in cases of primary and secondary syphilis since 2021
SAN DIEGO, CA, AUGUST 29, 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.
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 US, the VITROS syphilis assay is now available globally where QuidelOrtho products are available.
QuidelOrtho’s infectious disease test portfolio spans the health care continuum from point-of-care settings to high-throughput laboratories and is critical in addressing the growing syphilis epidemic in the US. With over 176,000 new cases of syphilis reported annually, a 36 percent increase in the prevalence of primary and secondary syphilis since 2021, the need for comprehensive and accessible testing solutions has never been greater.
This expansion into the US market aims to provide timely and accurate diagnosis, crucial for effective treatment and control of the disease.
“With an increased national incidence of syphilis and other STIs, having a quick and easy way to test in various health care settings is essential,” said Lily Li, senior director of medical scientific and clinical affairs at QuidelOrtho. “The CDC Morbidity and Mortality Weekly Report, updated in February 2024, recommends that both nontreponemal and treponemal serologic tests be used in conjunction to aid in the diagnosis of syphilis.”
QuidelOrtho continues to expand its menu for infectious disease testing and beyond to help our customers provide the highest level of patient care.
- This press release was originally published on QuidelOrtho’s website.