Summary: QuidelOrtho Corp. received FDA 510(k) clearance for its VITROS syphilis assay, expanding its infectious disease test portfolio in the U.S. to address the growing syphilis epidemic.

Takeaways:

  1. The VITROS syphilis assay is now FDA-cleared for use in the U.S., offering a reliable method for detecting total antibodies to Treponema pallidum in human serum and plasma using automated VITROS systems.
  2. This assay enhances laboratory efficiency by aligning with the CDC’s reverse testing algorithm, reducing costs and the need for external lab referrals.
  3. The VITROS syphilis assay is intended for use on the automated VITROS 3600, 5600, and XT 7600 systems.

QuidelOrtho Corp. received U.S. Food and Drug Administration (FDA) 510(k) clearance for its VITROS syphilis assay as part of its menu, the company announced.

Syphilis Assay for Vitros Systems

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.

QuidelOrtho’s Testing Portfolio

QuidelOrtho’s infectious disease test portfolio spans the healthcare continuum from point-of-care settings to high-throughput laboratories and is critical in addressing the growing syphilis epidemic in the U.S. With over 176,000 new cases of syphilis reported annually, a 36% increase in the prevalence of primary and secondary syphilis since 2021, the need for comprehensive and accessible testing solutions has never been greater.

“As an in-demand assay for a common sexually transmitted infection (‘STI’), we are pleased to offer the VITROS syphilis assay, bolstering QuidelOrtho’s infectious disease test portfolio in the U.S.,” says Bryan Hanson, senior vice president, president North American Commercial Operations at QuidelOrtho. “Not only does this important assay improve laboratory efficiency by allowing labs to follow the CDC’s reverse testing algorithm for syphilis screening, it also reduces costs by providing earlier disease detection, thereby reducing the need to refer tests to outside labs.”

This expansion into the U.S. market aims to provide timely and accurate diagnosis, crucial for effective treatment and control of the disease.

Addressing STI Epidemic

“With an increased national incidence of syphilis and other STIs, having a quick and easy way to test in various healthcare settings is essential,” says Lily Li, senior director, Medical Scientific & Clinical Affairs, 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.

Featured image: VITROS XT 7600 Integrated System Photo: Business Wire