Syphilis Assay Improves Lab Efficiency and Reduces Costs Through Earlier Disease Detection

The prevalence of syphilis and other sexually transmitted infections (STIs) in the U.S. has seen a notable increase, with more than 176,000 new syphilis cases reported annually—a 36% rise in cases of primary and secondary syphilis since 2021. This surge underscores the urgent need for comprehensive and accessible diagnostic tools. In response, the Centers for Disease Control and Prevention recommends using both nontreponemal and treponemal serologic tests together to diagnose syphilis effectively. Now, a newly approved syphilis assay can provide timely and accurate diagnoses, which are vital for the effective treatment and management of the disease.

QuidelOrtho Corporation (San Diego, CA, USA) has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its VITROS syphilis assay as part of its menu. This assay, designed for use with the automated VITROS 3600, 5600, and XT 7600 systems, qualitatively determines the presence of total antibodies (IgG and IgM) to Treponema pallidum (TP)-specific antigens in human serum and plasma. The detection of TP-specific antibodies, when evaluated alongside non-treponemal test results and clinical assessments, assists in diagnosing syphilis. The VITROS syphilis assay is not intended for blood and tissue donor screening. With this FDA clearance, the VITROS syphilis assay is now available worldwide wherever QuidelOrtho products are sold.

Image: The VITROS Syphilis Assay has received FDA 510(k) clearance (Photo courtesy of QuidelOrtho)

“As an in-demand assay for a common STI, we are pleased to offer the VITROS syphilis assay, bolstering QuidelOrtho’s infectious disease test portfolio in the U.S.,” said 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.”

“With an increased national incidence of syphilis and other STIs, having a quick and easy way to test in various healthcare settings is essential,” said 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.”