With syphilis rates surging in the U.S., the need for comprehensive and accessible testing solutions is greater than ever.
Syphilis rates have surged recently, according to the Centers for Disease Control and Prevention (CDC), contributing to the sexually transmitted infection (STI) epidemic that has shown no signs of slowing in the U.S. Chlamydia, gonorrhea and syphilis reached over 2.5 million reported cases in 2021 with syphilis rates increasing nearly 32% for combined stages of the infection from 2020 to 2021. Cases of congenital syphilis rose by 32% during that time and resulted in 220 stillbirths and infant deaths.
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. Syphilis is an STI caused by the bacterium Treponema pallidum (TP), which has a four-phase life cycle. Early detection and treatment of syphilis infections are important to prevent damage to the nervous system and to prevent spreading the bacteria to others. However, disruptions in STI-related prevention and care activities related to the U.S. response to the COVID-19 pandemic had a pronounced impact on trends in STI surveillance data.
The CDC says the nation must deepen its commitment to turn the STI epidemic around and prioritize both the increased involvement of multisectoral programs and groups and the creation of innovative prevention approaches and promising new tools. This includes making STI testing and treatment more accessible, including through the development and approval of point-of-care rapid tests and self-tests, and by expanding ownership for STI testing and treatment to more organizations and settings.
QuidelOrtho’s Vitros syphilis assay strengthens its position in infectious disease testing
QuidelOrtho Corp.’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. It recently received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Vitros syphilis assay as part of its menu, strengthening its 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 TP-specific antigens in human serum and plasma using the automated Vitros 3600 Immunodiagnostic System, and the Vitros 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.
“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 Dr. Lily Li, senior director, medical scientific and clinical affairs, QuidelOrtho.
The 2024 CDC guidelines equally recommend two diagnostic testing algorithms, both of which include using a treponemal and non-treponemal assay. Benefits of a CDC reverse testing algorithm include:
- Yielding a higher sensitivity for primary syphilis.
- Offering better detection of latent and tertiary infections.
- Reducing risk of false negative results due to prozone reactions.
- TP assays typically having higher specificity than rapid plasma regain (RPR) tests, which reduces unnecessary confirmatory testing.
Recommended syphilis screening for high-risk groups
The U.S. Preventive Services Task Force (USPSTF) recommends syphilis screening for high-risk groups including men who have sex with men/persons engaging in high-risk sexual behavior, commercial sex workers/persons exchanging sex for drugs, adults in correctional facilities, persons diagnosed with other STIs and pregnant women.
Women giving birth in the U.S. are now three times more likely to have syphilis than they were in 2016, according to the CDC. The sharp rise coincides with a spike in congenital syphilis or when a baby becomes infected before birth. Syphilis in infants can be severe, disabling and sometimes threaten their lives. More than 10,000 women who gave birth in 2022 had syphilis or about one maternal syphilis case for every 357 births.
The vast majority of congenital syphilis cases in the U.S. might have been prevented with better testing and treatment because, for pregnant women who are in the early stages of a syphilis infection that is left untreated, there’s a high likelihood that the infectious agent will pass through the placenta to the fetus. But timely treatment at least 30 days before delivery cuts the risk of infection passing from the mother to the baby by close to 100%.
The CDC recommends rebuilding, sustaining and expanding local public health services, especially efforts to offer STI testing and treatment programs that respond to the needs of those most affected.
Timely, accurate results when they matter the most
QuidelOrtho’s Vitros syphilis assay provides the performance expected with Vitros assays. The time to first result is 34 minutes, providing timely, accurate outcomes when they matter the most to help clinicians deliver the trust their patients need in them. Vitros syphilis assay performance highlights include:
- Low sample volume needed.
- High sensitivity/specificity.
- Reducing valuable tech hands-on time.
- Performing comparably to leading competitive assays in seroconversion study.
QuidelOrtho is a world leader in invitro diagnostics, developing and manufacturing intelligent solutions that transform data into understanding and action. It offers expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine, bringing fast, accurate and reliable diagnostics from home to hospital and lab to clinic, allowing patients, clinicians and health officials to spot trends sooner, respond quicker and chart the course ahead with accuracy and confidence.
It continues to partner with customers across the healthcare continuum and around the globe to power a healthier future for all.