The Preg-OUT program shows how implementing Syphilis Health Check with an opt-out model can meaningfully boost syphilis screening rates in emergency departments, providing a critical tool in the fight against rising congenital syphilis cases. With cases climbing—posing serious risks to newborns—these findings underscore how point-of-care testing enables timely, life-saving interventions that may otherwise be out of reach, supporting healthier outcomes for both mothers and infants.
Conducted by McGovern Medical School at UTHealth Houston, the program illustrates how integrating Syphilis Health Check™—a highly accurate, FDA-cleared, CLIA-waived rapid test—can significantly improve testing rates for pregnant patients, increasing from 2% to 56.4%.1 This improvement highlights how rapid testing enables earlier identification and treatment, ultimately reducing transmission and adverse outcomes. These preliminary data were presented at the 2024 STI Prevention Conference in September.
The findings also suggest that Syphilis Health Check may support early diagnosis in newborns using heel-stick blood samples. Data from Preg-OUT confirm strong alignment with lab-based reference methods, establishing it as a reliable option for congenital syphilis testing in critical care settings.
“Many pregnant people visiting emergency departments are not routinely screened for syphilis, which can lead to missed opportunities for early diagnosis and treatment,” said Dr. Irene Stafford, a maternal-fetal medicine physician with McGovern Medical School at UTHealth Houston. “It is important to understand that these patients often can only come to the ED for care, and these visits represent a critical opportunity to reach them for syphilis screening early in pregnancy.”
Supporting Broader Adoption of Rapid Testing Strategies
With congenital syphilis cases increasing by over 250% in the past five years, expanding testing opportunities for populations without access to traditional care settings is critical.2 In Texas, congenital syphilis cases surged from 166 in 2017 to 922 in 2022—a staggering 455.4% increase that is closely tied to a broader rise in syphilis among women of childbearing age.3 The state now accounts for 25% of congenital syphilis cases nationwide, despite representing only about 10% of total births.3 This alarming trend is largely attributed to limited access to healthcare facilities, insurance, transportation, and other socio-economic barriers, as well as gaps in prenatal care and timely treatment. According to the Texas Department of State Health Services (DSHS), syphilis cases among women of childbearing age increased by 25% from 2021 to 2022, with 63% of the state’s congenital syphilis cases occurring in metropolitan areas.3 Inadequate testing and treatment during pregnancy remain critical challenges, as timely intervention could reduce the risk of congenital syphilis by 98%.3
“The rapid spread of syphilis poses a serious risk to both mothers and babies, and testing must be accessible at every point of care,” said Jeff Tobias, COO & Co-Founder of Diagnostics Direct. “Syphilis Health Check eliminates the wait time for results, enabling faster detection and the opportunity for immediate action. With highly accurate, dependable tests, we aim to empower providers to make informed decisions and diagnose infections earlier. The work Dr. Stafford and her team are doing to close the gap in care for pregnant individuals and their newborns is vital and sets a precedent for national implementation, potentially transforming care standards across the country.”
A Call for Action in Emergency Care Settings
Preg-OUT’s findings underscore the urgent need to address the barriers pregnant patients often face in accessing traditional care and testing. It is important to recognize that providing syphilis screening and treatment in emergency departments may be one of the only times a pregnant patient can get tested and treated. Treating patients in these settings is a significant step toward equitable care and is a crucial step in preventing the devastating outcomes of congenital syphilis.
Rapid point-of-care solutions, like Syphilis Health Check, empower healthcare providers to act swiftly, ensuring that syphilis cases are detected and treated wherever patients present, whether in the ED, rural clinics, or community care. This proactive approach is vital to protecting the health of both mothers and their babies.
To receive a digital copy of the posters, please click here. For more information on Syphilis Health Check™ or to subscribe for updates on similar programs, visit www.diagnosticsdirect2u.com.
About Diagnostics Direct
Diagnostics Direct, LLC is an experienced provider of CLIA-waived diagnostic tests for the detection of sexually transmitted infections (STIs). For more information about our company, visit diagnosticsdirect2u.com/about-us.
Disclaimers
The views expressed in this press release are those of the individual members of the Medical Advisory Board and not the institutions with which they are affiliated.
Syphilis Health Check™ is an FDA 510(k)-cleared, CLIA-waived rapid test for the detection of Treponema pallidum (syphilis) antibodies. It is being used under research use only (RUO) conditions for certain studies. Further studies evaluating the Syphilis IgM Health Check RUO with neonatal clinical outcomes are warranted.
Resources
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1 Haydamous, J., Davie, A., Noriega Valdez, J., Blackwell, A., Igbe, C., Bakunas, C., Klausner, J.D., Mena, L.A., & Stafford, I.A. (2024). Implementation of an Opt-out and Rapid POC Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department. Poster presented at STI Prevention Conference; Atlanta, Georgia. |
SOURCE Diagnostics Direct, LLC.
