Improving molecular tests for congenital syphilis
Official title: Pre-Analytic Factors affecting Molecular tests for Congenital Syphilis
Funded at Ut Southwestern Medical Center · NIH-11173804 · Data updated 2026-11-12
Checking how the way samples are collected and handled affects a new molecular test that aims to directly detect syphilis in pregnant people and newborns.
Quick facts
| Grant type | R21 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Ut Southwestern Medical Center NIH-funded |
| Lab location | 1 site (Dallas, United States) |
| Project start | August 20, 2024 |
| Project end | July 31, 2026 |
| Funding year | 2025 |
| Award (this year) | $205,000 |
| NIH project number | 5R21AI185968-02 |
| Project ID | NIH-11173804 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are pregnant people with suspected or confirmed syphilis and newborns or infants born to mothers with syphilis or uncertain treatment history.
✕Less likely to help
People without exposure to syphilis or adults with long-established syphilis diagnoses are unlikely to gain direct benefit from this diagnostic-methods work.
What this research studies
This work looks at how pre-test factors—like the type of sample (blood, amniotic fluid, or newborn swabs), how long samples sit before testing, and how they are stored—change the accuracy of a PCR-based test for Treponema pallidum. Researchers will run molecular tests on different kinds of specimens and compare results after varying collection and handling conditions to find what gives the most reliable detection. The project focuses on samples from pregnant people, newborns, and early infants to target congenital syphilis. Findings will inform how hospitals and labs should collect and transport samples so a direct test could work better in real-world care.
Why it matters
Potential benefit: If successful, this could lead to a reliable direct test that helps doctors detect syphilis in babies earlier and make clearer treatment decisions.
How similar studies have gone: PCR-based detection of T. pallidum has worked in some sample types, but prior results have been inconsistent and no routine molecular newborn test has been established.
Where this research is happening
-
Ut Southwestern Medical Center
Dallas, United States Active
Researchers
- Principal investigator: Sorelle, Jeffrey — Ut Southwestern Medical Center
- Study coordinator: Sorelle, Jeffrey
Related research
Other NIH-funded projects on the same topics.
-
Syphilis in Pregnancy: Understanding Infection in Moms and Babies
A study following pregnant women with syphilis and their babies to learn how the infection affects pregnancy and newborn health.
-
Syphilis in Pregnancy: Molecular Tests and Immune Responses in Mom and Baby
A study to understand how syphilis affects pregnancy and newborns by using molecular tests and tracking immune responses in 750 pregnant women with syphilis and their babies.
-
Crowdsourced digital messaging to boost syphilis and HIV testing for women in NYC and rural Alabama
A community-driven project tests whether crowdsourced digital messages can encourage women, especially women of color and Native American women, to get syphilis, HIV, and STI tests.
-
Preventing syphilis in pregnant people in Rio de Janeiro
A clinical trial in Brazil tests a pregnancy-safe antibiotic plan to stop syphilis from affecting babies.
-
Cefixime vs Penicillin G for Early Syphilis in HIV and non-HIV patients
This project compares a cefixime-based treatment to standard penicillin for early syphilis in people with and without HIV.
-
Preventing congenital syphilis in pregnant people at risk in Rio de Janeiro
A clinical trial will test a treatment approach during pregnancy to reduce syphilis transmission from mother to baby for pregnant people at risk in Rio de Janeiro.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.