Improving molecular tests for congenital syphilis
Pre-Analytic Factors affecting Molecular tests for Congenital Syphilis
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 ID | NIH-11173804 on NIH RePORTER |
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.
Who could benefit from this research
Good fit: Ideal candidates are pregnant people with suspected or confirmed syphilis and newborns or infants born to mothers with syphilis or uncertain treatment history.
Not a fit: People without exposure to syphilis or adults with long-established syphilis diagnoses are unlikely to gain direct benefit from this diagnostic-methods work.
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 performed: 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
Dallas, United States
- Ut Southwestern Medical Center — Dallas, United States (Active)
Researchers
- Principal investigator: Sorelle, Jeffrey — Ut Southwestern Medical Center
- Study coordinator: Sorelle, Jeffrey
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 below.