Rapid newborn test for congenital Chagas infection
Official title: Diagnostic assay for congenital Chagas disease
Funded at Kephera Diagnostics, LLC · NIH-11080292 · Data updated 2026-11-12
This project is creating a quick, easy-to-use test to detect Chagas infection in newborn babies born to mothers with Trypanosoma cruzi.
Quick facts
| Grant type | Sbir 1 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Kephera Diagnostics, LLC NIH-funded |
| Lab location | 1 site (Framingham, UNITED STATES) |
| Project start | May 1, 2024 |
| Project end | April 30, 2027 |
| Funding year | 2025 |
| Award (this year) | $303,250 |
| NIH project number | 5R43AI181234-02 |
| Project ID | NIH-11080292 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are newborns whose mothers are known or suspected to have T. cruzi infection, typically tested shortly after birth at participating hospitals or clinics.
✕Less likely to help
Adults with chronic Chagas or infants tested only many months after birth may not benefit from this newborn-focused diagnostic.
What this research studies
If my baby might have congenital Chagas, this project aims to make a point-of-care test that can find the infection within hours. The team is developing two IgM-based tests—a Western blot using native trypomastigote excreted/secreted antigen (TESA) and a peptide IgM ELISA using shed acute-phase antigen (SAPA)—and will advance the better-performing version. Both tests are designed to deliver results in about three hours and to improve consistency between batches and laboratories. They will be validated using panels of well-characterized newborn samples and appropriate controls.
Why it matters
Potential benefit: If successful, this could let infected infants be diagnosed and treated much earlier, when therapy is most effective and better tolerated.
How similar studies have gone: Current approaches (microscopy and delayed IgG testing) often miss cases or rely on late follow-up, and although antigens like TESA and SAPA have been researched, widely available point-of-care IgM tests for congenital Chagas are not yet established.
Where this research is happening
-
Kephera Diagnostics, LLC
Framingham, United States Active
Researchers
- Principal investigator: Levin, Andrew E. — Kephera Diagnostics, LLC
- Study coordinator: Levin, Andrew E.
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.