Single-step, more accurate blood test for Lyme disease
Hybrid ELISA: Simple and specific one-tier assay for Lyme disease
This project is creating a single-step blood test that is easier to use and less likely to give false positives so people get faster, clearer Lyme diagnoses.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Kephera Diagnostics, LLC NIH-funded |
| Lab location | 1 site (Framingham, UNITED STATES) |
| Project ID | NIH-11158727 on NIH RePORTER |
What this research studies
You would be offered a new single-step blood test (a hybrid ELISA) that combines specific Borrelia antigens to better tell if your symptoms are caused by Lyme disease. The developers are designing the test to cut down on cross-reactions that cause false positives and to remove the need for a separate confirmatory immunoblot. They plan to validate the test using real human blood samples and compare results to the current two-step testing process. If the test proves more specific and reliable, it could speed up diagnosis and reduce unnecessary antibiotic prescriptions.
Who could benefit from this research
Good fit: Ideal candidates would be people being evaluated for suspected Lyme disease because of symptoms or a recent tick exposure, including those without the classic rash.
Not a fit: People with a clear early erythema migrans rash (who are usually diagnosed clinically) or those being tested for conditions unrelated to Lyme may not benefit from this test.
Why it matters
Potential benefit: If successful, the test could give faster, more accurate Lyme diagnoses and reduce unnecessary antibiotic use.
How similar studies have performed: Other single-step Lyme antibody tests have been tried but many suffered poor specificity and still required confirmation, so this hybrid approach is promising but needs clinical validation.
Where this research is happening
Framingham, UNITED STATES
- 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 below.