Single-step, more accurate blood test for Lyme disease
Official title: Hybrid ELISA: Simple and specific one-tier assay for Lyme disease
Funded at Kephera Diagnostics, LLC · NIH-11158727 · Data updated 2026-11-12
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 start | March 6, 2019 |
| Project end | August 31, 2026 |
| Funding year | 2025 |
| Award (this year) | $714,666 |
| NIH project number | 5R44AI142903-05 |
| Project ID | NIH-11158727 on NIH RePORTER |
Who could benefit from this research
✓Could help
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.
✕Less likely to help
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.
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.
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 gone: 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
-
Kephera Diagnostics, LLC
Framingham, United States Active
Researchers
- Principal investigator: Levin, Andrew E. — Kephera Diagnostics, LLC
- Study coordinator: Levin, Andrew E.
Related research
Other NIH-funded projects on the same topics.
-
Understanding why some people have ongoing symptoms after Lyme disease
A long-term study follows people diagnosed with acute Lyme disease to see who develops persistent symptoms and why, with care from a team of Lyme experts.
-
CSF Protein Map in Post-Treatment Lyme Disease
A short study to map proteins in spinal fluid of people who had Lyme disease and still feel sick after standard treatment, to understand what’s going on.
-
Lyme disease vaccine research aimed at preventing infection
Researchers are developing a Lyme disease vaccine by studying how the immune system responds to Borrelia burgdorferi and testing vaccine approaches to prevent illness.
-
Lyme disease brain health: tracking brain signals and blood clues after treatment
This study follows people with early Lyme disease and compares them to healthy volunteers to see how the brain and blood markers change over a year after starting antibiotics.
-
Lyme disease symptoms lingering after treatment may be driven by special bacterial fragments
A human-friendly look at a study exploring why some Lyme patients keep symptoms after antibiotics and whether tiny fragments from the bacteria are to blame.
-
Understanding Lyme disease immune signals to predict recovery after antibiotics
A research project at MIT aims to find immune biomarkers that tell which Lyme patients will recover after standard antibiotics and who might have lasting symptoms.
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.