A new test for Lyme disease that simplifies diagnosis
Official title: Hybrid ELISA: Simple and specific one-tier assay for Lyme disease
Funded at Kephera Diagnostics, LLC · NIH-10927442 · Data updated 2026-11-12
This study is working on a new test for Lyme disease that will make it faster and easier to get an accurate diagnosis, helping patients with symptoms get the right treatment sooner and avoid unnecessary antibiotics.
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 | 2024 |
| Award (this year) | $1,025,000 |
| NIH project number | 5R44AI142903-04 |
| Project ID | NIH-10927442 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are individuals exhibiting symptoms of Lyme disease or those who have been exposed to ticks in endemic areas.
✕Less likely to help
Patients who have already been diagnosed with Lyme disease and are receiving treatment may not benefit from this research.
What this research studies
This research focuses on developing a hybrid ELISA test for Lyme disease, which aims to streamline the current two-step testing protocol that often leads to delays in diagnosis and treatment. By improving the specificity of the assay, the goal is to reduce false positives and unnecessary antibiotic prescriptions. Patients who exhibit symptoms of Lyme disease will benefit from a quicker and more accurate diagnosis, potentially leading to timely treatment. The methodology involves advanced immunochemical techniques to enhance the detection of specific antigens related to Borrelia burgdorferi.
Why it matters
Potential benefit: If successful, this research could lead to faster and more accurate diagnoses of Lyme disease, reducing unnecessary antibiotic use.
How similar studies have gone: Previous research has shown promise in improving diagnostic assays for infectious diseases, indicating that this approach could yield significant advancements.
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.