New Test Could Transform Lyme Disease Diagnosis, Study Finds
A new Hybrid Lyme ELISA test shows promise for faster, more accurate early detection of Lyme disease, potentially streamlining lab workflows and improving patient care.
A newly developed serologic test for Lyme disease could significantly improve early detection and streamline the diagnostic process, according to a study published in the Journal of Clinical Microbiology. Researchers say the test, called the Hybrid Lyme ELISA, offers higher sensitivity in the earliest stages of the disease than currently approved methods, potentially reshaping clinical practice.
For laboratory leaders, the emergence of the Hybrid Lyme ELISA marks a potentially pivotal shift in diagnostic testing. With Lyme disease cases approaching half a million annually in the US, labs remain at the forefront of detection and reporting, yet current two-step testing protocols are labor-intensive, time-consuming, and lack sensitivity in early-stage patients. A single-tier, high-sensitivity serologic test could streamline workflows, reduce turnaround times, and enable labs to deliver more actionable results—especially for patients who present with erythema migrans, where current methods fall short.
In a press release on the study, study co-author Gary P. Wormser, MD, New York Medical College said, “This test could potentially change the standard of clinical practice, allowing clinicians to diagnose all manifestations of Lyme disease with a time-saving one-step antibody test.”
Lyme Disease and Current Testing Challenges
Lyme disease, caused by the bacterium Borrelia burgdorferi in the US and related species in Europe, is the most common vector-borne illness in the country, with nearly half a million cases diagnosed each year, according to the Centers for Disease Control and Prevention (CDC). The earliest and most common symptom is a skin rash called erythema migrans, which appears at the site of a tick bite.
If untreated, the infection can spread and cause neurological, cardiac, and joint problems. Early antibiotic treatment is highly effective, but timely diagnosis has remained a challenge.
Since 1995, the CDC has recommended a two-step serology process: an initial antibody screening test, usually an ELISA, followed by a confirmatory test. Originally, the Western Blot was required for confirmation, but in 2019, the CDC allowed a second ELISA instead. While reliable, this sequential approach can delay results.
Neither method is sensitive enough to recommend testing for patients in the erythema migrans stage, leaving early cases often undiagnosed.
A One-Step Approach
Developed by Kephera Diagnostics in collaboration with New York Medical College and the Lyme Disease Biobank, the Hybrid Lyme ELISA employs a novel immunoassay principle. It takes advantage of a unique biological response in which antibodies generated by Borrelia infection can simultaneously bind to two related, though not identical, antigens.
This dual-binding design allows the test to achieve both high sensitivity and specificity in a single step—performance that rivals or exceeds current two-tiered testing.
In the study, the Hybrid ELISA showed sensitivity of more than 90% in patients with erythema migrans, an improvement over the low sensitivity of existing FDA-approved methods. That could make it the first serologic test capable of reliably diagnosing patients in the earliest stage of Lyme disease.
“Current two-tiered serology tests are insensitive in early Lyme disease, missing up to 70% of patients presenting with erythema migrans,” said study co-author Liz Horn, PhD, MBI, principal investigator of the Lyme Disease Biobank, a Bay Area Lyme Foundation program.
Liz Horn, PhD, MBI, principal investigator of the Lyme Disease Biobank noted, “More accurate tests are urgently needed, and the Hybrid ELISA results are very promising.”
Potential to Change Clinical Practice
As an ELISA, the new test can be run manually or on automated high-throughput systems, making it suitable for widespread use in clinical laboratories. Researchers believe it could reduce time, cost, and complexity in diagnosing Lyme disease, while providing earlier answers for patients.
“The publication of this study is an important milestone in our efforts to bring about meaningful improvements in the diagnosis of Lyme disease that will benefit both patients and clinicians,” said Andrew Levin, PhD, chief executive and scientific officer at Kephera Diagnostics. “We are very excited by the results that were achieved by the Hybrid Lyme ELISA in this initial study. Naturally, these findings will have to be corroborated in larger-scale trials, which are currently underway.”
Kephera Diagnostics is now pursuing regulatory approval for the test and plans to make it available through its CLIA-certified laboratory while larger trials continue.
Funding and Collaboration
The Hybrid Lyme ELISA was developed with support from the National Institute of Allergy and Infectious Diseases through a Small Business Innovation Research (SBIR) grant. Collaborators included scientists at New York Medical College and the Lyme Disease Biobank, which provided critical patient samples.
If validated in larger trials and approved, experts say the test could become the first widely available one-step serologic test for Lyme disease, capable of diagnosing patients from the earliest rash stage through later, systemic disease.
—Janette Wider
