New Test Could Change Lyme Disease Testing

Lyme disease, caused by the bacterium Borrelia burgdorferi in the US and related species in Europe, is the most common vector-borne disease in the US, with nearly half a million cases annually. The earliest sign of infection is a skin rash called erythema migrans, but if left untreated, the disease can progress to neurological, joint, and cardiac complications. Current two-step laboratory tests, although standard since 1995, suffer from low sensitivity in early stages, delaying diagnosis and treatment. Now, a new single-tier antibody test has shown strong sensitivity in diagnosing early Lyme disease and could streamline detection.

The Hybrid Lyme ELISA test, developed jointly by Kephera Diagnostics (Framingham, MA, USA) and New York Medical College (Valhalla, NY, USA) along with collaborators, introduces a novel immunoassay principle. It capitalizes on the ability of antibodies from infected patients to simultaneously bind to two related but not identical antigens, a method never before used in diagnostics. This innovation enables both high sensitivity and specificity within a single test.

Image: The single-tier test showed >90% sensitivity in early Lyme disease patients (Photo courtesy of Shutterstock)

A study, published in the Journal of Clinical Microbiology, found that the Hybrid Lyme ELISA achieved more than 90% sensitivity in patients with erythema migrans. This is significantly higher than the sensitivity of existing two-step methods, which can miss up to 70% of such cases. Importantly, the new test also performed well in detecting later stages of the disease, matching the diagnostic accuracy of current FDA-approved protocols but with greater speed and efficiency.

Because the test is ELISA-based, it is compatible with both manual use and high-throughput automated laboratory platforms, making it adaptable across healthcare settings. If validated in larger clinical trials, this would be the first serologic test capable of reliably diagnosing Lyme disease at its earliest stage, while also confirming later manifestations. Kephera is currently pursuing regulatory approval and plans to make the test available through its CLIA-certified laboratory.

“Current two-tiered serology tests are insensitive in early Lyme disease, missing up to 70% of patients presenting with erythema migrans. More accurate tests are urgently needed, and the Hybrid ELISA results are very promising,” said Liz Horn, PhD, MBI, Principal Investigator at Lyme Disease Biobank and coauthor of the study.

Related Links:
Kephera Diagnostics
New York Medical College