New Molecular Test Improves Diagnostic Accuracy of Lyme Disease

Diagnosing Lyme disease early remains one of the biggest challenges in infectious disease care. The condition is increasing across the United States, especially in the Northeast, although many patients never develop the classic bull’s-eye rash, and early antibody tests frequently return false negatives. This delay can allow the infection caused by Borrelia burgdorferi to progress and lead to joint, heart, and neurological complications. Researchers have now developed a molecular test that can identify previously missed cases of Lyme disease and allows for faster diagnosis

The new molecular test developed by researchers at Dartmouth Hitchcock Medical Center (Lebanon, NH, USA) detects Lyme-causing bacteria directly, bypassing the limitations of antibody-based testing. In the research presented at the Association for Molecular Pathology (AMP) 2025 Annual Meeting & Expo, the team designed three droplet digital PCR (ddPCR) assays: one detecting all Borrelia species, one targeting Lyme-associated species, and one specific to B. burgdorferi.

Image: The test detects Lyme-causing bacteria with far greater sensitivity than standard tests (Photo courtesy of Shutterstock)

In early testing on patient skin samples, the assays identified as few as five to ten bacterial cells and demonstrated high accuracy. The B. burgdorferi-specific test reached an estimated sensitivity of 90.9% in formalin-fixed, paraffin-embedded tissues, with even higher performance expected in fresh or frozen samples. Because serological tests cannot differentiate active disease from past exposure, the new molecular approach offers a clearer, more direct route to diagnosis.

The team is now aiming for broader validation across larger patient cohorts to refine the assay’s sensitivity. Early detection is key to preventing long-term complications, and the team’s work could shorten diagnostic delays for many patients. Since early diagnosis is vital to reducing the risk of long-term complications, the test’s further development will make it possible for more patients to receive prompt treatment.

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Dartmouth Hitchcock Medical Center