New Test Could Revolutionize Lyme Disease Diagnosis
The Innovative Single-step Test Showed More Than 90 Percent Sensitivity in Early Lyme Disease Detection in Clinical Evaluations
A new 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 by co-author Gary Wormser, M.D., professor of medicine, pathology, microbiology, and immunology, and of pharmacology, along with a group of researchers from across the country.
“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,” said Dr. Wormser.
Lyme disease, a tick-transmitted infection, is the most common vector-borne disease in the U.S., with almost half a million cases diagnosed annually, according to the U.S. Centers for Disease Control and Prevention (CDC). To date, laboratory testing for Lyme disease has relied on a standard two-step approach recommended by the CDC, in which blood samples are initially screened for antibodies to the spirochete Borrelia burgdorferi, typically through an enzyme-linked immunosorbent assay (ELISA). Those found to be positive are confirmed by a second antibody test.
The new single-tier Hybrid Lyme ELISA described in the study achieves higher sensitivity in the earliest stages of Lyme disease by using a novel immunoassay design that capitalizes on the discovery that antibodies produced during infection can bind simultaneously to two related—but distinct—antigens. This unique approach, never before used in diagnostic testing for any other infectious disease, enables the test to combine the sensitivity and specificity of the traditional two-step protocol into a single assay.
The sensitivity of the test in patients with erythema migrans, a skin rash at the tick bite site and the earliest and most common clinical manifestation of infection, was found to be more than 90 percent, significantly higher than the sensitivity of either of the currently FDA-approved two-tier testing methods. If these results are confirmed by further clinical evaluations, the new single-tier test would become the first Lyme disease serologic test that is sensitive enough to diagnose patients with erythema migrans, as well as patients with later stages of Lyme disease. Larger-scale clinical trials are currently underway.
The Hybrid Lyme ELISA was developed by Kephera Diagnostics with collaborators at New York Medical College and the Lyme Disease Biobank. The work was supported by an SBIR grant from the National Institute of Allergy and Infectious Diseases, an agency of the National Institutes of Health, to Kephera Diagnostics.
