A new serologic test for Lyme disease shows promise to streamline the testing protocol and to enable the diagnosis of patients in very early stages of the disease, as described in a study published online in the Journal of Clinical Microbiology, a publication of the American Society for Microbiology.
Dr. Gary P. Wormser, a co-author of the study at 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.”
The single-tier test described in the newly published study, which was developed by Kephera Diagnostics (Framingham, MA) and is called “Hybrid Lyme ELISA”, uses a novel immunoassay principle based on the finding that antibody molecules in human serum that are elicited by infection with the bacteria that cause Lyme disease can simultaneously bind to two related but not identical antigens. This approach, which has not been used in any previous diagnostic assay for any other infectious disease, makes possible for the first time a combination of sensitivity and specificity in a single test that rivals that of currently approved protocols that require two sequential tests. Furthermore, the sensitivity of this new single-tier test in patients with erythema migrans was found to be over 90%, 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, this new single-tier test would become the first Lyme disease serologic test that is sensitive enough to diagnose patients with erythema migrans, the earliest clinical manifestation of Lyme disease, as well as patients with later stages of Lyme disease. As an ELISA, this new test will be compatible with manual as well as high throughput automated testing procedures, enabling efficient performance in testing laboratories.
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.
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