Improved Lyme Screening Assay Now FDA Cleared for Laboratory Use

Davis, CA – April 16, 2021 – Gold Standard Diagnostics (GSD) today announced it offers a new B. burgdorferi VlsE-OspC IgG/IgM recombinant ELISA Screen that can be used to improve workflow and conserve testing resources. This assay has demonstrated increased sensitivity for early Lyme Disease detection - up to 20% over existing available Lyme screening assays - while maintaining 98% specificity. True Lyme negative samples are eliminated prior to second-tier testing.  

The OspC antigen used in this assay is highly specific for the detection of IgM antibodies, and when used in combination with the recombinant VlsE, produces a superior first-tier screen.

Optimized to be used with both second-tier Immunoblots and the new Modified Two-Tier Test (MTTT) algorithm), this increase in first-tier test specificity will reduce the number of second-tier tests required.  This test can be automated on any open EIA processor, Time and costs are dramatically reduced in workflow.

For more information on these kits and GSD’s other products used in the effort to prevent the spread of COVID-19 please contact your local GSD representative, email, or


Gold Standard Diagnostics, Group is a clinical diagnostics group comprised of Gold Standard Diagnostics Inc., VIROTECH Diagnostics GmbH, and NovaTec Immundiagnostica GmbH. The companies develop, manufacture and distribute a portfolio of instrumentation and diagnostic test kits to clinical laboratories around worldwide.  The US GSD Inc. is headquartered in Davis, CA.  Gold Standard Diagnostics is a member of the Eurofins Technologies group of companies.

Barry Menefee, M.S., PhD