August 2021—Gold Standard Diagnostics announced the availability of its FDA-cleared B. burgdorferi VlsE-OspC IgG/IgM recombinant ELISA screen. The OspC antigen is highly specific for the detection of IgM antibodies and produces a superior first-tier screen, the company says, when used in combination with the recombinant VlsE. True Lyme-negative samples are eliminated prior to second-tier testing.
The assay has a specificity of 98 percent and has demonstrated a nearly 20 percent increase in early Lyme disease detection compared with the standard two-tier testing algorithm.
The test is optimized for use with second-tier immunoblots and the modified two-tier test algorithm and can be automated on any open EIA processor.
Gold Standard Diagnostics, 855-268-6940