CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
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.
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