CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
October 2018—Gold Standard Diagnostics announced FDA clearance of its Borrelia burgdorferi IgG/IgM ELISA assay. The test is intended as an initial screening assay in the CDC-recommended two-step testing for evidence of antibodies against the Lyme disease bacteria. Both steps can be performed using the same blood sample. The highly sensitive EIA Lyme screen contains B. burgdorferi strains B31 and 2591, as well as VIsE, an immunogenic lipoprotein included for optimal performance. The kit includes ready-to-use controls and features a 15-15-15-minute incubation protocol.
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