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.
Read More »FDA clears GSD’s B. burgdorferi VlsE-OspC IgG/IgM assay
May 14, 2021—Gold Standard Diagnostics announced the availability of its FDA-cleared B. burgdorferi VlsE-OspC IgG/IgM recombinant ELISA screen.
Read More »B. burgdorferi IgG/IgM ELISA assay cleared
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.
Read More »FDA-cleared RPR test system, 5/16
May 2016—Gold Standard Diagnostics announced FDA 510(k) clearance of its AIX1000 Rapid Plasma Reagin Automated Test System for syphilis testing.
Read More »Vitamin D assay, 9/13:103
Gold Standard Diagnostics announced FDA 510(k) clearance of its 25-OH vitamin D, total ELISA. This assay correlates with established liquid chromatography/mass spectrometry, enzyme immunoassay, and chemiluminescence methods, and offers high sensitivity and specificity over a wide dynamic range. The assay can be automated on a variety of instruments, providing a cost-effective vitamin D testing option even at lower volumes.
Read More »Next-gen Lyme testing, 8/13:87
Gold Standard Diagnostics’ new Line Immunoassay technology for Lyme confirmation testing gives clinical laboratories an FDA-cleared option for serological confirmation testing for Lyme disease according to the CDC-recommended two-step process.
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