Lyme disease: Gold Standard Diagnostics announces FDA clearance of new test
Gold Standard Diagnostics (GSD) recently announced FDA clearance of a new B. burgdorferi IgG/IgM VlsE-OspC EIA test. This test, when used in conjunction with the other FDA cleared GSD Lyme EIA tests can be used in the CDC recommended modified two-tiered testing (MTTT) algorithm. Borrelia burgdorferi spirochetes/CDC In 2014, the CDC issued an updated recommendation for the serologic diagnosis of Lyme disease, endorsing the use of a two-tier testing algorithm that uses a second enzyme immunoassay, or EIA, in place of a western immunoblot assay. Gold Standard Diagnostics now offers a solution fo...
Source: outbreaknewstoday.com