CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Aug. 1, 2019—The U.S. Food and Drug Administration cleared for marketing four previously cleared tests with new indications to aid in the diagnosis of Lyme disease. The tests cleared involve a new testing paradigm in which two enzyme immunoassays are run concurrently or sequentially, rather than the current two-step process in which a Western blot must be run after the initial EIA test.
The FDA reviewed data from clinical studies of the Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System, Zeus ELISA Borrelia burgdorferi IgG/IgM Test System, Zeus ELISA Borrelia burgdorferi IgM Test System, and the Zeus ELISA Borrelia burgdorferi IgG Test System that showed the modified two-tier test is as accurate as current methods for detecting antibodies for assessing exposure to Borrelia burgdorferi.