THURSDAY, Aug. 1, 2019 (HealthDay News) -- Four tests have been cleared for marketing with new indications to diagnose Lyme disease using a modified approach with only enzyme immunoassay (EIA) technology-based tests, the U.S. Food and Drug Administration announced this week.
The tests follow a new testing paradigm involving two EIAs run concurrently or sequentially as an alternative to the current two-step process in which the Western Blot has to run after the initial EIA.
The four tests include 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 ZEUS ELISA Borrelia burgdorferi IgG Test System. In clinical trials of these four tests, the alternative modified two-tier test approach was as accurate as current methods in assessing exposure to Borrelia burgdorferi.
According to data from the U.S. Centers for Disease Control and Prevention, in 2017, there were 42,743 confirmed and probable cases of Lyme disease -- an increase of 17 percent over 2016. The FDA notes that CDC recommendations should be followed for diagnosis of Lyme disease and for determining when laboratory tests are necessary.
Marketing clearance of the tests was granted to ZEUS Scientific.