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Tag Archives: Zeus Scientific

Early Lyme disease detection

June 2023—Zeus Scientific has introduced the Zeus Borrelia Modified Two-Tiered Testing (MTTT) algorithm, an FDA-cleared all-ELISA algorithm designed to improve the detection of early Lyme disease by up to 30 percent compared with the standard two-tiered testing algorithm. It replaces a second-tier immunoblot with a second Zeus ELISA methodology to provide additional supportive evidence of infection. The company offers two algorithms: Zeus Borrelia MTTT-1 uses the Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system as a first-tier test followed by the Zeus B. burgdorferi IgG/IgM test system; Zeus Borrelia MTTT-2 uses the Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system as a first-tier test followed by the Zeus B. burgdorferi IgG test system and Zeus B. burgdorferi IgM test system.  

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FDA clears new indications for Lyme disease tests

November 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.

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FDA clears new indications for existing Lyme disease tests

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.

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