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 for this Lyme testing algorithm, which complements GSD’s existing market-leading Lyme test portfolio.  With the addition of the B. burgdorferi IgG/IgM VlsE-OspC EIA test, customers can choose which tests and algorithms best meet their laboratory and client’s needs.  All six      assays are designed for optimal performance and can be run on any open automation platform.

“With the addition of the B. burgdorferi IgG/IgM VlsE-OspC EIA test to the GSD Lyme product portfolio, GSD is the first and only single source company to offer Lyme testing solutions for both the Standard and Modified Two-Tiered Testing algorithms,” said Dr. Barry Menefee, infectious disease specialist at GSD. “It is important to understand the need to combine assays designed to work in concert. By offering the laboratory complete testing solutions, optimization is always met.”

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Lyme disease: ≈476,000 patients diagnosed annually from 2010–2018