Gold Standard Diagnostics (GSD) has launched a new Lyme Disease serologic assay, the B. burgdorferi IgG/IgM VlsE-OspC ELISA.

This assay has been FDA cleared for use as an integral part of the Modified Two-Tiered Testing algorithm (MTTT) available from GSD.

"Using the B. burgdorferi IgG/IgM VlsE-OspC test in combination with a second GSD Lyme EIA, we maintain >98% specificity while demonstrating a nearly 20% increase in early Lyme disease detection compared with the Standard Two-Tiered Testing algorithm (STTT)", said GSD in a press release.

Gold Standard Diagnostics is the only company offering kits in the U.S. to fulfill Lyme testing requirements for both the Standard and Modified two-tiered testing algorithms. Their four EIA kits and two Immunoblot kits allow flexibility for a lab to meet their clients’ needs. 

Image: Modified Two-Tiered Testing Algorithm (Credit: GSD)

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