-

Improved Lyme Screening Assay Now FDA Cleared for Laboratory Use

B. burgdorferi VlsE-OspC IgG/IgM Assay helps with early Lyme Disease detection

DAVIS, Calif.--(BUSINESS WIRE)--Gold Standard Diagnostics (GSD) today announced it offers a new B. burgdorferi VlsE-OspC IgG/IgM recombinant ELISA Screen that can be used to improve workflow and conserve testing resources. This assay has demonstrated increased sensitivity for early Lyme Disease detection - up to 20% over existing available Lyme screening assays - while maintaining 98% specificity. True Lyme negative samples are eliminated prior to second-tier testing.

The OspC antigen used in this assay is highly specific for the detection of IgM antibodies, and when used in combination with the recombinant VlsE, produces a superior first-tier screen.

Optimized to be used with both second-tier Immunoblots and the new Modified Two-Tier Test (MTTT) algorithm, this increase in first-tier test specificity will reduce the number of second-tier tests required. This test can be automated on any open EIA processor, Time and costs are dramatically reduced in workflow.

For more information on these kits and GSD’s other products used in the effort to prevent the spread of COVID-19 please contact your local GSD representative, email USSales@gsdx.us, or www.gsdx.us.

ABOUT GOLD STANDARD DIAGNOSTICS, GROUP.

Gold Standard Diagnostics, Group is a clinical diagnostics group comprised of Gold Standard Diagnostics Inc., VIROTECH Diagnostics GmbH, and NovaTec Immundiagnostica GmbH. The companies develop, manufacture and distribute a portfolio of instrumentation and diagnostic test kits to clinical laboratories around worldwide. The US GSD Inc. is headquartered in Davis, CA. Gold Standard Diagnostics is a member of the Eurofins Technologies group of companies.

Contacts

Press Contact:
Barry Menefee, M.S., PhD
530-759-8000
USSales@gsdx.us

Gold Standard Diagnostics


Release Versions

Contacts

Press Contact:
Barry Menefee, M.S., PhD
530-759-8000
USSales@gsdx.us

More News From Gold Standard Diagnostics

Gold Standard Diagnostics Announces FDA Clearance of the B. burgdorferi IgG/IgM VlsE-OspC EIA Test

DAVIS, Calif.--(BUSINESS WIRE)--Gold Standard Diagnostics (GSD), a Eurofins Technologies company, today 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. 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...

Gold Standard Diagnostics Receives FDA 510K for Lyme IgG and IgM EIA Kits

DAVIS, Calif.--(BUSINESS WIRE)--The Gold Standard Diagnostics Group (GSD) today announced the immediate availability of their two new Lyme IgG and Lyme IgM EIA kits for detection of antibodies against Lyme disease causing bacteria. The two assays give laboratories a more diverse arsenal of testing methodologies that allows them to achieve more reliable results. The assays are available immediately in the US. The separate IgG and IgM assays provide laboratories the ability to offer more specific...

Gold Standard Diagnostics Multiplex Real-Time PCR Assay for SARS-CoV-2 Pathogen Detection Now Available in the US

DAVIS, Calif.--(BUSINESS WIRE)--Gold Standard Diagnostics Inc. today announced the EUA submission of a Multiplex Real-Time, reverse-transcriptase polymerase chain reaction (RT-PCR) assay for the direct qualitative pathogen detection of the novel coronavirus (SARS-CoV-2). The assay is available now for purchase in the U.S. Particularly in the early phase of COVID-19 infection, the direct and precise diagnostic of the pathogen is critical. PCR is the method of choice to detect acute coronavirus i...
Back to Newsroom