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Gold Standard Diagnostics gets FDA nod for Borrelia burgdorferi IgG/IgM ELISA assay

MDBR Staff Writer Published 14 June 2018

Gold Standard Diagnostics (GSD) has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Borrelia burgdorferi IgG/IgM ELISA assay.

The test has been developed to serve as an initial screening assay in the CDC recommended two steps testing for evidence of antibodies against the Lyme disease bacteria.

The two steps will be carried out by using the same blood sample.

GSD’s sensitive EIA Lyme screen is comprised of B. burgdorferi strains B31 and 2591, in addition to VIsE immunogenic lipoprotein for optimal performance.

Featuring a 15-15-15-minute incubation protocol, the kit is provided with ready-to-use controls.

Gold Standard Diagnostics president John Griffiths said: “We are excited to be among the first companies to offer a complete Lyme testing solution that follows the CDC criteria and uses state-of-the-art technology.

“Our advanced assays will help to improve the diagnosis of Lyme disease, which is often under- or misdiagnosed.”

According to the CDC, Lyme disease is the fastest growing vector-borne infectious disease in the US. It also added that the current estimations of clinician-diagnosed Lyme disease is around 329,000 cases per year.

With more cases concentrated on the East Coast and in the Midwest, Lyme disease is most prevalent in the summer.

A vector-borne disease will be transmitted to people by blood-sucking insects and arachnids such as mosquitoes, fleas and ticks.

The new EIA kit offers GSD clients with a complete solution for Lyme testing, beside the firm’s Immunoblot kits for Lyme confirmation testing.

Gold Standard Diagnostics is engaged in the development, manufacturing and distribution of instrumentation and diagnostic test kits to clinical laboratories in the US, EMEA, Asia, and South America.

The company offers Thunderbolt and Bolt open format instrumentation platforms for enzyme and chemiluminescence immunoassays, as well as extended menu of serology tests across autoimmune, infectious, and endocrine diseases.


Image: The CDC estimates around 329,000 Lyme disease cases are diagnosed per year. Photo: courtesy of Business Wire.