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

October 5, 2020

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.

Gold Standard Diagnostics advises the assays are available immediately in the US.

The separate IgG and IgM assays provide laboratories the ability to offer more specificity in their Lyme screen algorithm. They are designed for optimal functionality in diagnostic laboratories with a total incubation time of 45 minutes at room temperature with ready-to-use controls. The kits can be run manually or on any open automated EIA platform.

While the world still grapples with COVID-19, many other medical conditions, including Lyme disease, are on the rise and are often undiagnosed. Experts have recently found, Americans infected with Lyme disease is ten times higher than what is reported by the CDC. What is more, symptoms of Lyme disease are so varied that it is often quite challenging to diagnose and can range from fever and headaches to irregular heartbeats, dizziness, and nerve pain. The GSD Lyme IgG and Lyme IgM EIA assays were made to provide antibody specific reliable information to the clinicians diagnosing this disease.

“We are witness to major changes in Lyme diagnostics. Our team of professionals are adapting and responding to these changes. New products are being produced to meet these new demands. GSD has an ever-expanding Lyme product menu to address and exceed laboratory expectations for Lyme and other tick-borne disease testing,” states Dr. Barry Menefee, Infectious Disease Specialist at GSD.

Traditional Lyme testing is our core. New and innovative Lyme testing will soon be available from GSD.

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