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.

Hot this week

Recor Medical Supports European Society of Cardiology’s Hypertension Guidelines

Record Medical notes the new guidelines, "2024 ESC Guidelines for the management of elevated blood pressure and hypertension," have been published online and recommend the consideration of renal denervation (RDN) as a safe and effective treatment option for patients who have uncontrolled resistant hypertension or those that have uncontrolled hypertension with a higher risk of cardiovascular disease, who express a preference to undergo RDN.

ConTIPI Medical Selects EVERSANA to Support U.S. Commercialization of Non-Surgical Medical Device ProVate for Women with Pelvic Organ Prolapse

EVERSANA is a leading provider of global commercial services to the life sciences industry, to support commercialization for the ProVate device in the United States to help women experiencing pelvic organ prolapse.

Boston Scientific Obtains CE Mark for ACURATE Prime Aortic Valve System

The ACURATE Prime aortic valve system is designed with several features to build upon the clinical performance of the ACURATE neo2™ platform including an additional valve size, which expands the treatment range to patients with a larger anatomy.

Noctrix Health Announces New CMS Reimbursement Codes and Payment for Nidra Tonic Motor Activation Therapy for Restless Legs Syndrome

Nidra TOMAC Tonic Motor Activation Therapy, which was authorized for marketing in the United States last year following its designation as a "Breakthrough Device" by the US Food & Drug Administration (FDA), remains the only clinically validated, non-pharmaceutical treatment available for patients with RLS.

Haemonetics Announces Full Market Release for VASCADE MVP® XL Vascular Closure System

Haemonetics notes the VASCADE MVP XL system is now available to U.S. hospitals as the newest addition to Haemonetics' VASCADE® portfolio of vascular closure systems featuring an innovative collapsible disc technology and a proprietary resorbable collagen patch designed to promote rapid hemostasis.