FDA Cleared Lyme Disease Tests - What This Means for Laboratories, Doctors, and Patients

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FDA Cleared Lyme Disease Tests - What This Means for Laboratories, Doctors, and Patients

Categories:

Wellness

Tick-Borne Disease

Date:

11/12/2025

Speaker:

Dr. Joseph Burrascano, MD

Join us for a webinar as we dive deep into the FDA-approved Lyme disease test kits. Learn what this means for laboratories, doctors, and patients.

Key features of the FDA-cleared kits
• Results interpretation is based upon new criteria and not CDC criteria.
• The bands are grouped according to their antigen groups. The test is considered positive if the Lyme Screen Antigen (LSA) band and one or more bands from at least two other groups are present on the ImmunoBlot.
• Bands 31 and 34 are included, making these the only FDA-cleared Lyme serological tests that include these bands.

Speaker: Dr. Joseph Burrascano, MD

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