Dr. Leona Gilbert explains global standards for Lyme disease testing, including ISO, CAP, CLIA, FDA regulations, and why sensitivity and specificity matter for accurate diagnosis. Learn how lab quality affects patient outcomes and chronic infection detection.

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In this episode of LymeBytes!, Dr. Maria Hinchey welcomes Dr. Leona Gilbert, Docent of Cell and Molecular Biology and CEO of Tezted, to discuss global standards for Lyme disease and other vector-borne disease testing.

Dr. Gilbert explains the complexities of Borrelia testing, including how the bacteria’s low abundance, slow growth, and immune-evading behavior make chronic Lyme disease hard to detect. She breaks down international and U.S. standards for test kits and laboratories—ISO 13485 and 15189, CAP, CLIA, FDA Cleared, and FDA Approved—and why these standards matter for patient safety, legal acceptance, and minimizing misdiagnosis.

Listeners will learn the importance of sensitivity and specificity, how to interpret test results in the context of chronic infections, and why a Lyme diagnosis is ultimately clinical rather than solely lab-based. Dr. Gilbert also highlights the upcoming Conference of Chronic Infection Pathologies (CIPP) in Jyväskylä, Finland, focused on chronic infections including tick-borne diseases and COVID.

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Dr. Leona Gilbert, PhD, is a Docent of Cell and Molecular Biology and CEO of Tezted. She specializes in diagnostic accuracy, test kit manufacturing standards, and quality assurance for Lyme and other vector-borne diseases, helping patients and clinicians navigate complex testing landscapes.

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Dr. Leona Gilbert, PhD

Website: https://www.tezted.com/leona-gilbert 

Instagram: https://www.instagram.com/dr_leona_gilbert/ 

Linkedin: https://www.linkedin.com/in/leonagilbert/ 

Facebook: https://www.facebook.com/tickplex 

X: https://x.com/tez_ted

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Myriah Hinchey, ND, FMAPS

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