Lyme Evidence Sheet
Reviewed 2026-07-24What is modified two-tier Lyme testing?
Modified two-tier testing uses two FDA-cleared antibody tests in sequence rather than an immunoblot. The full sequence and final laboratory interpretation still matter.
What the evidence says
- FDA cleared new indications for certain Lyme tests to support modified two-tier testing algorithms.
- CDC describes interpreting Lyme antibody testing as a two-step process.
What this can tell you
- Why two EIA-type results may appear on a report.
- What to ask about the final interpretation.
What this cannot tell you
- Whether one test name alone establishes a diagnosis.
- Whether a website can validate a laboratory workflow.
A useful question for your clinician
Was a modified two-tier algorithm used, and what is the final interpretation of both tests together?
Sources (2)
- U.S. Food and Drug Administration. ‘FDA Clears New Indications for Existing Lyme Disease Tests That May Help Streamline Diagnoses.’ July 29, 2019. https://www.fda.gov/news-events/press-announcements/fda-clears-new-indications-existing-lyme-disease-tests-may-help-streamline-diagnoses. Open source ↗
- Centers for Disease Control and Prevention. ‘Testing and Diagnosis for Lyme Disease.’ https://www.cdc.gov/lyme/diagnosis-testing/index.html. Accessed July 24, 2026. Open source ↗