Removal · field guidance

Hospital-grade vs commercial-lab Lyme tests

FDA-cleared, CLIA-certified lab tests are reliable; non-validated panels (urine antigen, lymphocyte transformation, in-house assays) are not.

Steps

schema.org/HowTo

01
Verify the lab is CLIA-certified and the assay is FDA-cleared.
02
Prefer FDA-cleared two-tier or modified two-tier algorithms.
03
Avoid Lyme urine antigen tests, lymphocyte transformation assays, and CD57 panels — none are validated.
04
Be cautious of labs that interpret atypical bands as positive outside CDC criteria.
05
Discuss results with a clinician familiar with the validated algorithms.

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