Clinical Testing and Diagnosis for Lyme Disease

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Laboratory diagnosis of Lyme disease relies on serologic testing for antibodies to Borrelia burgdorferi. CDC recommends a two-step serologic testing process using FDA-cleared assays. Serologic assays may be falsely negative during the first 4-6 weeks after infection. Before CDC will recommend new tests, they must be cleared by the Food and Drug Administration (FDA).


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