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FDA Public Health Advisory

Assays for Antibodies to Borrelia burgdorferi; Limitations, Use, and Interpretation for Supporting a Clinical Diagnosis of Lyme Disease

July 7, 1997

Purpose
FDA is advising you about the potential for misdiagnosis of Lyme disease. The results of commonly marketed assays for detecting antibody to Borrelia burgdorferi (anti-Bb), the organism that causes Lyme disease, may be easily misinterpreted. To reduce this risk of misdiagnosis we are providing guidance on the use and interpretation of these tests. It is important that clinicians understand the limitations of these tests. A positive result does not necessarily indicate current infection with B. burgdorferi, and patients with active Lyme disease may have a negative test result.1-5

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