Laboratory tests and practices that are not currently recommended

CDC recommends using diagnostic tests for Lyme disease that have been cleared or approved by the U.S. Food and Drug Administration (FDA). Use of an FDA cleared or approved test provides assurance that the test has undergone adequate analytical and clinical validation and is safe and effective.

Some laboratories offer their own laboratory developed tests for Lyme disease whose clinical validity and safety have not been cleared or approved by the FDA. This means that information is lacking about the accuracy with which these tests identify, measure, or predict the presence or absence of Lyme disease in a patient. Examples include:

  • Capture assays for antigens in urine
  • Immunofluorescence staining, or cell sorting of cell wall-deficient or cystic forms of Borrelia burgdorferi
  • Lymphocyte transformation tests
  • Quantitative CD57 lymphocyte assays
  • “Reverse Western blots”
  • IgM or IgG blot assays without a previous enzyme immunoassay

Be aware that laboratories that do not accept private insurance may be offering tests that are not cleared or approved by the FDA.

Additional cautions:

  • If a laboratory uses “in-house” criteria for interpretation of FDA-cleared tests for Lyme disease, this indicates the laboratory has modified the test and the clinical validity and safety is not certain.
  • Test results for Lyme disease should always be interpreted in the broader context of a person’s illness and medical history, exposure likelihood, and other test results.
  • Do not seek testing without consulting a healthcare provider.