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.
- 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.
- Concerns Regarding a New Culture Method for Borrelia burgdorferi Not Approved for the Diagnosis of Lyme Disease. MMWR, 2014;63:333
- Johnson BJ, Pilgard MA, Russell TM. Assessment of new culture method for detection of Borrelia species from serum of Lyme disease patients. J Clin Microbiol 2014;52:721–4.
- Notice to readers: caution regarding testing for Lyme disease. MMWR, CDC Surveillance Summary, 2005;54:125.
- Marques A, Brown MR, Fleisher TA: Natural killer cell counts are not different between patients with post-Lyme disease syndrome and controls. Clin Vaccine Immunol 2009;16:1249–1250.