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From the Centers for Disease Control and Prevention
April 20, 2005

Notice to Readers: Caution Regarding Testing for Lyme Disease

JAMA. 2005;293(15):1853. doi:10.1001/jama.293.15.1853

MMWR. 2005;54:125

CDC and the Food and Drug Administration (FDA) have become aware of commercial laboratories that conduct testing for Lyme disease by using assays whose accuracy and clinical usefulness have not been adequately established. These tests include urine antigen tests, immunofluorescent staining for cell wall–deficient forms of Borrelia burgdorferi, and lymphocyte transformation tests. In addition, some laboratories perform polymerase chain reaction tests for B. burgdorferi DNA on inappropriate specimens such as blood and urine or interpret Western blots using criteria that have not been validated and published in peer-reviewed scientific literature. These inadequately validated tests and criteria also are being used to evaluate patients in Canada and Europe, according to reports from the National Microbiology Laboratory, Public Health Agency of Canada; the British Columbia Centres for Disease Control, Canada; the German National Reference Center for Borreliae; and the Health Protection Agency Lyme Borreliosis Unit of the United Kingdom.

In the United States, FDA has cleared 70 serologic assays to aid in the diagnosis of Lyme disease. Recommendations for the use and interpretation of serologic tests have been published previously.1 Initial testing should use an enzyme immunoassay (EIA) or immunofluorescent assay (IFA); specimens yielding positive or equivocal results should be tested further by using a standardized Western immunoblot assay. Specimens negative by a sensitive EIA or IFA do not need further testing. Similar assays and recommendations are used in Canada.2 In the European Union, a minimum standard for commercial diagnostic kits is provided by Conformité Européene (CE) marking; application and interpretation guidelines appropriate for Europe have been published.3,4

Health-care providers are reminded that a diagnosis of Lyme disease should be made after evaluation of a patient’s clinical presentation and risk for exposure to infected ticks, and, if indicated, after the use of validated laboratory tests. Patients are encouraged to ask their physicians whether their testing for Lyme disease was performed using validated methods and whether results were interpreted using appropriate guidelines.

 Recommendations for test performance and interpretation from the Second National Conference on Serologic Diagnosis of Lyme Disease.  MMWR Morb Mortal Wkly Rep1995;44:590-1PubMed
 Consensus Conference on Lyme Disease.  Can Dis Wkly Rep. 1991;17:63-70PubMed
Wilske B, Zöller L, Brade V.  et al.  MIQ 12 Lyme-Borreliose. Qualitätsstandards in der mikrobiologisch-infektiologischen Diagnostik. Munich, Germany: Urban & Fischer Verlag; 2000;1-59. Guidelines available in English at http://nrz-borrelien.lmu.de/miq-lyme/index.html
Robertson J, Guy E, Andrews N.  et al.  A European multicenter study of immunoblotting in serodiagnosis of Lyme borreliosis.  J Clin Microbiol. 2000;38:2097-2102PubMed