Lyme disease is a tickborne zoonosis for which serologic testing is the principal means of laboratory diagnosis. In 1994, the Association of State and Territorial Public Health Laboratory Directors, CDC, the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Council of State and Territorial Epidemiologists, and the National Committee for Clinical Laboratory Standards convened the Second National Conference on Serologic Diagnosis of Lyme Disease. The conference proceedings recommended a two-test methodology using a sensitive enzyme immunoassay (EIA) or immunofluorescence assay as a first test, followed by a western immunoblot assay for specimens yielding positive or equivocal results. The conference also advised that evaluation of new serologic assays include blind testing against a comprehensive challenge panel, and that new assays should only be recommended if their specificity, sensitivity, and precision equaled or surpassed the performance of tests used in the recommended two-test procedure. CDC, with support from NIH, has made available a comprehensive panel of sera from patients with various stages of Lyme disease and other conditions, as well as healthy persons.
On July 29, 2019, FDA cleared several Lyme disease serologic assays for use in a new testing paradigm in which two enzyme immunoassays are run concurrently or sequentially. FDA granted clearance to ZEUS Scientific for their ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System, ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System, ZEUS ELISA Borrelia burgdorferi IgM Test System, and the ZEUS ELISA Borrelia burgdorferi IgG Test System.
References
Association of State and Territorial Public Health Laboratory Directors. In: proceedings of the Second National Conference on Serologic Diagnosis of Lyme Disease; October 27–29, 1994; Dearborn, MI. Washington, DC: Association of State and Territorial Public Health Laboratory Directors; 1994.
CDC. Notice to readers: recommendations for test performance and interpretation from the Second National Conference on Serologic Diagnosis of Lyme Disease. MMWR Morb Mortal Wkly Rep 1995;44:590–1. PubMedexternal icon
Molins CR, Sexton C, Young JW, et al. Collection and characterization of samples for establishment of a serum repository for Lyme disease diagnostic test development and evaluation. J Clin Microbiol 2014;52:3755–62. CrossRefexternal icon PubMedexternal icon
Food and Drug Administration. FDA clears new indications for existing Lyme disease tests that may help streamline diagnoses. [News release]. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2019. https://www.fda.gov/news-events/press-announcements/fda-clears-new-indications-existing-lyme-disease-tests-may-help-streamline-diagnosesexternal icon
Mead P, Petersen J, Hinckley A. Updated CDC Recommendation for Serologic Diagnosis of Lyme Disease. MMWR Morb Mortal Wkly Rep 2019;68:703. DOI:http://dx.doi.org/10.15585/mmwr.mm6832a4