The result was a 2-tiered serologic testing protocol, which retained the poorly specific but reasonably sensitive assays of the time-EIAs or indirect fluorescence antibody (IFA) tests-as first-tier tests. The imperative at the 1994 Dearborn Conference was to address the poor specificity of serologic assays being used at the time, and to improve reproducibility by developing test performance and interpretation guidelines. The methodology applies similarly to Europe.ĬURRENT APPROACH: STRENGTHS AND LIMITATIONS We focus on the US situation, because serologic testing is performed using uniform methods and interpretive criteria, making comparisons with alternative methods more straightforward. We emphasize serologic test insensitivity during the first several weeks of infection, and the technical and interpretive complexity of Western immunoblots. The current report is limited to indirect detection serologic tests, as they are the standard for diagnostic testing, and improvements to existing recommendations are more adoptable for immediate use. Direct detection methods, designed to detect the infectious agent itself, were discussed along with indirect detection methods, which detect the host’s immunologic response to infection. The conference included members of academia, industry, and public health agencies. The article was developed after a 2016 Cold Spring Harbor Laboratory Banbury conference on the same subject. This is distinct from discussions about appropriate indications for the use of validated tests-that is, the question of when to request an assay for Lyme disease, or when testing is not needed. This article focuses on the technical aspects of current and near-at-hand platforms and assays for the laboratory diagnosis of Lyme disease. With the advent of whole-genome sequencing, and progress in mapping of immunodominant specific antigens, better-performing assays are being developed and some are at hand. In the interim, technological advances have surmounted some of the drawbacks of earlier assay platforms, but other important limitations remain. More than 2 decades later, despite drawbacks, this approach remains the standard for laboratory diagnosis of Lyme disease. To address this, the 1994 Conference on the Serological Diagnosis of Lyme Disease in Dearborn, Michigan, established a 2-tiered testing paradigm for serodiagnosis: a sensitive first-tiered test, now usually an enzyme immunoassay (EIA), followed by Western immunoblotting to increase specificity. After identification of the etiologic agent in 1983, antibody tests were developed, but specificity and reproducibility were poor. The annual incidence in the United States is approximately 300000 cases, with more than 3 million diagnostic tests performed each year. Lyme disease, the most common vector-borne illness in North America and Europe, is caused by tick-borne bacteria of the Borrelia burgdorferi sensu lato group. This article describes next-generation serodiagnostic testing for Lyme disease, focusing on methods that are currently available or near-at-hand. Next-generation serologic assays, prepared with recombinant proteins or synthetic peptides, and alternative testing protocols, can now overcome or circumvent many of these past drawbacks. Nevertheless, 2-tiered testing with immunoblotting remains the benchmark for evaluation of new methods or approaches. Additional drawbacks, particular to the Western immunoblot component, include low sensitivity in early infection, technical complexity, and subjective interpretation when scored by visual examination. burgdorferi, lacking key in vivo expressed antigens and expressing antigens that can bind non- Borrelia antibodies. These assays were prepared from whole-cell cultured B. A 2-tiered testing protocol was established for serodiagnosis in 1994, involving an enzyme immunoassay (EIA) or indirect fluorescence antibody, followed (if reactive) by immunoglobulin M and immunoglobulin G Western immunoblots. The cause of Lyme disease, Borrelia burgdorferi, was discovered in 1983.

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