![]() The modified methodology uses a second EIA in place of a western immunoblot assay. On July 29, 2019, FDA cleared several Lyme disease serologic assays with new indications for use based on a modified two-test methodology ( 4). To assist serologic test developers, CDC has made available, with support from NIH, a comprehensive panel of sera from patients with various stages of Lyme disease and other conditions, as well as healthy persons ( 3). Regarding the development of future tests, the report 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. 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 ( 1, 2). 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 ( 1). ![]() ![]() Lyme disease is a tickborne zoonosis for which serologic testing is the principal means of laboratory diagnosis.
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