July 7, 1999

Lyme Disease SerologyProblems and Opportunities

Author Affiliations

Author Affiliations: Division of Infectious Diseases (Drs Wormser and Nadelman) and the Departments of Medicine and Pathology (Dr Aguero-Rosenfeld), New York Medical College, Valhalla.

JAMA. 1999;282(1):79-80. doi:10.1001/jama.282.1.79

Serologic assays for Lyme disease, first used in 1983,1 are widely ordered in the United States, with an estimated 2.8 million tests performed annually.2 High demand undoubtedly has provided a potent stimulus for the development and marketing of a large number of assays for detection of antibody to Borrelia burgdorferi. As reported by Brown and colleagues3 of the Food and Drug Administration (FDA) in this issue of THE JOURNAL, 45 first-step assays, including enzyme-linked immunosorbent assays (ELISAs), immunofluorescent assays (IFAs), or immunodot techniques, and 8 second-step (supplemental) immunoblot assays have been granted FDA approval. Given the tremendous interest in these tests, it is important for physicians, other health care professionals, and the public to appreciate the strengths and limitations of these tests so that they are used in a helpful way. Brown and colleagues have addressed many of these issues in their article.

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