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.
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.
Wormser GP, Aguero-Rosenfeld ME, Nadelman RB. Lyme Disease SerologyProblems and Opportunities. JAMA. 1999;282(1):79-80. doi:10.1001/jama.282.1.79