Numerous concerns regarding the potential for misdiagnosis of Lyme disease
using commercial assays have been voiced by the US Food and Drug Administration
(FDA). We attempted to clarify the clinical value of serologic testing for
Lyme disease using the results of commonly marketed assays for detecting antibody
toBorrelia burgdorferi, the organism that causes
Lyme disease. We reviewed published studies on B burgdorferi test performance published through 1998, package insert labeling from
FDA-cleared test kits for B burgdorferi, and Lyme
Disease Survey Set LY-A from the College of American Pathologists. We assessed
the sensitivity and specificity of commercial serologic tests (enzyme-linked
immunosorbent assay [ELISA], immunofluorescence antibody [IFA], and immunodot)
for diagnosis of Lyme disease. To reduce this risk of misdiagnosis, it is
important that clinicians understand the performance characteristics and limitations
of these tests. These tests, in common use in clinical or commercial laboratories,
should be used only to support a clinical diagnosis of Lyme disease, not as
the primary basis for making diagnostic or treatment decisions. Serologic
testing is not useful early in the course of Lyme disease because of the low
sensitivity of tests in early disease. Serologic testing may be more useful
in later disease, at which time sensitivity and specificity of the test are
improved. Positive or equivocal results on an ELISA, IFA, or immunodot assay
requires supplemental testing with a Western blot assay. A negative result
on the Western blot or ELISA indicates that there is no serologic evidence
of infection by B burgdorferi at the time the sample
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Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal
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The Rational Clinical Examination
Make the Diagnosis: Erythema Migrans
The Rational Clinical Examination
Original Article: Does This Patient Have Erythema Migrans?
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