Get FREE U.S. Shipping on $75 Orders*

Role of serology in the diagnosis of Lyme disease.

1 Star2 Stars3 Stars4 Stars5 Stars (No Ratings Yet)


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 to Borrelia 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 was drawn.

JAMA. 1999 Jul 7;282(1):62-6.

ProHealth CBD Store


1 Star2 Stars3 Stars4 Stars5 Stars (No Ratings Yet)

Leave a Reply