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
Register and get free email Table of Contents alerts, saved searches, PowerPoint downloads, CME quizzes, and more
Subscribe for full-text access to content from 1998 forward and a host of useful features
Activate your current subscription (AMA members and current subscribers)
Purchase Online Access to this article for 24 hours
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
Thank you for submitting a comment on this article. It will be reviewed by JAMA editors. You will be notified when your comment has been published. Comments should not exceed 500 words of text and 10 references.
Do not submit personal medical questions or information that could identify a specific patient, questions about a particular case, or general inquiries to an author. Only content that has not been published, posted, or submitted elsewhere should be submitted. By submitting this Comment, you and any coauthors transfer copyright to the journal if your Comment is posted.
* = Required Field
Disclosure of Any Conflicts of Interest*
Indicate all relevant conflicts of interest of each author below, including all relevant financial interests, activities, and relationships within the past 3 years including, but not limited to, employment, affiliation, grants or funding, consultancies, honoraria or payment, speakers’ bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued. If all authors have none, check "No potential conflicts or relevant financial interests" in the box below. Please also indicate any funding received in support of this work. The information will be posted with your response.
Some tools below are only available to our subscribers or users with an online account.
Download citation file:
Web of Science® Times Cited: 67
Customize your page view by dragging & repositioning the boxes below.
More Listings atJAMACareerCenter.com >
The Rational Clinical Examination
Make the Diagnosis: Erythema Migrans
The Rational Clinical Examination
Original Article: Does This Patient Have Erythema Migrans?
All results at
and access these and other features:
Enter your username and email address. We'll send you a link to reset your password.
Enter your username and email address. We'll send instructions on how to reset your password to the email address we have on record.
Athens and Shibboleth are access management services that provide single sign-on to protected resources. They replace the multiple user names and passwords necessary to access subscription-based content with a single user name and password that can be entered once per session. It operates independently of a user's location or IP address. If your institution uses Athens or Shibboleth authentication, please contact your site administrator to receive your user name and password.