Accuracy of IgM Immunoblotting to Confirm the Clinical Diagnosis of Early Lyme Disease

doi:10.1001/archinte.1996.00440170121013

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Vol. 156 No. 18, 14 OCTOBER 1996

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Accuracy of IgM Immunoblotting to Confirm the Clinical Diagnosis of Early Lyme Disease

Steven L. Sivak, MD; Maria E. Aguero-Rosenfeld, MD; John Nowakowski, MD; Robert B. Nadelman, MD; Gary P. Wormser, MD

Arch Intern Med. 1996;156(18):2105-2109.

Abstract

Background
A 2-test approach for the serologic diagnosis of Lyme diseasehas recently been proposed. A positive or equivocal result ona first-stage test (eg, an enzyme immunoassay) is followed bya Western immunoblot test. For a sample to be considered seropositivefor Lyme disease, the immunoblot result must be positive.

Objectives
To assess the accuracy of IgM immunoblotting for detection ofearly Lyme disease and to establish interpretative criteriafor a commercially available immunoblot assay.

Methods
Serum samples from 44 patients with erythema migrans were testedby an IgM immunoblot assay. All patients were culture-positivefor Borrelia burgdorferi. Serum samples from 2 different controlgroups were also tested. Interpretative criteria were developedusing receiver operating characteristic curves.

Results
The presence of any 2 IgM bands was found to be the optimalcriterion for a positive test result, and in patients with illnessof less than 7 days' duration, this was significantly more sensitivethan the criterion of any 2 of the 3 specific bands definedby the Centers for Disease Control and Prevention/Associationof State and Territorial Public Health Laboratory DirectorsLyme Disease Workgroup (P<.05). Specificity of the criterionof any 2 bands was 100% for 1 group of controls but only 96%for the more clinically relevant control group; this small differencehad a large impact on the positive predictive value in populationsat low risk for Lyme disease.

Conclusions
Using a commercially available immunoblot test kit, the presenceof any 2 IgM bands is proposed as a positive result. The predictivevalue of a positive IgM immunoblot result, however, is poorin patients with minimal clinical evidence for Lyme disease.

Arch Intern Med. 1996;156:2105-2109

Author Affiliations

From St Vincent's Hospital and Medical Center, New York, NY (Dr Sivak); Divisions of General Medicine (Dr Sivak) and Infectious Diseases (Drs Nowakowski, Nadelman, and Wormser), Department of Medicine, and Department of Pathology (Dr Aguero-Rosenfeld), New York Medical College, Valhalla; and Lyme Disease Diagnostic Center, Westchester County Medical Center, Valhalla (Drs Nowakowski, Nadelman, and Wormser).

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