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Clinical and Vaccine Immunology, October 2008, p. 1519-1522, Vol. 15, No. 10
1071-412X/08/$08.00+0     doi:10.1128/CVI.00109-08
Copyright © 2008, American Society for Microbiology. All Rights Reserved.

Impact of Clinical Variables on Borrelia burgdorferi-Specific Antibody Seropositivity in Acute-Phase Sera from Patients in North America with Culture-Confirmed Early Lyme Disease{triangledown}

Gary P. Wormser,1* John Nowakowski,1 Robert B. Nadelman,1 Paul Visintainer,2 Andrew Levin,3 and Maria E. Aguero-Rosenfeld4

Department of Pathology,4 Department of Medicine, Division of Infectious Diseases, New York Medical College, Valhalla, New York 10595,1 Department of Biostatistics, School of Public Health, New York Medical College, Valhalla, New York 10595,2 Immunetics, Inc., Boston, Massachusetts3

Received 27 March 2008/ Returned for modification 8 May 2008/ Accepted 25 July 2008

Erythema migrans, the most common manifestation of Lyme disease, has been associated with highly variable rates of seropositivity for antibodies to Borrelia burgdorferi. Differences in the sensitivities of serologic assays for the detection of these antibodies, however, may not be the only or even the primary explanation for this observation. We investigated the impacts of four clinical variables on seropositivity—the duration of erythema migrans, the presence of single versus multiple skin lesions, and the gender and age of the patient. In this analysis, three different serologic tests were performed on acute-phase sera from 175 untreated patients with culture-confirmed erythema migrans: the C6 single-peptide enzyme-linked immunosorbent assay (ELISA), a commercially available ELISA in which a whole-cell sonicate of B. burgdorferi was the antigen, and a two-tier procedure. Irrespective of the serologic test performed, the results showed that seropositivity rates increased with the duration of the erythema migrans for patients with single lesions (P < 0.001) but not for those with multiple skin lesions. The variability in seropositivity rates was greatest for the two-tier testing strategy, with a >6-fold-higher rate of seropositivity among patients with a single lesion of 22- to 30-day duration than among those whose skin lesion was of 1- to 7-day duration (85.7 versus 14.1%; P < 0.001). Rates of seropositivity by each of the testing methods were also significantly higher for patients with multiple skin lesions than for those with single lesions (P < 0.001). In contrast, seropositivity rates were not affected by either the gender or the age of the patient. Thus, in patients with erythema migrans, certain clinical variables such as the duration and number of skin lesions had a profound impact on seropositivity rates, irrespective of the serologic assay performed.

* Corresponding author. Mailing address: Division of Infectious Diseases, Munger Pavilion Room 245, New York Medical College, Valhalla, NY 10595. Phone: (914) 493-8865. Fax: (914) 493-7289. E-mail: gary_wormser{at}nymc.edu

{triangledown} Published ahead of print on 20 August 2008.

Clinical and Vaccine Immunology, October 2008, p. 1519-1522, Vol. 15, No. 10
1071-412X/08/$08.00+0     doi:10.1128/CVI.00109-08
Copyright © 2008, American Society for Microbiology. All Rights Reserved.





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