Journal Article

Effect of <i>Borrelia burgdorferi</i> Genotype on the Sensitivity of C6 and 2-Tier Testing in North American Patients with Culture-Confirmed Lyme Disease

Gary P. Wormser, Dionysios Liveris, Klára Hanincová, Dustin Brisson, Sara Ludin, Vincent J. Stracuzzi, Monica E. Embers, Mario T. Philipp, Andrew Levin, Aguero-Rosenfeld Maria and Ira Schwartz

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 47, issue 7, pages 910-914
Published in print October 2008 | ISSN: 1058-4838
Published online October 2008 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/591529
Effect of Borrelia burgdorferi Genotype on the Sensitivity of C6 and 2-Tier Testing in North American Patients with Culture-Confirmed Lyme Disease

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Background. A potential concern with any serologic test to detect antibodies to Borrelia burgdorferi is whether the epitopes incorporated in the test provide sufficient cross-reactivity to detect infection with all of the pathogenic strains of the species. This is a particular concern for the C6 test, which is based on reactivity to a single peptide.

Methods. C6 testing and 2-tier testing were performed on acute-phase serum samples obtained from >158 patients with erythema migrans for whom the genotype of the borrelial isolate was defined on the basis of an analysis of the 16S-23S ribosomal DNA spacer region and/or on the genetic variation of the outer surface protein C gene (ospC). The sonicated whole cell–based enzyme-linked immunosorbent assay, the immunoblots used in the 2-tier testing, and the C6 assay all used antigens from B. burgdorferi sensu stricto strain B31.

Results. The sensitivity of C6 testing (69.5%) was greater than that of 2-tier testing (38.9%) (P<.001); the difference in sensitivity, however, was statistically significant only for patients infected with 2 of the 3 ribosomal spacer type–defined genotypes. The lower sensitivity of 2-tier testing was attributable to the low sensitivity of the immunoblot tests, rather than the first-tier enzyme-linked immunosorbent assay. There was also a trend for the sensitivity of 2-tier testing to vary according to the ospC genotype for the 14 genotypes represented in the study ( P=.07); this relationship was not observed with C6 testing.

Conclusions. Lack of sensitivity of the C6 test because of strain diversity seems less likely to be a limitation of this serologic test, compared with 2-tier testing in North American patients with early Lyme disease.

Journal Article.  3692 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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