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Journal of Clinical Microbiology, December 1999, p. 3990-3996, Vol. 37, No. 12
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.
Sensitive and Specific Serodiagnosis of Lyme
Disease by Enzyme-Linked Immunosorbent Assay with a Peptide Based
on an Immunodominant Conserved Region of Borrelia
burgdorferi VlsE
Fang Ting
Liang,1
Allen C.
Steere,2
Adriana R.
Marques,3
Barbara J. B.
Johnson,4
James N.
Miller,5 and
Mario T.
Philipp1,*
Department of Parasitology, Tulane Regional
Primate Research Center, Tulane University Medical Center, Covington,
Louisiana 70433;1 Division of
Rheumatology, New England Medical Center, Tufts University School of
Medicine, Boston, Massachusetts 021112;
National Institute of Allergy and Infectious Diseases, National
Institutes of Health, Bethesda, Maryland 208923;
Division of Vector-Borne Infectious Diseases, Centers for
Disease Control and Prevention, Fort Collins, Colorado
805224; and Department of Microbiology
and Immunology, University of California at Los Angeles, Los
Angeles, California 900955
Received 30 June 1999/Returned for modification 12 August
1999/Accepted 19 August 1999
VlsE, the variable surface antigen of Borrelia
burgdorferi, contains an immunodominant conserved region named
IR6. In the present study, the diagnostic performance of a
peptide enzyme-linked immunosorbent assay (ELISA) based on a 26-mer
synthetic peptide (C6) with the IR6 sequence
was explored. Sensitivity was assessed with serum samples
(n = 210) collected from patients with clinically defined Lyme disease at the acute (early localized or early
disseminated disease), convalescent, or late disease phase. The
sensitivities for acute-, convalescent-, and late-phase specimens were
74% (29 of 39), 85 to 90% (34 of 40 to 35 of 39), and 100% (59 of
59), respectively. Serum specimens from early neuroborreliosis patients were 95% positive (19 of 20), and those from an additional group of
patients with posttreatment Lyme disease syndrome yielded a sensitivity
of 62% (8 of 13). To assess the specificity of the peptide ELISA, 77 serum samples from patients with other spirochetal or chronic
infections, autoimmune diseases, or neurologic diseases and 99 serum
specimens from hospitalized patients in an area where Lyme disease is
not endemic were examined. Only two potential false positives from the
hospitalized patients were found, and the overall specificity was 99%
(174 of 176). Precision, which was assessed with a panel of positive
and negative serum specimens arranged in blinded duplicates, was 100%.
Four serum samples with very high anti-OspA antibody titers obtained
from four monkeys given the OspA vaccine did not react with the
C6 peptide. This simple, sensitive, specific, and precise
ELISA may contribute to alleviate some of the remaining problems in
Lyme disease serodiagnosis. Because of its synthetic peptide base, it
will be inexpensive to manufacture. It also will be applicable to serum
specimens from OspA-vaccinated subjects.
*
Corresponding author. Mailing address: Tulane Regional
Primate Research Center, Tulane University Medical Center, 18703 Three Rivers Rd., Covington, LA 70433. Phone: (504) 871-6221. Fax: (504) 871-6390. E-mail: philipp{at}tpc.tulane.edu.
Journal of Clinical Microbiology, December 1999, p. 3990-3996, Vol. 37, No. 12
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.
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