Single-tier testing with the C6 peptide ELISA kit compared with two-tier testing for Lyme disease

Gary P. Wormser, Martin Schriefer, Maria E. Aguero-Rosenfeld, Andrew Levin, Allen C. Steere, Robert B. Nadelman, John Nowakowski, Adriana Marques, Barbara J.B. Johnson, J. Stephen Dumler

Research output: Contribution to journalArticle

Abstract

For the diagnosis of Lyme disease, the 2-tier serologic testing protocol for Lyme disease has a number of shortcomings including low sensitivity in early disease; increased cost, time, and labor; and subjectivity in the interpretation of immunoblots. In this study, the diagnostic accuracy of a single-tier commercial C6 ELISA kit was compared with 2-tier testing. The results showed that the C6 ELISA was significantly more sensitive than 2-tier testing with sensitivities of 66.5% (95% confidence interval [CI] 61.7-71.1) and 35.2% (95% CI 30.6-40.1), respectively (P < 0.001) in 403 sera from patients with erythema migrans. The C6 ELISA had sensitivity statistically comparable to 2-tier testing in sera from Lyme disease patients with early neurologic manifestations (88.6% versus 77.3%, P = 0.13) or arthritis (98.3% versus 95.6%, P = 0.38). The specificities of C6 ELISA and 2-tier testing in over 2200 blood donors, patients with other conditions, and Lyme disease vaccine recipients were found to be 98.9% and 99.5%, respectively (P < 0.05, 95% CI surrounding the 0.6 percentage point difference of 0.04 to 1.15). In conclusion, using a reference standard of 2-tier testing, the C6 ELISA as a single-step serodiagnostic test provided increased sensitivity in early Lyme disease with comparable sensitivity in later manifestations of Lyme disease. The C6 ELISA had slightly decreased specificity. Future studies should evaluate the performance of the C6 ELISA compared with 2-tier testing in routine clinical practice.

Original languageEnglish (US)
Pages (from-to)9-15
Number of pages7
JournalDiagnostic Microbiology and Infectious Disease
Volume75
Issue number1
DOIs
StatePublished - Jan 1 2013

Keywords

  • Borrelia burgdorferi
  • C6 ELISA
  • Lyme disease
  • Serology

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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  • Cite this

    Wormser, G. P., Schriefer, M., Aguero-Rosenfeld, M. E., Levin, A., Steere, A. C., Nadelman, R. B., Nowakowski, J., Marques, A., Johnson, B. J. B., & Dumler, J. S. (2013). Single-tier testing with the C6 peptide ELISA kit compared with two-tier testing for Lyme disease. Diagnostic Microbiology and Infectious Disease, 75(1), 9-15. https://doi.org/10.1016/j.diagmicrobio.2012.09.003