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

Division of Infectious Diseases, New York Medical College, Valhalla, NY 10595, USA. Electronic address: .
Diagnostic microbiology and infectious disease (Impact Factor: 2.46). 10/2012; 75(1). DOI: 10.1016/j.diagmicrobio.2012.09.003
Source: PubMed


BACKGROUND: 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. METHODS: The diagnostic accuracy of a single-tier commercial C6 ELISA kit was compared with 2-tier testing. RESULTS: 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). CONCLUSIONS: 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.

Download full-text


Available from: John Stephen Dumler, Nov 18, 2015
1 Follower
25 Reads
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Current serodiagnostic assays for Lyme disease are inadequate at detecting early infection due to poor sensitivity and non-specificity that arise from the use of whole bacteria or bacterial proteins as assay targets; both targets contain epitopes that are cross-reactive with epitopes found in antigens of other bacteria species. Tests utilizing peptides that containing individual epitopes highly-specific for Borrelia burgdorferi as diagnostic targets are an attractive alternative to current assays. Using an overlapping peptide library, we mapped linear epitopes in OspC, a critical virulence factor of B. burgdorferi required for mammalian infection, and confirmed the results by ELISA. We identified a highly conserved 20-amino acid peptide epitope, OspC1. Via ELISA, OspC1 detected specific IgM and/or IgG in 60 out of 98 serum samples (62.1%) obtained from patients with erythema migrans (early Lyme disease) at the time of their initial presentation. By comparison, the commercially available OspC peptide, PepC10, detected antibody in only 48 of 98 serum samples (49.0%). In addition, OspC1 generated fewer false positive results among negative healthy and disease (rheumatoid arthritis and RPR+) control populations compared to PepC10. Both highly specific and more sensitive than currently available OspC peptides, OspC1 could have value as a component of a multi-peptide Lyme disease serological assay with significantly improved capabilities for the diagnosis of early infection.
    Clinical and vaccine Immunology: CVI 01/2013; 20(4). DOI:10.1128/CVI.00608-12 · 2.47 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Infections affecting frequently the nervous system include Lyme disease, tick-borne encephalitis and syphilis. These three most dreaded neuro-infectious diseases observed in Switzerland are discussed, based on diagnostic criteria, screening testing, and treatments modalities. Neuroborreliosis and neurosyphilis are bacterial infectious diseases treatable by antibiotics, whereas the treatment of tick-borne encephalitis, a viral disease, is only based on preventive vaccination.
    Revue médicale suisse 05/2013; 9(384):922, 924-8.
  • Article: The reply.

    The American journal of medicine 08/2013; 126(8):e17-8. DOI:10.1016/j.amjmed.2013.05.006 · 5.00 Impact Factor
Show more