164. Evaluation of the VIDAS Lyme IgG Assay as a Test to Aid in the Diagnosis of Lyme Disease by Detection of B. burgdorferi IgG Antibodies
Session: Poster Abstract Session: Diagnostic Microbiology
Thursday, October 18, 2012
Room: SDCC Poster Hall F-H
Posters
  • LCR 12-0545 Art AP IDSA IgG Poster.pdf (531.9 kB)
  • Background: The VIDAS® Lyme IgG (LYG) assay is an automated qualitative test for use in the presumptive detection of human IgG antibodies to Borrelia burgdorferi in serum or plasma.  The sensitivity and specificity of the LYG assay were determined and compared to the BioRad® Platelia Lyme IgG assay (Platelia).  Evaluation of precision was also performed.

    Methods: The sensitivity of the LYG assay was established using 202 subjects with confirmed cases of Lyme disease composed of 119 early localized, single EM (stage I), 61 early disseminated, multiple EM (stage II) and 22 late disseminated: arthritis, neuroborreliosis (stage III) disease samples.  Stage I and II samples were further subcategorized by the day the sample was collected post-onset of symptoms.  The specificity of the assay was established in apparently healthy individuals from endemic (n=100) and non-endemic (n=100) regions of the US. The precision of the LYG assay was evaluated according to the CLSI EP5-A2 guideline.  Each precision panel sample was tested in duplicate on each of 20 days with 2 runs per day on 3 VIDAS systems (n= 240 per sample).      

    Results: The LYG assay demonstrated overall sensitivity of 64.4% and sensitivities of 49.6%, 83.6%, and 90.9% for subjects with stage I, II, and III disease, respectively.  The Platelia assay had an overall sensitivity of 49.5% and sensitivities for stages I, II, and III, of 42.9%, 54.1%, and 72.7%, respectively.  The LYG assay demonstrated specificities of 97.0% and 100.0% in endemic and non-endemic populations, respectively, while the Platelia assay demonstrated specificities of 97.0% and 98.0% in these populations.  The LYG assay demonstrated %CVs for total precision of 15.5%, 15.5%, 7.7%, and 5.3% for negative, high negative, low positive and high positive samples. 

    Conclusion:   The LYG assay exhibited good precision for determination of the anti-Lyme IgG status of samples.  The sensitivity results showed seropositivity rates approximating the known characteristics of the IgG response to B. burgdorferi antigens.  The sensitivity and specificity of the LYG assay were statistically equal to or better than the Platelia assay. The LYG assay provides rapid (27 minutes), automated detection of anti-Lyme IgG antibodies in support of the diagnosis of Lyme disease.

    Gary P. Wormser, MD1, Barbara A. Body, PhD2, Stephen A. Young, PhD3, E. Joy Rivers, PhD4 and Bernard J. Rice, BS4, (1)New York Medical College, Valhalla, NY, (2)LabCorp, Burlington, NC, (3)Microbiology/Virology, TriCore Reference Laboratories, Albuquerque, NM, (4)Clinical Affairs, bioMerieux, Inc., Durham, NC

    Disclosures:

    G. P. Wormser, Biomerieux: Grant Investigator, Research grant
    Immunetics: Grant Investigator, Research grant
    BioRad: Grant Investigator, Research grant
    Diasorin: Grant Investigator, Research grant

    B. A. Body, bioMerieux: Research Contractor, LabCorp receives all remuneration
    Becton Dickinson: Research Contractor and Scientific Advisor, LabCorp receives all remuneration
    Laboratory Corporation of America Holdings: Employee and Officer of the Company (Vice President), Employee benefits and Salary

    S. A. Young, bioMerieux: Investigator, Salary and Salary support for the technologists/supplies

    E. J. Rivers, bioMerieux, Inc.: Employee, Salary

    B. J. Rice, bioMerieux, Inc.: Employee, Salary

    Findings in the abstracts are embargoed until 12:01 a.m. PST, Oct. 17th with the exception of research findings presented at the IDWeek press conferences.