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Evaluation of the recombinant VlsE-based liaison chemiluminescence immunoassay for detection of Borrelia burgdorferi and diagnosis of Lyme disease.

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Recent efforts to improve the serologic diagnosis of
Lyme disease have included the use of a synthetic peptide (C6) that reproduces the sequence of invariable region 6 of VlsE, the variable surface antigen of Borrelia burgdorferi. In the present study, the diagnostic performance of DiaSorin’s recombinant VlsE-based chemiluminescence immunoassay in 1,947 human serum samples was evaluated. Sensitivity was determined using two serum panels from the CDC. For panel I, we observed sensitivities of 68.4% and 75.6% for subjects with early, localized (n=19) or disseminated (n=41)
disease, respectively. For panel II, we observed sensitivities of 61.5% and 100% for subjects with early (n=26) or late-stage (n=11)
disease, respectively. We observed a specificity of 99.5% for healthy donors (n=600) living either in regions of the United States where the
disease is endemic or in regions where it is not endemic. Overall, specificity among 207 potentially cross-reactive sera from subjects who had other spirochetal infections, nonspirochetal infections including bacterial and viral infections, or autoimmune or neurologic
disease; who were positive for rheumatoid factor or anti-mouse antibodies; or who had been previously vaccinated for
Lyme disease was 93.7%. In a direct comparison of 1,038 prospectively collected samples for
Lyme disease testing we observed a relative sensitivity of 70%, a relative specificity of 99.1%, and an overall agreement of 97.1% between the DiaSorin recombinant VlsE chemiluminescence immunoassay and the Immunetics peptide-based C6 enzyme-linked immunosorbent assay.

Clin Vaccine Immunol. 2008 Dec;15(12):1796-804. doi: 10.1128/CVI.00195-08. Epub 2008 Oct 22. Evaluation Studies

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