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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 (<jats:italic>n<\/jats:italic>= 19) or disseminated (<jats:italic>n<\/jats:italic>= 41) disease, respectively. For panel II, we observed sensitivities of 61.5% and 100% for subjects with early (<jats:italic>n<\/jats:italic>= 26) or late-stage (<jats:italic>n<\/jats:italic>= 11) disease, respectively. We observed a specificity of 99.5% for healthy donors (<jats:italic>n<\/jats:italic>= 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.<\/jats:p>","DOI":"10.1128\/cvi.00195-08","type":"journal-article","created":{"date-parts":[[2008,10,23]],"date-time":"2008-10-23T00:58:12Z","timestamp":1224723492000},"page":"1796-1804","update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":43,"title":["Evaluation of the Recombinant VlsE-Based Liaison Chemiluminescence Immunoassay for Detection of<i>Borrelia burgdorferi<\/i>and Diagnosis of Lyme Disease"],"prefix":"10.1128","volume":"15","author":[{"given":"Thomas B.","family":"Ledue","sequence":"first","affiliation":[{"name":"Foundation for Blood Research, Scarborough, Maine"},{"name":"Centers for Disease Control and Prevention, Diagnostics and Reference Section, Division of Vector-Borne Infectious Diseases, Ft. 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