OSPA NEGATIVE ELISA FOR LYME DISEASE

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A new enzyme-linked immunosorbent assay (ELISA) to aid in the diagnosis of Lyme disease. The new ELISA will use Borrelia burgdorferi that lack outer surface protein (Osp) A as antigen (deltaOspA-B. burgdorferi). A recombinant OspA-based human Lyme disease vaccine was recently recommended for approval by a FDA panel. Vaccine recipients develop OspA antibodies and test seropositive in the current Lyme disease ELISA, which uses whole-cell lysates of B. burgdorferi that express OspA. There is an immediate need for a reference laboratory ELISA to distinguish OspA-vaccination from B. burgdorferi infection. We will first produce large quantities of deltaOspA-B. burgdorferi, which will be used in the new ELISA. The sensitivity and specificity of the deltaOspA-b burgdorferi ELISA will be compared with the current standard B. burgdorferi-whole- cell-lysate ELISA suing sera from patients with Lyme disease, and diseases that can result in cross-reactivity with B. burgdorferi. We will then test sera from OspA vaccine recipients, including individuals that subsequently developed B. burgdorferi infection. We anticipate that the new deltaOspA- B. burgdorferi ELISA, and not the current ELISA, will distinguish infection from immunization, and that as the OspA vaccine becomes widely used, the deltaOspA-B. burgdorferi ELISA will supplant current B. burgdorferi whole-cell-lysate based assays. PROPOSED COMMERCIAL APPLICATIONS: This research will lead to a serologic ELISA diagnostic for human Lyme disease for use in commercial reference laboratories.