OSPA NEGATIVE ELISA FOR LYME DISEASE

一种新的酶联免疫吸附试验（ELISA），以帮助诊断莱姆病。新的ELISA将使用缺乏外表面蛋白（Osp）A的伯氏疏螺旋体作为抗原（deltaOspA-B）。burgdorferi）。一种基于OspA的重组人莱姆病疫苗最近被FDA专家组推荐批准。疫苗接受者产生OspA抗体，并在当前的莱姆病ELISA中测试血清阳性，该ELISA使用B的全细胞裂解物。表达OspA的burgdorferi。迫切需要一种参考实验室ELISA来区分OspA疫苗接种与B疫苗接种。伯氏感染我们将首先生产大量的deltaOspA-B。burgdorferi，其将用于新的ELISA中。将deltaOspA-B burgdorferi ELISA的灵敏度和特异性与当前标准品B进行比较。使用来自莱姆病和可导致与B交叉反应的疾病患者的血清的伯氏全细胞裂解物ELISA。burgdorferi。 然后，我们将测试OspA疫苗接种者的血清，包括随后发展为B的个体。伯氏感染我们预期新的deltaOspA- B. burgdorferiELISA，而不是目前的ELISA，将区分感染和免疫，并且随着OspA疫苗的广泛使用，deltaOspA-B. BurgdorferiELISA将取代目前的B。基于burgdorferi全细胞裂解物的测定。拟议的商业应用：这项研究将导致一个血清学ELISA诊断人类莱姆病用于商业参考实验室。

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.