RECOMBINANT ELISA & IMMUNOBLOT ASSAYS FOR LYME DISEASE

该项目的长期目标是生产基于重组的 将提高准确性并降低成本的诊断分析 莱姆病检测。在证明了重组嵌合体 含有免疫优势伯氏疏螺旋体抗原的蛋白质可以 临床确诊患者血清中疏螺旋体特异性抗体的检测 莱姆病患者的敏感度和 特指，Brook BioTechnologies建议开发商业测试 基于这些嵌合蛋白的试剂盒。提出的方法首先是 基于两个嵌合体的组合来表征ELISA；第二到 标准化和验证生产商业化验的GMP流程 工具包；第三，测试商业广告的能力和局限性 试剂盒的形式根据FDA的指导方针；第四，开发、标准化 并验证了基于重组蛋白的一步免疫印迹分析 和/或Chimers。建议的研究将支持510(K)计划，以 FDA处于第三阶段，导致注册和批准上市 在美国的产品。 建议的商业应用： 第二阶段研究计划将产生所需的大部分数据 支持向FDA提交510(K)以供批准将其推向市场 重组酶联免疫吸附试验和免疫印迹试验。Brook BioTechnologies预计将 在1998年底提交此文档，并开始营销 1999年的产品。有超过500万次的酶联免疫吸附试验和 对疏螺旋体感染进行了50多万次免疫印迹检测 在美国，这个市场每年都在增长，而且预计还会继续增长。

The long term objective of this project is to produce recombinant-based diagnostic assays that will improve the accuracy and reduce the cost of testing for Lyme Disease. Having demonstrated that recombinant chimeric proteins containing immunodominant Borrelia burgdorferi antigens can detect Borrelia-specific antibodies in sera from clinically well defined Lyme disease patients with improvement in both sensitivity and specificity, Brook Biotechnologies proposes to develop commercial test kits based on these chimeric proteins. The approach proposed is first to characterize ELISAs based on a combination of two chimers; second to standardize and validate GMP processes for producing commercial assay kits; third to test the capabilities and limitations of the commercial form of the kits based on FDA guidelines; fourth to develop, standardize and validate a one-step immunoblot assay based on recombinant proteins and/or chimers. The studies proposed will support a 510(k) submission to FDA in Phase III, leading to registration and approval to market the products in the US. PROPOSED COMMERCIAL APPLICATION: The Phase II research program will produce most of the data required to support a 510(k) submission with FDA for approval to market the recombinant ELISA and immunoblot tests. Brook Biotechnologies expects to file this document at the end of 1998 and to begin marketing the products in 1999. There are greater than 5 million ELISA tests and greater than 500,000 iminunoblot tests for Borrelia infection performed annually in the US, and the market is expected to continue to grow.