BACTERIAL BINDING PROTEIN FOR HUMAN IMMUNOGLOBULIN M

此第二阶段提案的目的是克隆和表征 负责编码细菌的IgM受体的基因。由此产生的 重组蛋白将在监测IgM抗体方面有应用 答复，并已应用于个人的早期识别 接触病原体、检测新生儿感染和使用 在各种免疫诊断测试中监测疾病进展。 此外，该试剂在固定化后可用于纯化IgM 抗体。 在第一阶段的研究中，我们开发了选择性分析技术来 筛选具有免疫球蛋白M结合潜能的大量分离株 导致确定了一些候选生物体，这些生物体将 用于第二阶段研究。使用选定的候选生物体，DNA 文库-将生成并筛选以确定编码基因 IgM结合蛋白。将确定IgM结合结构域并 一种适用于免疫技术的重组产品 精心设计的应用程序。 该项目的重点是开发一种细菌IgM受体以供使用 在作为亲和纯化试剂的各种诊断试剂中 以及用于监测IgM抗体反应的研究试剂。 商业化将是第三阶段的重点。 拟议的商业应用：一种人IgM结合蛋白，可以 在不影响抗体结合重链的情况下 BIND抗原将为研究和诊断提供关键试剂 免疫分析。一种可以检测到类似物中IgM的细菌蛋白 流行金黄色葡萄球菌蛋白A或链球菌蛋白G也会 在大规模提纯IgM方面具有广泛的商业应用 抗体。

The purpose of this Phase II proposal is to clone and characterize the gene responsible for encoding a bacterial IgM receptor. The resulting recombinant protein will have applications for monitoring IgM antibody responses and have applications for early identification of individuals exposed to pathogen, detection of infection in the newborn and for use in a variety of immunodiagnostic tests to monitor disease progression. In addition, the reagent, when immobilized, can be used to purify IgM antibodies. In the Phase I study we have developed selective assay techniques to screen a large number of isolates for IgM-binding potential which have led to identification of a number of candidate organisms which will he used in the Phase II studies. Using a selected candidate organism, DNA libraries-will be generated and screened to identify the gene encoding the IgM-binding protein. The IgM-binding domain will be identified and a recombinant product suitable for use in immunotechnological applications engineered. The focus of the project is to develop a bacterial IgM receptor for use in a wide variety of diagnostic kits as affinity purification reagents and research reagents for monitoring IgM antibody responses. Commercialization will be the focus of Phase III. PROPOSED COMMERCIAL APPLICATION: A human IgM-binding protein that could bind to the heavy chain without affecting the ability of the antibody to bind antigen would provide a key reagent for research and diagnostic immunoassays. A bacterial protein which could detect IgM in an analogous fashion to Staphylococcal protein A or Streptococcal protein G would also have broad commercial applications for large scale purification of IgM antibodies.