DIAGNOSTIC AND RESEARCH REAGENTS FOR HHV-8

本项目旨在开发检测人类疱疹病毒8型的诊断和研究试剂，人类疱疹病毒8型是艾滋病相关恶性肿瘤、卡波西S肉瘤和体腔淋巴瘤的病原体。这项提案是在快速通道上提交的，第一阶段有以下具体目标：[1]针对HHV-8的兔多克隆抗体将具有潜在的研究和诊断应用的特征；[2)构建用于鉴定抗HHV8抗体识别的蛋白质的表达cDNA文库；以及[3]将克隆、鉴定、体外扩增ORF65特异性的单抗，并对其潜在的商业化进行比较评估。这项工作将验证初步研究，这些研究表明抗体和病毒试剂的用途已经被开发为概念证据，证明它们可以在第二阶段工作期间进一步开发成商业产品。整个项目的交付成果将是针对疑似HHV-8患者、献血者和组织捐赠者的诊断试剂盒，以及用于HHV-8复制研究的试剂。拟议的商业应用诊断ELISA检测试剂盒将被开发用于检测可能感染HHV-8的患者或检测献血者和献血者。抗体和其他研究试剂将被开发为研究HHV-8复制的工具。

This project has the purpose of developing diagnostic and research reagents for assaying human herpes virus type 8 (HHV-8), the causative agent of the AIDS-associated malignancies, Kaposi s sarcoma and body cavity-based lymphoma. The proposal is being submitted on the Fast-Track, with Phase I having the following Specific Aims: [1] HHV-8-specific rabbit polyclonal antibody will be characterized for potential research and diagnostic applications; [2] The construction of an expression cDNA library for the identification of proteins recognized by the anti-HHV8 antibody; and [3] ORF65-specific monoclonal antibodies will be cloned, characterized, expanded in vitro and comparatively evaluated for potential commercialization. The work will validate preliminary studies showing the utility of the antibody and viral reagents which have already been developed as proof-of- concept that they can be further developed into commercial products during the Phase II work. The deliverable outcomes of the overall project will be diagnostic test kits for suspected HHV-8 patients, and blood and tissue donors, as well as reagents for research studies of HHV-8 replication. PROPOSED COMMERCIAL APPLICATION Diagnostic ELISA test kits will be developed for testing patients potentially infected with HHV-8 or to test blood and tissue donors. Antibodies and other research reagents will be developed as tools to study HHV-8 replication.