DIAGNOSTIC AND RESEARCH REAGENTS FOR HHV-8

本项目旨在开发检测人类疱疹病毒8型（HHV-8）的诊断和研究试剂，HHV-8是艾滋病相关恶性肿瘤、卡波西肉瘤和体腔淋巴瘤的病原体。该提案正在快速通道上提交，第一阶段有以下具体目标：[1]hhv -8特异性兔多克隆抗体将被表征为潜在的研究和诊断应用；[2]构建表达cDNA文库，用于鉴定抗hhv8抗体识别的蛋白；和[3]orf65特异性单克隆抗体将被克隆、鉴定、体外扩增和比较评估潜在的商业化。这项工作将验证初步研究的效用，这些抗体和病毒试剂已被开发为概念验证，可在第二期工作期间进一步发展为商业产品。整个项目的可交付成果将是用于疑似HHV-8患者、血液和组织捐献者的诊断测试试剂盒，以及用于研究HHV-8复制的试剂。拟议的商业应用诊断ELISA检测试剂盒将用于检测可能感染HHV-8的患者或检测血液和组织供者。抗体和其他研究试剂将被开发作为研究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.