DEVELOPMENT OF A NOVEL HPV IDENTIFICATION SYSTEM

新型 HPV 识别系统的开发

• 批准号: 6376542
• 负责人: ANGUS G HEPBURN
• 金额: $ 34.72万
• 依托单位: PROFILE DIAGNOSTIC SCIENCES, INC.
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-04-01 至 2003-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6376542
• 关键词: cancer risk; cervix neoplasms; communicable disease diagnosis; diagnosis design /evaluation; early diagnosis; fluorescent dye /probe; fluorimetry; genetic strain; human papillomavirus; nucleic acid hybridization; nucleic acid sequence; oncogenic virus; recombinase; virus DNA; virus classification

Invasive carcinoma of the cervix is-one of the most common cancers in the world. Human papillomavirus (HPV), progressing through cervical intraepithelial neoplasia (CIN), is the primary causal agent for the development of invasive cervical cancer. However, of the 70 or more HPV subtypes, few progress to cancer. Although early detection coupled with eradication of cervical cancer precursors has been shown to lead to a decreased incidence of invasive cervical cancer, the present state of the art employs diagnostic techniques that are too costly or too time consuming to screen large populations efficiently. Accurate strain identification is presently only possible through cumbersome DNA hybridization analyses utilizing either Southern blot technology or in situ hybridization technology. In the following proposal, an enzyme-assisted, sequence- specific identification system will be developed. The simple, rapid, sensitive, accurate, and low-cost DNA diagnostic system described herein will detect HPV at very early stages of infection and will distinguish between low-oncogenic-risk strains and high-oncogenic-risk strains. This will enable large scale screening by establishing a diagnostic protocol that is sensitive, rapid, simple, and relatively inexpensive. The diagnostic tool described by this proposal is applicable in detection of other infectious diseases and genetic diseases with only simple modifications. PROPOSED COMMERCIAL APPLICATION: The proposal describes a rapid and inexpensive DNA diagnostic tool suitable for routine used which matches the specificity, accuracy and sensitivity of hybridization or PCR-based assays. In addition to the screening of HPV, the diagnostic tool described by this proposal is applicable in the detection of other infectious diseases and genetic diseases with only simple modification.

宫颈浸润性癌是世界上最常见的癌症之一。人乳头瘤病毒（HPV），通过宫颈上皮内瘤变（CIN）进展，是侵袭性宫颈癌发展的主要原因。然而，在70种或更多的HPV亚型中，很少进展为癌症。虽然早期发现加上根除子宫颈癌前体已被证明可降低浸润性子宫颈癌的发病率，但目前所采用的诊断技术过于昂贵或耗时，无法有效地对大量人群进行筛查。准确的菌株鉴定目前只能通过繁琐的DNA杂交分析，利用Southern blot技术或原位杂交技术。在下面的建议中，将开发一种酶辅助的序列特异性鉴定系统。本文描述的简单、快速、敏感、准确和低成本的DNA诊断系统将在感染的早期阶段检测HPV，并将区分低致癌风险株和高致癌风险株。这将通过建立一种敏感、快速、简单和相对廉价的诊断方案，使大规模筛查成为可能。本方案所描述的诊断工具，经过简单修改，也适用于其他传染病和遗传病的检测。拟议的商业应用：该提案描述了一种快速且廉价的DNA诊断工具，适合常规使用，其特异性，准确性和敏感性与杂交或基于pcr的检测相匹配。除了HPV的筛查外，本方案所描述的诊断工具只需进行简单的修改，也适用于其他传染病和遗传性疾病的检测。