Point of Care Diagnostics of HPV-Associated Cervical Cancer in HIV Epidemic Areas in China

中国HIV流行区HPV相关宫颈癌的即时诊断

基本信息

批准号：
9246115
负责人：
Changchun Liu
金额：
$ 16万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-01-19 至 2021-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9246115
关键词：
Academy Acetic Acids Acquired Immunodeficiency Syndrome Area Biological Assay Car Phone Cellular Phone Cervical Cancer Screening Cessation of life Chemicals China Chinese People Clinical Collaborations Complex County DNA Detection Development Devices Diagnostic Diagnostic Procedure Epidemic Epidemiology Evaluation FDA approved Feedback General Population Genotype HIV HIV Seropositivity HPV-High Risk Health Personnel Heating High Prevalence Hospitals Human Characteristics Human Papillomavirus Human Resources Human papilloma virus infection Individual Institutes International Laboratories Malignant Neoplasms Malignant neoplasm of cervix uteri Medical Methods Molecular Diagnosis Morbidity - disease rate Nucleic Acid Hybridization Optics Pennsylvania Performance Point-of-Care Systems Province Reaction Reporting Reproducibility Research Research Infrastructure Research Personnel Resources Rural Sampling Science Sensitivity and Specificity Site Solid System Technology Temperature Testing Time Training Translating Treatment outcome Universities Vagina Validation Visual Woman Women&apos s Health base chemical reaction clinical application comparative cost design detector experience field study health care quality high risk improved improved outcome innovation instrument low and middle-income countries melting molecular diagnostics mortality multidisciplinary operation pandemic disease phase change point of care point-of-care diagnostics portability rapid detection stem tool viral detection

项目摘要

Abstract: Human papillomavirus (HPV)-associated cervical cancer is one of the most common acquired immunodeficiency syndrome (AIDS)-related malignancies. Cervical cancer is the second deadliest cancer in women around the world, and has currently become a major threat to Chinese women's health, especially in rural China and HIV epidemic areas. High-risk types of HPV are the causative agents of cervical cancer and WHO has recommended HPV testing for cervical cancer screening in low- and middle-income countries (LMICs), such as China. However, PCR-based HPV detection requires expensive PCR instruments and is unaffordable for widespread use in LMICs. Recently emerging careHPVTM test, based on nucleic acid hybridization detection, has offered comparatively simpler, less expensive and more portable HPV testing, but still has many shortcomings for point-of-care (POC) diagnostic applications, including: i) relatively long detection time (~3 h), ii) use by well-trained technicians, and iii) reliance on relatively expensive instruments. In collaboration with investigators at the Cancer Institute/Hospital, Chinese Academy of Medical Sciences (CICAMS), we propose to develop, test, and validate a low-cost, minimally-instrumented POC diagnostic system for rapid detection of 14 individual high-risk HPV genotypes and HIV virus among women in HIV epidemic areas in China. Our POC diagnostic system is unique in: i) adapting a new isothermal amplification strategy for multiplex molecular diagnostics (i.e., HPV, HIV virus), ii) utilizing chemical exothermal reactions to produce the heating for isothermal amplification and freeing its operation from electrical power, and iii) leveraging ubiquitous mobile phone technology to record, analyze and report the results without the need for specialized optical detectors. We propose the following specific aims: i) development and optimization of POC diagnostic system, ii) evaluation and validation of its feasibility for clinical application, and iii) field validations and acceptability evaluation of POC system in HIV epidemic areas of China such as Dehong Prefecture, Yunnan Province. This is a complementary collaboration research between the U.S. PI with the experience on point-of-care diagnostic technology, and the Chinese PI with expertise on cervical cancer screening and field- testing. If successful, this project will readily translate into a new point-of-care tool for cervical cancer screening, which will be of tremendous value in resource poor settings (i.e., rural China) benefiting numerous women.

【摘要】：人乳头瘤病毒(HPV)相关的宫颈癌是最常见的获得性宫颈癌之一。免疫缺陷综合症（艾滋病）相关的恶性肿瘤。宫颈癌是第二大致命癌症已成为中国女性健康的一大威胁，尤其是在中国农村和艾滋病毒流行区。高危型 HPV 是宫颈癌和宫颈癌的病原体世卫组织建议低收入和中等收入国家使用 HPV 检测进行宫颈癌筛查（中低收入国家），例如中国。然而，基于PCR的HPV检测需要昂贵的PCR仪器，并且中低收入国家无力广泛使用。最近新兴的careHPVTM检测，基于核酸杂交检测，提供了相对更简单、更便宜和更便携的 HPV 检测，但对于即时护理 (POC) 诊断应用来说仍然存在许多缺点，包括： i) 相对较长检测时间（约 3 小时），ii) 由训练有素的技术人员使用，以及 iii) 依赖相对昂贵的仪器。在与中国医学科学院肿瘤研究所/医院的研究人员合作（CICAMS），我们建议开发、测试和验证低成本、最少仪器仪表的 POC 诊断快速检测女性HIV感染者中14种高危HPV基因型和HIV病毒的系统中国疫区。我们的 POC 诊断系统的独特之处在于： i) 采用新的等温扩增多重分子诊断策略（即 HPV、HIV 病毒），ii) 利用化学放热反应产生用于等温放大的热量并使其运行摆脱电力，以及 iii) 利用无处不在的移动电话技术来记录、分析和报告结果，而无需专门的光学探测器。我们提出以下具体目标：i）POC的开发和优化诊断系统，ii) 评估和验证其临床应用的可行性，以及 iii) 现场验证德宏州等我国艾滋病流行地区POC系统的可接受性评价云南省。这是美国 PI 与具有以下经验的互补合作研究：床旁诊断技术，以及具有宫颈癌筛查和现场专业知识的中国PI 测试。如果成功，该项目将很容易转化为宫颈癌筛查的新护理点工具，这对于资源匮乏的地区（即中国农村）具有巨大的价值，使众多妇女受益。