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

• 批准号: 9920096
• 负责人: Changchun Liu
• 金额: $ 15.33万
• 依托单位: UNIVERSITY OF CONNECTICUT SCH OF MED/DNT
• 依托单位国家: 美国
• 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/9920096
• 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 Seronegativity; HIV Seropositivity; HPV-High Risk; Health Personnel; Heating; High Prevalence; Hospitals; Human Characteristics; Human Papillomavirus; Human Resources; Human papilloma virus infection; Individual; Infrastructure; Institutes; Intelligence; 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 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' 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

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。