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: 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
• 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' 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