Rapid Point of Care Test to Screen Human Papillomavirus in Low-Resource Settings

在资源匮乏的环境中筛查人乳头瘤病毒的快速护理点测试

• 批准号: 10897682
• 负责人: QIAN LI
• 金额: $ 1.37万
• 依托单位: ZYMERON CORPORATION
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-07 至 2024-08-06
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10897682
• 关键词: Acetic Acids; Africa; Asia; Biological Assay; Cancer Etiology; Clinical; Colposcopy; Communication; Complex; Consumption; Cytology; Detection; Developed Countries; Developing Countries; Devices; Disease; Genotype; HPV-High Risk; Health Personnel; Health Policy; Human Papillomavirus; Human papilloma virus infection; Latin America; Location; Low income; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Medical; Pap smear; Performance; Physicians; Poverty; Procedures; Provider; Resource-limited setting; Resources; Site; Specimen; Testing; Time; Transportation; Visual; Woman; cervicovaginal; clinical research site; cost; health training; low and middle-income countries; point of care testing; rural setting; screening; screening program

Cervical cancer caused by human papillomavirus (HPV) is the fourth most common cancer among women worldwide, but it is preventable by screening asymptomatic women before HPV infection progresses to an invasive disease. The screening programs in developed countries use the cytology-based approach (Pap testing) followed by colposcopy, which require a high degree of organization and management. They are not available in low-resource settings, i.e., LMICs due to poverty, a lack of medical providers, inconsistent health policies, inconvenient transportation and communication facilities. Visual inspection with acetic acid (VIA) as an alternative to Pap screening has been being applied in Africa, Asia and Latin America, but the procedure must be performed by well-trained health care providers and it is not accessible for the rural places which have limited professional staffs. FDA has approved several PCR devices for high-risk HPV screening in developing countries. However, PCR assay is complex, time consuming, expensive, and is not suitable for the low-income sites. Zymeron develops a rapid (less than 20 min), highly sensitive, and low-cost POC assay to detect and genotype high-risk HPV from multiple self-collected cervicovaginal specimens to rapidly inform physicians on timely treatment in resource-limited sites.

由人乳头瘤病毒（HPV）引起的宫颈癌是全世界女性中第四个最常见的癌症，但是在HPV感染发展为侵入性疾病之前，可以通过筛查无症状女性来预防。发达国家的筛查计划采用基于细胞学的方法（PAP测试），然后进行阴道镜检查，该方法需要高度的组织和管理。它们在低资源环境中不可用，即由于贫困，缺乏医疗服务提供者，不一致的健康政策，不便的交通和通信设施而引起的LMIC。在非洲，亚洲和拉丁美洲已经采用了用乙酸（VIA）视觉检查（VIA）作为PAP筛查的替代方法，但是该程序必须由训练有素的卫生保健提供者进行，并且对于专业员工有限的农村地区无法获得。 FDA批准了多个PCR设备，用于在发展中国家进行高风险的HPV筛查。但是，PCR分析很复杂，耗时，昂贵，并且不适合低收入站点。 Zymeron从多个自我收集的宫颈阴道标本中检测和基因型高风险HPV开发快速（少于20分钟），高度敏感和低成本的POC分析，以迅速向医师迅速告知医生在资源限制的地点及时治疗。