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

由人乳头状瘤病毒（HPV）引起的宫颈癌是全球女性中第四大常见癌症，但在HPV感染发展为侵袭性疾病之前，可以通过筛查无症状妇女来预防。发达国家的筛查项目采用细胞学为基础的方法（巴氏涂片检查），然后是阴道镜检查，这需要高度的组织和管理。由于贫穷、缺乏医疗服务提供者、卫生政策不一致、交通和通信设施不方便，在资源匮乏的环境中，即中低收入国家无法获得这些服务。醋酸目视检查（VIA）作为子宫颈涂片检查的替代方法已在非洲、亚洲和拉丁美洲得到应用，但该程序必须由训练有素的卫生保健提供者执行，而且在专业人员有限的农村地区无法使用。FDA已经批准了几种PCR设备用于发展中国家的高危HPV筛查。然而，PCR检测复杂、耗时、昂贵，且不适合低收入位点。Zymeron开发了一种快速（不到20分钟）、高灵敏度和低成本的POC检测方法，可从多个自采集的宫颈阴道标本中检测高风险HPV并进行基因分型，以便在资源有限的地区迅速告知医生及时治疗。

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.