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

由人乳头瘤病毒(HPV)引起的宫颈癌是世界上第四种最常见的女性癌症，但在HPV感染发展为侵袭性疾病之前，通过对没有症状的妇女进行筛查是可以预防的。发达国家的筛查项目采用以细胞学为基础的方法(巴氏检测)，然后进行阴道镜检查，这需要高度的组织和管理。在低资源环境，即由于贫穷、缺乏医疗服务提供者、卫生政策不一致、交通和通讯设施不便而导致的低收入国家无法获得这些服务。作为巴氏筛查替代方法的醋酸目视检查已在非洲、亚洲和拉丁美洲得到应用，但这一检查必须由训练有素的卫生保健提供者进行，而且农村地区的专业人员有限，不能进行这种检查。FDA已经批准了几种用于发展中国家高危HPV筛查的聚合酶链式反应设备。但该方法操作复杂、耗时长、费用高，不适合低收入人群。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，可以从多个自收集的宫颈阴道样本中检测高危HPV并进行基因分型，以便在资源有限的地点迅速向医生通报及时治疗的信息。

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.