A Simple at-home test for rapid and accurate screening for Hepatitis C Virus (HCV) exposure

提出了一种快速、准确的侧向流动分析(LFA)的原型，用于在家庭环境中对丙型肝炎病毒(HCV)的暴露进行定性自我筛查。LFA使用组成丙型肝炎病毒人类免疫蛋白质组的保守的免疫原域，将在用户产生的指尖血样中检测对这些免疫原性蛋白域的宿主抗体反应。初步验证/可行性将使用来自临床诊断为急性、慢性或缓解的丙型肝炎病毒感染的患者的存档人血清样本来证明。这种高度灵敏和特异的分析方法将足够简单，供自用，并输出最终用户可以在30分钟内直观阅读的结果。预计由此产生的LFA将通过准确识别暴露的个人进行进一步评估，从而对全球公共卫生产生积极影响，并大大有助于降低丙型肝炎病毒的发病率和死亡率；因此，LFA将是有效管理活动性丙型肝炎病毒感染个人的现有工具的宝贵补充。

Development and feasibility demonstration of a prototype rapid and accurate Lateral Flow Assay (LFA) to self-screen qualitatively for exposure to Hepatitis C Virus (HCV) in at-home settings, is proposed. The LFA, employing conserved immunogenic domains of proteins comprising the HCV human immunoproteome, will detect host antibody responses to such immunogenic protein domains in user-generated finger-prick blood samples. Preliminary validation / feasibility will be demonstrated using archived human serum specimens from patients clinically diagnosed to have had acute, chronic, or resolved HCV infection. The highly sensitive and specific assay will be simple enough for self-use, and output results that can be read visually by the end-user within 30 mins. It is anticipated that the resulting LFA will positively impact global public health by accurately identifying exposed individuals for further evaluation and contribute significantly to reducing HCV morbidity and mortality; hence, the LFA will be a valuable addition to the armamentarium of available tools for effective management of individuals with active HCV infection.