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

简单的家庭测试，可快速、准确地筛查丙型肝炎病毒 (HCV) 暴露

• 批准号: 10709130
• 负责人: John Manohar
• 金额: $ 39.38万
• 依托单位: PATHOVACS, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-20 至 2023-09-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10709130
• 关键词: Acute; Antibody Response; Archives; Biological Assay; Blood specimen; Characteristics; Chronic; Chronic Hepatitis C; Development; Evaluation; Exposure to; Expression Library; FDA approved; Fingers; Generations; HCV screening; Hepatitis C; Hepatitis C virus; Home; Human; Immune response; Individual; Lateral; Mining; Morbidity - disease rate; Output; Patients; Performance; Proteome; Proteomics; Public Health; Reproducibility; Sensitivity and Specificity; Serum; Specimen; Technology; Tertiary Protein Structure; Validation; antibody test; assay development; base; clinical diagnosis; cross reactivity; detection limit; experimental study; home test; immunogenic; individual response; innovation; lateral flow assay; mortality; prototype; rapid test; screening; self testing; tool

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.

发展和可行性论证的原型快速和准确的侧流试验（LFA），自我筛选定性暴露于丙型肝炎病毒（HCV）在家庭环境中，提出。采用包含HCV人免疫蛋白质组的蛋白质的保守免疫原性结构域的LFA将检测对用户产生的手指采血样品中的此类免疫原性蛋白质结构域的宿主抗体应答。将使用临床诊断为急性、慢性或已消退HCV感染患者的存档人血清标本证明初步验证/可行性。这种高灵敏度和特异性的检测方法非常简单，可供用户自行使用，并可在30分钟内输出最终用户可目视读取的结果。预计由此产生的LFA将通过准确识别暴露个体以进行进一步评估而对全球公共卫生产生积极影响，并显著降低HCV发病率和死亡率;因此，LFA将是有效管理活动性HCV感染个体的现有工具的一个有价值的补充。