One Test, One Kit for Identifying Active Hepatitis C Virus (HCV) Infection at Home

一项测试，一套试剂盒，用于在家中识别活动性丙型肝炎病毒 (HCV) 感染

• 批准号: 10709152
• 负责人: JASON ZHOU
• 金额: $ 40万
• 依托单位: ZYMERON CORPORATION
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-19 至 2023-09-18
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10709152
• 关键词: 3D Print; Biological Assay; Blood; Detection; Devices; Elements; Freeze Drying; Goals; HCV screening; Heating; Hepatitis C; Hepatitis C virus; Home; Instruction; Modeling; Nucleic Acid Amplification Tests; Paper; Plasma; Reagent; Resource-limited setting; Running; Sampling; Sensitivity and Specificity; Specificity; Technology; Testing; Time; Training; base; home test; innovation; isothermal amplification; novel; operation; point of care testing; success; user-friendly; viral RNA

Zymeron aims to develop user-friendly technologies and devices to achieve Hepatitis C Virus (HCV) testing at home. Without special training required, anyone can prepare an HCV RNA sample from fingerprick blood for subsequent isothermal amplification and paper-based nanoenhanced sensitive detection just by following simple instructions. The two innovations that Zymeron will develop to achieve such an aim are (i) an easy to use blood processing device that allows an end user to collect blood from fingerprick and separate plasma automatically; and (ii) a novel paper-based test cassette that integrates multistep nucleic acids amplification testing (NAATs) in one single device. Based on the success of using these proven innovations developed inhouse for Point-of-Care (POC) testing, Zymeron will further advance these technologies to be suitable for home testing of HCV, providing the simplest routine operation for any potential end user to run the kit all by themselves. For a long-term goal, the innovation invented in this proposal will not only benefit specifically for HCV screening but also for other at-home and POC tests in resource-limited settings that rely upon rapid NAAT of plasma samples.

Zymeron旨在开发用户友好的技术和设备，以实现丙型肝炎病毒（HCV）检测， 回家不需要特殊的培训，任何人都可以从手指采血中制备HCV RNA样本， 随后的等温扩增和纸基纳米增强灵敏检测， 简单的指示。Zymeron将开发两项创新来实现这一目标：（i）易于 使用血液处理设备，允许最终用户从指尖收集血液并分离血浆 自动地;和（ii）整合多步核酸扩增的新型纸基测试盒 测试（NAAT）在一个单一的设备。基于成功使用这些内部开发的经过验证的创新技术， 对于床旁（POC）检测，Zymeron将进一步推进这些技术，以适用于 HCV的家庭检测，为任何潜在的最终用户提供最简单的常规操作， 自己对于一个长期目标，本提案中发明的创新不仅会具体受益， 用于HCV筛查，但也用于资源有限的环境中的其他在家和POC测试， 血浆样本的NAAT。