Rapid, Point-of-Care Nucleic Acid Test for HCV

丙型肝炎病毒的快速护理点核酸检测 CrossLife Technologies Inc. 项目摘要/摘要 每年约有50万人死于丙型肝炎相关的肝病[1]。 丙型肝炎病毒可引起急性和慢性肝炎感染[1-2]。随着时间的推移, 慢性丙型肝炎会导致严重的健康问题，包括肝损伤、肝功能衰竭、 甚至是肝癌。及早发现可以挽救生命。如果抗体检测是反应性的， 需要额外的基于核酸(RNA)的测试来确定一个人目前是否 如果RNA检测呈阳性，这意味着一个人目前患有丙型肝炎。 丙型肝炎，应该去看医生，并治疗这种疾病。 迫切需要灵敏和特定的医疗点(POC)诊断 丙型肝炎。基于核酸的POC测试具有提供及时、灵敏和 准确诊断丙型肝炎病毒，以便给予适当的护理和治疗--特别是在环境中 没有强有力的临床实验室支持。POC检测的可用性以区分 哪些丙型肝炎病毒血清阳性患者被感染，并确定患者是否有 开发出持续的病毒学反应(SVR)将使治疗患者成为可能 在当前高效的泛基因型丙型肝炎病毒疗法的全球基础上。 因此，我们的目标是开发一种快速、多重检测方法，用于检测和分型所有 在30分钟内在需要的时候感染六种丙型肝炎病毒，适用于 非实验室环境和非技术人员。我们的专有测试利用了 新的探针反应化学，允许DNA或RNA的多路检测而无需 样品纯化，使其可以作为简单的手持式测试进行操作。病人样本待定 直接输入到设备中，无需进行前处理和一次性墨盒 放大所有目标并报告肉眼可读的可视结果。我们预计 对同一样本的qRT-PCR数据的敏感性(&gt；90%)和特异性(&gt；90%)。 我们还将进行大规模验证，并获得世界卫生组织(WHO) 加快对我们产品和产品的采购的审查、批准和建议 首先向非政府组织(NGO)推销它，如无国界医生组织 边界组织或盖茨基金会。我们将在#年第三阶段获得美国食品和药物管理局510 K许可 为了在美国销售我们的产品。

Rapid, Point-of-Care Nucleic Acid Test for HCV CrossLife Technologies Inc. Project Summary/Abstract Approximately 500 000 people die each year from hepatitis C-related liver diseases [1]. The hepatitis C virus can cause both acute and chronic hepatitis infection [1-2]. Over time, chronic Hepatitis C can cause serious health problems including liver damage, liver failure, and even liver cancer. Early detection can save lives. If the antibody test is reactive, an additional nucleic acids based (RNA) test is needed to determine if a person is currently infected with Hepatitis C. If the RNA test is positive, this means a person currently has Hepatitis C and should talk to a doctor and treating the disease. There is an urgent need for sensitive and specific point-of-care (POC) diagnostics for HCV. Nucleic-acid based POC tests have the potential to offer timely, sensitive and accurate diagnosis of HCV for imparting proper care and treatment – especially in settings without robust clinical laboratory support. The availability of a POC assay to distinguish which HCV seropositive patients are infected and ascertain whether patients have developed a sustained virologic response (SVR) will make it possible to treat patients on a global basis in the current era of highly effective pan-genotypic HCV regimens. Therefore, we aim to develop a rapid, multiplex test that detects and genotypes all six genotypes of HCV at the point-of-need in < 30 minutes and is appropriate for non-laboratory settings and non-technical personnel. Our proprietary test exploits a novel probe reaction chemistry that allows multiplexed detection of DNA or RNA without sample purification, making it operable as a simple, hand-held test. Patient samples to be input directly into the device without pre-processing and a disposable cartridge carry out amplification of all targets and reports visible results that can be read by eye. We expect a sensitivity (>90%) and specificity (>90%) to the qRT-PCR data on the same samples. We will also conduct a large-scale validation and obtain World Health Organization (WHO) expedited review approval and recommendation for procurement on our product and market it first to non-governmental organizations (NGO) such as the Doctors Without Borders or the Gates Foundation. We will obtain USFDA 510 K clearance in Phase 3 in order to market our product in the U.S.