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

丙型肝炎病毒的即时核酸快速检测 CrossLife Technologies Inc. 项目总结/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， 慢性丙型肝炎可导致严重的健康问题，包括肝损伤，肝衰竭， 甚至肝癌。早期发现可以挽救生命。如果抗体测试是反应性的， 需要额外的基于核酸（RNA）的测试，以确定一个人目前是否 感染了丙型肝炎如果RNA测试是阳性的，这意味着一个人目前有 丙型肝炎，应该和医生谈谈，治疗这种疾病。 迫切需要敏感和特异性的床旁（POC）诊断， 丙肝病毒。基于核酸的POC检测有可能提供及时、敏感和 准确诊断HCV，以提供适当的护理和治疗-特别是在环境中 没有强大的临床实验室支持。POC检测法用于区分 哪些HCV血清阳性患者被感染，并确定患者是否有 开发持续的病毒学应答（SVR）将使治疗患者成为可能。 在当今高效泛基因型HCV治疗方案的全球基础上。 因此，我们的目标是开发一种快速，多重测试，检测和基因型所有 在需要时在<30分钟内检测六种HCV基因型， 非实验室环境和非技术人员。我们的专有测试利用了 新型探针反应化学，其允许DNA或RNA的多重检测， 样品纯化，使其可操作为一个简单的，手持测试。患者样本 直接输入到设备中，无需预处理和一次性盒执行 所有目标的扩增和报告可见的结果，可以通过眼睛阅读。我们预计 对相同样品的qRT-PCR数据的灵敏度（> 90%）和特异性（> 90%）。 我们还将进行大规模验证，并获得世界卫生组织（WHO） 加快审查批准和建议采购我们的产品， 首先将其推销给非政府组织，如无医生组织， 边界或盖茨基金会。我们将在第三阶段获得USFDA 510 K许可， 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.