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

HCV 快速护理点核酸检测

• 批准号: 9903038
• 负责人: HyunDae Cho
• 金额: $ 99.98万
• 依托单位: CROSSLIFE TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-15 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9903038
• 关键词: Achievement; Acute Hepatitis; Antibodies; Bedside Testings; Biological Assay; Blood; Blood specimen; Buffers; Caring; Chemistry; Chronic; Chronic Hepatitis; Chronic Hepatitis C; Clinical; DNA; Data; Data Set; Detection; Developing Countries; Devices; Diagnostic; Diagnostic tests; Disease; Early Diagnosis; Engineering; Evaluation; Eye; Foundations; Genotype; Goals; Hand; Health; Hepatitis C; Hepatitis C virus; Human Resources; Infection; Laboratories; Ligation; Liquid substance; Liver Cirrhosis; Liver Failure; Liver diseases; Malignant neoplasm of liver; Methods; Microfluidics; Molecular; National Health and Nutrition Examination Survey; Nongovernmental Organizations; Nucleic Acid Amplification Tests; Nucleic Acids; Organism; Outcome Measure; Paper; Patients; Performance; Persons; Phase; Population; Quantitative Reverse Transcriptase PCR; Reaction; Reagent; Recommendation; Refrigeration; Regimen; Reporting; Reproducibility; Resources; Reverse Transcriptase Polymerase Chain Reaction; Saliva; Sampling; Serum; Specificity; Swab; Technology; Temperature; Testing; Time; Training; United States; United States Food and Drug Administration; Universities; Urine; Validation; Washington; World Health Organization; accurate diagnosis; amplification detection; base; cost; cost effective; cross reactivity; design; expedited review; experimental study; innovation; instrument; instrumentation; liver injury; multiplex detection; novel; nucleic acid detection; nucleic acid purification; operation; pathogen; point of care; point-of-care diagnostics; prospective test; response; seropositive; virology

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.

HCV快速，护理核酸测试 Crosslife Technologies Inc. 项目摘要/摘要 每年约有50万人因与肝炎相关的肝病死亡[1]。 丙型肝炎病毒会引起急性和慢性肝炎感染[1-2]。随着时间的推移， 慢性丙型肝炎会引起严重的健康问题，包括肝损伤，肝衰竭， 甚至肝癌。早期发现可以挽救生命。如果抗体测试反应性 需要其他基于核酸的（RNA）测试来确定当前是否是一个人 感染丙型肝炎。如果RNA测试为阳性，这意味着一个人当前有 丙型肝炎，应该与医生交谈并治疗该疾病。 迫切需要敏感和特定的护理点（POC）诊断 HCV。基于核酸的POC测试具有及时，敏感和 对HCV进行适当护理和治疗的准确诊断 - 尤其是在环境中 没有强大的临床实验室支持。 POC分析的可用性以区分 哪些HCV血清阳性患者被感染，并确定患者是否患有 发展的持续病毒反应（SVR）将使治疗患者在 在当前高效的PAN基因型HCV方案的当前时代的全球基础。 因此，我们旨在开发一种快速的多重测试，以检测和基因型所有 在<30分钟内，在需要的六个基因型的HCV基因型，适合 非实验室环境和非技术人员。我们的专有测试利用了 新型的探针反应化学允许对无DNA或RNA的多路复用化学反应化学反应 样品纯化，使其可作为简单的手持测试可用。病人样本为 直接在没有预处理的情况下直接输入到设备中，并且一次性墨盒进行 可以通过眼睛阅读的所有目标和报告可见结果的放大。我们期望 同一样品上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我们产品采购的建议 首先将其推向非政府组织（NGO），例如没有医生 边界或盖茨基金会。我们将在第3阶段获得USFDA 510 K的间隙 为了在美国推销我们的产品