Rapid point-of-care test for hepatitis C virus (HCV) core antigen to screen active HCV infection

丙型肝炎病毒 (HCV) 核心抗原的快速护理点检测，以筛查活动性 HCV 感染

基本信息

批准号：
10254771
负责人：
Tian Lan
金额：
$ 22.4万
依托单位：
GLUCOSENTIENT, INC.
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-04-01 至 2022-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10254771
关键词：
Adult Amino Acids Anti-Retroviral Agents Antibodies Antigens Area Biological Biological Assay Blood Glucose Blood specimen Buffers Cause of Death Centers for Disease Control and Prevention (U.S.)Cessation of life Chronic Chronic Hepatitis C Cirrhosis Clinical Clinical Research Contracts Custom Developing Countries Development Device or Instrument Development Diagnosis Disease Early Intervention Epidemic Glucose Goals HCV screening Healthcare Hepatitis B Virus Hepatitis C Hepatitis C Antibodies Hepatitis C Prevalence Hepatitis C Vaccine Hepatitis C virus Human Resources Immunoassay Improve Access Individual Infection Infrastructure Intervention Laboratories Lead Life Liver diseases Maintenance Malignant Neoplasms Measures Medical Microfluidics Molecular Diagnostic Testing Nucleic Acid Amplification Tests Nucleic Acids Performance Pharmaceutical Preparations Phase Point-of-Care Systems Population Price Procedures Process Production Quality of life Rapid screening Renal function Risk Sampling Societies Step Tests System Technology Testing Time Training United States Validation Viral Viral Antigens Virus acute infection antibody test antigen test antiretroviral therapy assay development base chronic infection cost curative treatments design detection limit detection platform effective therapy follow-up glucose monitor healing high risk improved infection rate large scale production liver injury meter operation point of care point of care testing prototype research and development scale up screening success vaccine access viral DNA virus core young adult

项目摘要

Project Summary / Abstract The number of people testing positive for hepatitis C virus (HCV) has increased significantly in the last decade and younger adults contracting the virus has become more common. Now, roughly 50,000 infections are expected each year and about 40% of the people are not aware of their infections. Although, about half of these acute infections can be cleared by the individual, the remainder will become chronically infected. If hepatitis C is undiagnosed and remains untreated, severe liver damage and death can occur. HCV related liver damage is now a leading cause of death in the U.S., claiming ~15,000 lives annually. Although no vaccine for HCV is currently available, effective anti-retroviral treatment does exist to treat the disease with over 95% cure rate. Hence, identifying people with hepatitis C (chronic infection) is a critical task to treat and stop the spread of HCV. Currently, screening and diagnosing active HCV infection requires two tests. One antibody test to determine prior exposure and one nucleic acid test (NAT) to confirm an active infection. However, this two-step procedure is cumbersome and heavily relies on clinical laboratories; additionally, the antibody is not sensitive in the first two months of a new HCV infection and missing these cases. Hence, the current testing procedure has become the bottleneck for screening hepatitis C. Besides the current two-step approach, HCV core antigen (cAg) test has been proposed as an equally effective approach for screening and diagnosing active HCV infections. Numerous clinical studies since the 2000s have demonstrated a highly sensitive cAg test can be used to screen active HCV infection as effectively as NAT. However, all currently available HCV cAg test can only be performed in a laboratory setting and require trained personnel for operation and maintenance. As a result, this Phase I project is proposed to demonstrate the feasibility of developing a highly sensitive cAg test that can be performed quickly and accurately at the point-of- care (POC) by utilizing a detection platform based on the existing Blood Glucose Meter (BGM) hardware and a disposable microfluidic assay cartridge. Today’s BGM is the culmination of decades of R&D, designed for small footprint, simple operation, low cost and large-scale production. Leveraging the BGM technology with a familiar assay format for new applications allows us to reduce the risk and costs associated with device development and scale-up production. The final product will be a POC system composed of a BGM based meter and disposable cartridges for HCV cAg for measuring cAg levels in high risk individuals. The new POC HCV cAg test will be able to quickly identify individuals with chronic HCV infection and allow early curative treatment. The proposed product will also greatly benefit developing countries with high HCV prevalence but lacking testing infrastructure. The project will include three development goals, including 1) develop and optimize a highly sensitive cAg test using the BGM platform; 2) validate the BGM based cAg test in biological samples; and 3) integrating the optimized assay with an existing prototype system.

项目摘要 /摘要在过去的十年中患病病毒的年轻人变得越来越普遍。现在，大约有50,000次感染预计每年，大约40％的人不知道自己的感染。虽然，其中约有一半急性感染可以由个体清除，其余的将被长期感染。如果丙型肝炎是未诊断并保持未经治疗，可能会发生严重的肝脏损害和死亡。 HCV相关的肝损伤是现在，美国的主要死亡原因，每年约有15,000人的生命。尽管没有HCV疫苗是当前可用的是，确实存在有效的抗逆转录病毒治疗，以治疗超过95％的治疗率。因此，识别患有丙型肝炎的人（慢性感染）是治疗和停止HCV传播的关键任务。当前，筛查和诊断活性HCV感染需要两次测试。一种抗体测试以确定事先暴露和一项核酸测试（NAT）确认活跃感染。但是，这个两步的过程很麻烦，并且在很大程度上依赖临床实验室；另外，第一个抗体不敏感新的HCV感染两个月，缺少这些病例。因此，当前的测试程序已成为用于筛查肝炎的瓶颈C。除当前的两步方法外，HCV核心抗原（CAG）测试已被提出作为同样有效的筛查和诊断活性HCV感染的方法。自2000年代以来，许多临床研究表现出的高度敏感的CAG测试可用于像NAT一样有效筛选活性HCV感染。但是，目前所有可用的HCV CAG测试只能在实验室环境中进行，需要训练运营和维护人员。结果，提出了此阶段I项目以证明开发高度敏感的CAG测试的可行性，该测试可以在通过使用基于现有的血糖计（BGM）硬件的检测平台和A的护理（POC）一次性微流体测定弹药筒。今天的BGM是数十年的研发的高潮，专为小型设计足迹，简单操作，低成本和大规模生产。用熟悉的针对新应用程序的测定格式使我们能够降低与设备开发相关的风险和成本和扩大生产。最终产品将是由基于BGM的仪表组成的POC系统，用于测量高风险个体CAG水平的HCV CAG的一次性墨盒。新的POC HCV CAG测试将能够快速识别患有慢性HCV感染的人并允许早期治愈治疗。这拟议的产品还将极大地使HCV患病率较高但缺乏测试的发展中国家受益匪浅基础设施。该项目将包括三个发展目标，包括1）开发和优化高度敏感的CAG 使用BGM平台进行测试； 2）在生物样品中验证基于BGM的CAG测试； 3）整合使用现有原型系统优化测定。