Rapid point-of-care molecular test for HCV VL

HCV VL 快速护理点分子检测

基本信息

批准号：
10330833
负责人：
Jay Kenneth Fisher
金额：
$ 28.87万
依托单位：
REDBUD LABS, 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：
2021-09-01 至 2022-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10330833
关键词：
5&apos Untranslated Regions Affect Algorithms Antibodies Antiviral Agents Biological Assay Blood Chemistry Cirrhosis Clinic Visits Cold Chains Comprehensive Health Care Detection Development Devices Diagnosis Diagnostic Diagnostic tests Diffusion Digit structure Disease Electricity Environment Exposure to Fluorescence Funding Future Genotype Goals Gold HCV screening HIV HIV-1 Hepatitis B Virus Hepatitis C Hepatitis C Antibodies Hepatitis C Prevalence Hepatitis C Therapy Hepatitis C virus High Prevalence Individual Infection Inflammatory Kinetics Laboratories Letters Liver Failure Liver diseases Methods Microfluidic Microchips Microfluidics Molecular Nucleic Acid Amplification Tests Nucleic Acids Oranges Patients Performance Phase Polymerase Population Populations at Risk Preparation Primary carcinoma of the liver cells Production Quantitative Reverse Transcriptase PCR Reagent Resources Rest Routine Diagnostic Tests Running Sampling Sensitivity and Specificity Specificity Specimen System Technology Testing Tube Viral Load result Viremia Vulnerable Populations Work amplification detection antibody test assay development base comorbidity cost design detection limit diagnostic assay follow-up isothermal amplification magnetic beads nucleic acid purification phase 2 study point of care programs recombinase risk minimization scale up success treatment strategy

项目摘要

ABSTRACT Hepatitis C, the inflammatory liver disease caused by hepatitis C virus (HCV), claims approximately 400,000 lives each year from secondary hepatocellular carcinoma and cirrhosis-induced liver failure. Direct-acting antiviral agents can cure > 95% of the estimated 71 million cases of hepatitis C found globally, yet because of underdiagnosis, only 7% of patients are currently receiving treatment. The diagnostic testing algorithm for HCV necessitates multiple clinic visits. Individuals in vulnerable populations often lack the means to meet this high follow-up burden. Increasing the prevalence of HCV treatment to reflect the 95% cure rate requires simplification of diagnostic testing. To this end we will develop a sample-to-answer HCV viral load (VL) test that meets or exceeds the minimal acceptable criteria as defined by the hepatitis C global stakeholder consortium. To achieve this goal, we will combine Redbud Labs’ expertise in microfluidics and systems with the diagnostic assay development expertise of the Diagnostics Program at PATH (Seattle, WA). In Aim 1 Redbud Labs will optimize each assay step to the microfluidic environment using Redbud technologies and commercially available reagents. In Aim 2 PATH will design assay primers and probes. In Aim 3 Redbud Labs will validate the assay by performing it end-to-end using a breadboard system. Redbud technologies are production-ready, which will minimize the risk of degradation in assay performance as we move through cartridge integration in future Phase II work.

抽象的丙型肝炎是由丙型肝炎病毒 (HCV) 引起的炎症性肝病，导致约 400,000 人死亡每年都有人死于继发性肝细胞癌和肝硬化引起的肝功能衰竭。全球发现的约 7100 万丙型肝炎病例中，抗病毒药物可以治愈 95% 以上，但由于诊断不足，目前只有 7% 的患者正在接受 HCV 诊断检测算法的治疗。需要多次就诊，弱势群体中的个人往往缺乏达到如此高水平的手段。增加 HCV 治疗的患病率以反映 95% 的治愈率需要简化。为此，我们将开发一种满足或要求的样本答案 HCV 病毒载量 (VL) 测试。最低限度超过丙型肝炎全球利益相关者联盟定义的可接受标准。为了实现这一目标，我们将把紫荆花实验室在微流体和系统方面的专业知识与诊断技术相结合。 PATH（华盛顿州西雅图）的诊断项目的检测开发专业知识将由 In Aim 1 Redbud Labs 提供。使用紫荆花技术和商业优化微流体环境的每个测定步骤 In Aim 2 PATH 将检测设计引物和探针。 In Aim 3 Redbud Labs 将验证。使用 Redbud 技术进行端到端的检测，已做好生产准备。当我们通过墨盒集成时，这将最大限度地减少分析性能下降的风险未来二期工作。